Many people may not realize that symptoms such as chronic cough or chest pain can be caused by acid reflux into the esophagus, because they do not experience classic heartburn symptoms or acid regurgitation. Two new studies presented at the 72nd ACG Annual Scientific Meeting highlight the little known connection between gastroesophageal reflux and seemingly unrelated problems.
Researchers at the Brigham & Women's Hospital in Boston studied patients in emergency rooms who complained of serious chest pain. They measured and recorded pH levels in the esophagus of 31 patients for two days to determine whether excessive acid caused their chest pain. Researchers found more women than men were being rushed to the emergency room with chest pain that was not related to the heart. Abnormal reflux of acid that would fit the diagnosis of GERD was seen in 57 percent of patients. There are two types of acid reflux, supine, which occurs when the patient is sleeping, and upright which occurs when the patient is awake. In this study, men had more upright reflux, while women experienced both reflux during sleep and while they were awake.
According to lead investigator Dr. Julia J. Liu, "Often the role of acid reflux has been overlooked as a potential factor in the diagnosis and treatment of patients with serious chest pain. But, it is important for patients never to assume their chest pain is caused by GERD until they have been thoroughly evaluated by a physician to rule out heart disease. If they experience persistent chest pain, they should seek emergency medical care."
Esophageal Acid Testing: Effective New Technique for Evaluating Patients with Persistent Reflux Related Cough
GERD is one of the most common causes of chronic cough. While persistent cough can be caused by acid reflux, in some cases, the cough could result from the reflux of non-acidic stomach contents. Researchers at the Medical University of South Carolina in Charleston studied a group of patients with persistent cough who took acid-suppression therapy (proton pump inhibitors) over a period of three years to evaluate the cost-effectiveness of MII-pH, a device that can detect reflux without depending on the acidity of the contents that refluxes into the esophagus. Unlike conventional pH monitoring, which measures acidity, this new technique can detect non-acid reflux.
Researchers used a cost-utility analysis to evaluate the cost-effectiveness of this diagnostic intervention among patients on high dose PPI therapy with chronic persistent cough who might be candidates for anti-reflux surgery, such as laparoscopic fundoplication. Researchers included costs of medication use, physician visits and surgery in their model.
According to Dr. Deepika Koya, "The use of MII-pH testing in patients who experience reflux of non-acid stomach contents is cost-effective by helping clinicians determine which patients would benefit from anti-reflux surgery and excluding those for whom surgery may have no benefit. This warrants further evaluation of widespread application of MII-pH testing in the diagnosis of patients with persistent chronic cough on adequate medical therapy."
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Article adapted by Medical News Today from original press release.
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About GERD
GERD is caused by the regurgitation or reflux of gastric fluid into the esophagus. The most common symptom of GERD is frequent or persistent heartburn two or more times a week. Other symptoms of GERD include chest pain, coughing, wheezing, difficulty swallowing, and an acidic or sour aftertaste in the mouth or throat. Each year, GERD accounts for up to 60 percent of patient visits to the emergency room with chest pain not related to the heart, according to the American College of Emergency Physicians.
If you experience severe abdominal pain or chest discomfort, you should seek immediate, emergency medical treatment. By seeing your doctor early, the physical cause of GERD can be treated and more serious problems avoided.
About the American College of Gastroenterology
Founded in 1932, the American College of Gastroenterology (ACG) is an organization with an international membership of more than 10,000 individuals from 80 countries. The College is committed to serving the clinically oriented digestive disease specialist through its emphasis on scholarly practice, teaching and research. The mission of the College is to serve the evolving needs of physicians in the delivery of high quality, scientifically sound, humanistic, ethical, and cost-effective health care to gastroenterology patients.
The ACG is committed to providing accurate, unbiased and up-to-date health information. Visit the ACG Web site American College of Gastroenterology to access educational resources for patients and their families spanning the broad range of digestive diseases and conditions -- both common and not-so-common. Organized by disease, state and organ system, these educational materials, developed by ACG physician experts, are offered for the information and benefit of patients and the public.
Source: Rosanne Riesenman
American College of Gastroenterology
Wednesday, March 18, 2009
Survey Reveals Heartburn Sufferers Experience More Heartburn During The Holidays
Heartburn remains a burning problem for more than 60 million Americans each month(1), and this November, the National Heartburn Alliance (NHBA) is recognizing the need for heartburn education by sponsoring the first ever Heartburn Awareness Month.
Recent survey results show that 66% of people experience heartburn symptoms during the holiday season. Additionally, and overwhelming 94% of people said they would enjoy the holidays more if they didn't have to worry about heartburn.
"November is a perfect time for heartburn sufferers and healthcare professionals to address heartburn, because more people tend to over-indulge in holiday meals," says Pat Baird, Registered Dietitian and NHBA Board member. "By incorporating lifestyle changes into their diets, heartburn sufferers can learn to alleviate symptoms so they can enjoy the holidays."
Pat Baird offers these for a "heartburn friendly" holiday season:
-- Don't overindulge. Allow yourself to eat your favorite holiday foods, but try smaller portions. Keep in mind that too much of a good thing can lead to heartburn.
-- Avoid heartburn triggers. Red wine, foods with high fat content, and spices are just a few common heartburn triggers.
-- Control late night munchies. Try not to eat late at night or right before going to bed to decrease your chances of suffering from nighttime heartburn.
-- Keep your cool. Stress levels tend to increase during the holidays. Relax by taking a few moments for yourself each day. Consider taking a 10-minute walk after a holiday dinner for some stress-free quite time.
-- Moderation is the key. From Thanksgiving to New Year's Eve, holiday celebrations and alcoholic beverages are plentiful. If you are going to drink, choose cocktails that are easier on the tummy, such as a wine spritzer (white wine and club soda).
The goal of Heartburn Awareness Month is to screen, educate and treat heartburn sufferers. The NHBA encourages all heartburn sufferers to proactively visit their healthcare providers during the month of November, to receive information about heartburn so they can eliminate symptoms when they are more likely to indulge in holiday meals and spirits.
"Many people don't know that the foods and drinks they enjoy around the holidays may contribute to heartburn symptoms," says Jan Engle, Pharm.D. at the University of Chicago at Illinois and NHBA Vice Chair. "Heartburn Awareness Month in November raises awareness about these triggers so that sufferers can find the appropriate treatment options and enjoy their holidays."
Additional Survey Results
-- 94% of adults surveyed believed that over-eating is the cause of holiday heartburn; 18% of those surveyed blamed eating at abnormal hours and 16% believe stress is the main factor or holiday heartburn
-- 55% of survey respondents believe that eating highly acidic foods during the holidays is the reason they suffer from heartburn, followed by eating fatty meats (20%) and drinking alcohol (11%)
The National Heartburn Alliance is an organization dedicated to improving the lives of heartburn sufferers through education, information and support. Nationally recognized health care professionals, including experts in digestive disease, pharmacy, nutrition and nursing, comprise the Alliance. The NHBA receives support and sponsorship from the P&G Health Sciences Institute (http://pghsi.com).
Synovate Inc.'s online Global Opinion Panel was used as the sample source for this study. This is a national household database consisting of over 1.4 million households that have agreed to participate in survey research. The study included 1,000 representative interviews among adults age 18 to 65, and is balanced to be representative of the general population based upon region, gender, age and household income data from the U.S. Census Bureau. The selected individuals receive a customized e-mail inviting them to participate in the survey. The survey consists of a shared set of standard demographic questions.
Recent survey results show that 66% of people experience heartburn symptoms during the holiday season. Additionally, and overwhelming 94% of people said they would enjoy the holidays more if they didn't have to worry about heartburn.
"November is a perfect time for heartburn sufferers and healthcare professionals to address heartburn, because more people tend to over-indulge in holiday meals," says Pat Baird, Registered Dietitian and NHBA Board member. "By incorporating lifestyle changes into their diets, heartburn sufferers can learn to alleviate symptoms so they can enjoy the holidays."
Pat Baird offers these for a "heartburn friendly" holiday season:
-- Don't overindulge. Allow yourself to eat your favorite holiday foods, but try smaller portions. Keep in mind that too much of a good thing can lead to heartburn.
-- Avoid heartburn triggers. Red wine, foods with high fat content, and spices are just a few common heartburn triggers.
-- Control late night munchies. Try not to eat late at night or right before going to bed to decrease your chances of suffering from nighttime heartburn.
-- Keep your cool. Stress levels tend to increase during the holidays. Relax by taking a few moments for yourself each day. Consider taking a 10-minute walk after a holiday dinner for some stress-free quite time.
-- Moderation is the key. From Thanksgiving to New Year's Eve, holiday celebrations and alcoholic beverages are plentiful. If you are going to drink, choose cocktails that are easier on the tummy, such as a wine spritzer (white wine and club soda).
The goal of Heartburn Awareness Month is to screen, educate and treat heartburn sufferers. The NHBA encourages all heartburn sufferers to proactively visit their healthcare providers during the month of November, to receive information about heartburn so they can eliminate symptoms when they are more likely to indulge in holiday meals and spirits.
"Many people don't know that the foods and drinks they enjoy around the holidays may contribute to heartburn symptoms," says Jan Engle, Pharm.D. at the University of Chicago at Illinois and NHBA Vice Chair. "Heartburn Awareness Month in November raises awareness about these triggers so that sufferers can find the appropriate treatment options and enjoy their holidays."
Additional Survey Results
-- 94% of adults surveyed believed that over-eating is the cause of holiday heartburn; 18% of those surveyed blamed eating at abnormal hours and 16% believe stress is the main factor or holiday heartburn
-- 55% of survey respondents believe that eating highly acidic foods during the holidays is the reason they suffer from heartburn, followed by eating fatty meats (20%) and drinking alcohol (11%)
The National Heartburn Alliance is an organization dedicated to improving the lives of heartburn sufferers through education, information and support. Nationally recognized health care professionals, including experts in digestive disease, pharmacy, nutrition and nursing, comprise the Alliance. The NHBA receives support and sponsorship from the P&G Health Sciences Institute (http://pghsi.com).
Synovate Inc.'s online Global Opinion Panel was used as the sample source for this study. This is a national household database consisting of over 1.4 million households that have agreed to participate in survey research. The study included 1,000 representative interviews among adults age 18 to 65, and is balanced to be representative of the general population based upon region, gender, age and household income data from the U.S. Census Bureau. The selected individuals receive a customized e-mail inviting them to participate in the survey. The survey consists of a shared set of standard demographic questions.
Astrazeneca Receives First European Approval For Nexium(R) In Pediatric Gerd
AstraZeneca announced that it has received Swedish Medical Products Agency (MPA) approval for use of Nexium(R) (esomeprazole) in children aged 1-11 years with gastroesophageal reflux disease (GERD) in the reference member state of Sweden, with other European Union nations expected to follow.1
Nexium® will become the first of the proton pump inhibitors (PPI) currently available for the treatment of pediatric GERD to have a specific formulation developed for children.1
Children with GERD can experience disruptive symptoms on an everyday basis, with a recent AstaZeneca survey indicating that school performance, sleeping habits and social activities were all affected by the condition. 2 Furthermore, the impact of symptoms can be distressing for not only the child but also their parents and / or caregivers. 2
Nexium, which is licensed for treatment of GERD, will be available in a 10 mg sachet formulation of acid resistant pellets, which are dispersed in liquid. The sachet has a mild citrus-taste and does not contain any artificial flavours. Nexium® also provides the added flexibility of administration via nasogastric or gastric tube. 1
In making its recommendations, the MPA reviewed data from a range of safety and pharmacokinetic studies that investigated symptom improvement and healing as secondary endpoints. 3-6 These included a multicentre parallel group study conducted in 109 children aged 1-11 years with endoscopically proven GERD, of whom almost half had erosive esophagitis. Patients were stratified on the basis of weight and were randomized within each group to receive treatment for 8 weeks (5 or 10 mg esomeprazole [< 20kg] and 10 or 20 mg [> 20kg]) 6
Patient diary assessments by the parent/guardian showed that among the 58 patients who had moderate to severe symptoms (heartburn, acid regurgitation and epigastric pain) at baseline, over 90% experienced symptomatic improvement after treatment with Nexium.5 Reflux esophagitis was healed in the majority of patients 6 and Nexium was also shown to be generally well tolerated in the patient population.5
In children, Nexium® is approved for the treatment of GERD patients aged 1-17 years1. It is also currently under clinical evaluation for the treatment of GERD in even younger children, aged 0 - 1 year.
In adults, Nexium® is approved in Europe for the treatment of heartburn and other symptoms associated with acid reflux (GERD), for the treatment of reflux esophagitis and for the long-term management of patients with healed esophagitis to prevent relapse. Nexium® is also indicated in the EU for healing of gastric ulcers associated with NSAID therapy and prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk. 1
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For further information, please visit http://www.astrazeneca.com.
GERD
Gastroesophageal reflux disease (GERD) is a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications7. Symptoms can disrupt the physical, social and emotional wellbeing of many patients in spite of efforts to manage their condition8 .
In a practiced-based study, heartburn and acid regurgitation were reported as occurring on a weekly basis in approximately 2% of 3-9 year old children and about 5-8% of 10-17 year olds9
References
1. Nexium Prescribing Information, AstraZeneca
2. Parents' Perspectives on GERD, AstraZeneca Survey. September, 2006
3. Zhao J, Li J, Hamer-Maansson JE, Andersson T, Fulmer R, Illueca M, Lundborg P. Pharmacokinetic properties of esomeprazole in children aged 1 to 11 years with symptoms of gastroesophageal reflux disease: a randomized, open-label study. Clinical Therapeutics 2006;28(11):1868-76.
4. Tolia V, Gilger MA, Barker PN, Illueca M. Healing of erosive esophagitis (EE) and improvement in symptoms of gastroesophageal reflux disease (GERD) in 1- and 2-year-old children after esomeprazole treatment. Gastrointestinal Endoscopy 2007; 65(5 Suppl 1): AB118 , Abs 670.
5. Gilger M, Tolia V, Vandenplas Y, Youssef N, Traxler B, Illueca M. Safety and tolerability of esomeprazole in children with gastroesophageal reflux disease. Journal of Pediatric Gastroenterology and Nutrition 2006;43(4) :E20-1, Abs 23.
6. Tolia V, Youssef N, Belknap W, Gilger M, Traxler B, Illueca M. Treatment of erosive esophagitis with esomeprazole in children with gastroesophageal reflux disease. Journal of Pediatric Gastroenterology and Nutrition 2006; 43(4): E20, Abs 22.
7. Vakil N, Van Zanten SV, Kahrilas P, Dent J, Jones R and the Global Consensus Group. The Montreal Definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol 2006;101:1900-20.
8. Liker H, Hungin P, Wiklund I. Managing gastroesophageal reflux disease in primary care: the patient perspective. J Am Board Fam Pract 2005;18:393-400.
9. Nelson SP, Chen EH, Syniar GM, Christoffel KK. Prevalence of symptoms of gastroesophageal reflux during childhood: a pediatric practice-based survey. Pediatric Practice Research Group. Arch Pediatr Adolesc Med 2000;154:150-4.
Nexium® will become the first of the proton pump inhibitors (PPI) currently available for the treatment of pediatric GERD to have a specific formulation developed for children.1
Children with GERD can experience disruptive symptoms on an everyday basis, with a recent AstaZeneca survey indicating that school performance, sleeping habits and social activities were all affected by the condition. 2 Furthermore, the impact of symptoms can be distressing for not only the child but also their parents and / or caregivers. 2
Nexium, which is licensed for treatment of GERD, will be available in a 10 mg sachet formulation of acid resistant pellets, which are dispersed in liquid. The sachet has a mild citrus-taste and does not contain any artificial flavours. Nexium® also provides the added flexibility of administration via nasogastric or gastric tube. 1
In making its recommendations, the MPA reviewed data from a range of safety and pharmacokinetic studies that investigated symptom improvement and healing as secondary endpoints. 3-6 These included a multicentre parallel group study conducted in 109 children aged 1-11 years with endoscopically proven GERD, of whom almost half had erosive esophagitis. Patients were stratified on the basis of weight and were randomized within each group to receive treatment for 8 weeks (5 or 10 mg esomeprazole [< 20kg] and 10 or 20 mg [> 20kg]) 6
Patient diary assessments by the parent/guardian showed that among the 58 patients who had moderate to severe symptoms (heartburn, acid regurgitation and epigastric pain) at baseline, over 90% experienced symptomatic improvement after treatment with Nexium.5 Reflux esophagitis was healed in the majority of patients 6 and Nexium was also shown to be generally well tolerated in the patient population.5
In children, Nexium® is approved for the treatment of GERD patients aged 1-17 years1. It is also currently under clinical evaluation for the treatment of GERD in even younger children, aged 0 - 1 year.
In adults, Nexium® is approved in Europe for the treatment of heartburn and other symptoms associated with acid reflux (GERD), for the treatment of reflux esophagitis and for the long-term management of patients with healed esophagitis to prevent relapse. Nexium® is also indicated in the EU for healing of gastric ulcers associated with NSAID therapy and prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk. 1
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For further information, please visit http://www.astrazeneca.com.
GERD
Gastroesophageal reflux disease (GERD) is a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications7. Symptoms can disrupt the physical, social and emotional wellbeing of many patients in spite of efforts to manage their condition8 .
In a practiced-based study, heartburn and acid regurgitation were reported as occurring on a weekly basis in approximately 2% of 3-9 year old children and about 5-8% of 10-17 year olds9
References
1. Nexium Prescribing Information, AstraZeneca
2. Parents' Perspectives on GERD, AstraZeneca Survey. September, 2006
3. Zhao J, Li J, Hamer-Maansson JE, Andersson T, Fulmer R, Illueca M, Lundborg P. Pharmacokinetic properties of esomeprazole in children aged 1 to 11 years with symptoms of gastroesophageal reflux disease: a randomized, open-label study. Clinical Therapeutics 2006;28(11):1868-76.
4. Tolia V, Gilger MA, Barker PN, Illueca M. Healing of erosive esophagitis (EE) and improvement in symptoms of gastroesophageal reflux disease (GERD) in 1- and 2-year-old children after esomeprazole treatment. Gastrointestinal Endoscopy 2007; 65(5 Suppl 1): AB118 , Abs 670.
5. Gilger M, Tolia V, Vandenplas Y, Youssef N, Traxler B, Illueca M. Safety and tolerability of esomeprazole in children with gastroesophageal reflux disease. Journal of Pediatric Gastroenterology and Nutrition 2006;43(4) :E20-1, Abs 23.
6. Tolia V, Youssef N, Belknap W, Gilger M, Traxler B, Illueca M. Treatment of erosive esophagitis with esomeprazole in children with gastroesophageal reflux disease. Journal of Pediatric Gastroenterology and Nutrition 2006; 43(4): E20, Abs 22.
7. Vakil N, Van Zanten SV, Kahrilas P, Dent J, Jones R and the Global Consensus Group. The Montreal Definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol 2006;101:1900-20.
8. Liker H, Hungin P, Wiklund I. Managing gastroesophageal reflux disease in primary care: the patient perspective. J Am Board Fam Pract 2005;18:393-400.
9. Nelson SP, Chen EH, Syniar GM, Christoffel KK. Prevalence of symptoms of gastroesophageal reflux during childhood: a pediatric practice-based survey. Pediatric Practice Research Group. Arch Pediatr Adolesc Med 2000;154:150-4.
ASGE Offers Guidelines On Endoscopic Treatment Of Dyspepsia
The American Society for Gastrointestinal Endoscopy (ASGE) has issued guidelines for the role of endoscopy in treating dyspepsia, discomfort thought to arise from the upper-gastrointestinal tract, which affects a fourth of the population in Western countries. An upper endoscopy is a procedure which uses an instrument to evaluate the inside of the esophagus, stomach and small intestine. The guidelines, prepared by ASGE's Standards of Practice Committee, appear in the December issue of Gastrointestinal Endoscopy, the monthly peer-reviewed scientific journal of the American Society for Gastrointestinal Endoscopy.
Dyspepsia may encompass a variety of more specific symptoms, including epigastric discomfort, bloating, anorexia, and heartburn. These nonspecific symptoms can be indicative of an underlying diagnosis such as peptic ulcer disease, GERD, functional disorders (nonulcer dyspepsia), and malignancy. The appropriate role of endoscopy in the evaluation of dyspepsia is both a pragmatic concern for the gastroenterologist and an important determinant in healthcare costs.
"Since dyspepsia affects large numbers of people across a broad spectrum of symptoms, it is not practical to perform endoscopy in all patients with dyspepsia," said Todd Baron, MD, chair of the ASGE Standards of Practice Committee. "In review of the medical data available, we concluded in these guidelines that age and alarm features offer the best guidance for the physician in managing patients and in determining if an endoscopy is appropriate treatment."
Patients With Alarm Features (Symptoms)
Dyspepsia is not only a convenient descriptor for upper-gastrointestinal (GI) symptoms, but also a marker for the risk of structural disease: malignancy is present in 1 to 3 percent of patients with dyspepsia, and peptic ulcer disease in another 5 to 15 percent. Endoscopy offers the potential for early diagnosis of structural disease.
Age and alarm features have been used in an attempt to identify those patients with dyspepsia who harbor structural disease. Alarm features include new onset of symptoms in someone over 50, family history of upper-GI malignancy, unintended weight loss, GI bleeding or iron deficiency anemia, progressive trouble swallowing, pain with swallowing, persistent vomiting, palpable mass or lymphadenopathy, and jaundice.
The guidelines recommend that patients older than 50 years of age with recent onset of dyspepsia or patients of any age with alarm features should undergo an endoscopy. An endoscopy should also be considered for patients in whom there is a clinical suspicion of malignancy even in the absence of alarm features.
Patients Without Alarm Features
Patients with dyspepsia who are younger than age 50 and without alarm features are commonly evaluated by one of three methods: noninvasive testing for Helicobacter pylori (H. pylori), with subsequent treatment if positive (the "test-and-treat" approach), a trial of acid suppression or an initial endoscopy.
In many patients with dyspepsia who have peptic ulcer disease, H. pylori infection will be present. Noninvasive testing options for this infection include a blood test, urea breath testing (UBT), and stool antigen. There is growing evidence that patients who are managed with the test-and-treat approach have similar outcomes when compared with those undergoing initial endoscopy. In addition, the test-and-treat approach is more cost effective. Results from a meta-analysis of five randomized studies of test-and-treat versus an initial endoscopy showed a negligible improvement of symptoms in the endoscopy group, but a savings of $389 per patient in the test-and-treat group.
Many investigators and societies advocate acid-suppressive therapy as the initial strategy for patients with dyspepsia. Proton pump inhibitors (PPI) are more effective than H2 blockers in this approach. Initiation of empiric acid suppression will not address underlying H. pylori in those patients with H. pylori-associated peptic ulcer disease, risking recurrent symptoms when acid suppression is withdrawn. This may prompt long-term acid suppression if no further investigation is performed.
One advantage of early endoscopy is the possibility of establishing a specific diagnosis, such as peptic ulcer disease or erosive esophagitis. The risk of malignancy is quite low in young patients without alarm features. Many patients, however, with early stage malignancy do not have alarm symptoms. Another advantage of a negative endoscopy in the evaluation of patients with dyspepsia is a reduction in anxiety and an increase in patient satisfaction. Yet, there is little evidence to suggest significant improvement in outcomes by the initial endoscopy approach. Most studies demonstrate an increased cost with the initial endoscopic approach compared with the test-and-treat method.
Recommendations
* Patients with dyspepsia who are older than 50 years of age and/or those with alarm features should undergo endoscopic evaluation
* Patients with dyspepsia who are younger than 50 years of age and without alarm features may undergo an initial test-and-treat approach for H. pylori
* Patients who are younger than 50 years of age and are H. pylori negative can be offered an initial endoscopy or a short trial of PPI acid suppression
* Patients with dyspepsia who do not respond to empiric PPI therapy or have recurrent symptoms after an adequate trial should undergo endoscopy
Dyspepsia may encompass a variety of more specific symptoms, including epigastric discomfort, bloating, anorexia, and heartburn. These nonspecific symptoms can be indicative of an underlying diagnosis such as peptic ulcer disease, GERD, functional disorders (nonulcer dyspepsia), and malignancy. The appropriate role of endoscopy in the evaluation of dyspepsia is both a pragmatic concern for the gastroenterologist and an important determinant in healthcare costs.
"Since dyspepsia affects large numbers of people across a broad spectrum of symptoms, it is not practical to perform endoscopy in all patients with dyspepsia," said Todd Baron, MD, chair of the ASGE Standards of Practice Committee. "In review of the medical data available, we concluded in these guidelines that age and alarm features offer the best guidance for the physician in managing patients and in determining if an endoscopy is appropriate treatment."
Patients With Alarm Features (Symptoms)
Dyspepsia is not only a convenient descriptor for upper-gastrointestinal (GI) symptoms, but also a marker for the risk of structural disease: malignancy is present in 1 to 3 percent of patients with dyspepsia, and peptic ulcer disease in another 5 to 15 percent. Endoscopy offers the potential for early diagnosis of structural disease.
Age and alarm features have been used in an attempt to identify those patients with dyspepsia who harbor structural disease. Alarm features include new onset of symptoms in someone over 50, family history of upper-GI malignancy, unintended weight loss, GI bleeding or iron deficiency anemia, progressive trouble swallowing, pain with swallowing, persistent vomiting, palpable mass or lymphadenopathy, and jaundice.
The guidelines recommend that patients older than 50 years of age with recent onset of dyspepsia or patients of any age with alarm features should undergo an endoscopy. An endoscopy should also be considered for patients in whom there is a clinical suspicion of malignancy even in the absence of alarm features.
Patients Without Alarm Features
Patients with dyspepsia who are younger than age 50 and without alarm features are commonly evaluated by one of three methods: noninvasive testing for Helicobacter pylori (H. pylori), with subsequent treatment if positive (the "test-and-treat" approach), a trial of acid suppression or an initial endoscopy.
In many patients with dyspepsia who have peptic ulcer disease, H. pylori infection will be present. Noninvasive testing options for this infection include a blood test, urea breath testing (UBT), and stool antigen. There is growing evidence that patients who are managed with the test-and-treat approach have similar outcomes when compared with those undergoing initial endoscopy. In addition, the test-and-treat approach is more cost effective. Results from a meta-analysis of five randomized studies of test-and-treat versus an initial endoscopy showed a negligible improvement of symptoms in the endoscopy group, but a savings of $389 per patient in the test-and-treat group.
Many investigators and societies advocate acid-suppressive therapy as the initial strategy for patients with dyspepsia. Proton pump inhibitors (PPI) are more effective than H2 blockers in this approach. Initiation of empiric acid suppression will not address underlying H. pylori in those patients with H. pylori-associated peptic ulcer disease, risking recurrent symptoms when acid suppression is withdrawn. This may prompt long-term acid suppression if no further investigation is performed.
One advantage of early endoscopy is the possibility of establishing a specific diagnosis, such as peptic ulcer disease or erosive esophagitis. The risk of malignancy is quite low in young patients without alarm features. Many patients, however, with early stage malignancy do not have alarm symptoms. Another advantage of a negative endoscopy in the evaluation of patients with dyspepsia is a reduction in anxiety and an increase in patient satisfaction. Yet, there is little evidence to suggest significant improvement in outcomes by the initial endoscopy approach. Most studies demonstrate an increased cost with the initial endoscopic approach compared with the test-and-treat method.
Recommendations
* Patients with dyspepsia who are older than 50 years of age and/or those with alarm features should undergo endoscopic evaluation
* Patients with dyspepsia who are younger than 50 years of age and without alarm features may undergo an initial test-and-treat approach for H. pylori
* Patients who are younger than 50 years of age and are H. pylori negative can be offered an initial endoscopy or a short trial of PPI acid suppression
* Patients with dyspepsia who do not respond to empiric PPI therapy or have recurrent symptoms after an adequate trial should undergo endoscopy
Using Newly Approved Device, Doctors Do "incision-less" GERD Surgery
If you're constantly reaching for antacids to control your heartburn, you may have a more serious problem called reflux disease. Some 25 million Americans have it* and now they have a new option to treat it. Using a newly-approved device for the first time in the U.S., doctors have performed surgery to fix reflux problems without making a single incision.
Developing the technology took decades, but the operation only took an hour. When it was over, doctors at Ohio State University Medical Center may have ushered in a new era of surgery when it comes to fixing reflux problems. Experts at OSUMC say they're the first in the U.S. to use recently approved remote control instruments to repair the valve between the esophagus and stomach without using a scalpel.
"This device eliminates the need for any incisions whatsoever. The entire reconstruction, or rebuilding of the valve, can be done from the inside all with an instrument through the mouth," says Scott Melvin, MD, at Ohio State University Medical Center.
By going entirely through a patient's mouth, doctors don't have to cut into the body. That can dramatically cut down on recovery time and the risk of complications. Gertrude Green was one of the first patients in the country to try the procedure, after 20 years of trying nearly everything else to control her reflux.
"Over the last 20 years I've taken over-the-counter medications, prescriptions and seen more than one doctor," says Green.
Gertrude has known for years that surgery was an option, but in the past, it was more invasive and would require more time to recover. Now this new technique can change that and possibly more.
"Reflux can give people heartburn, but it also has been associated with an increased risk of esophageal cancer. Right now in North America, esophageal cancer has increased dramatically over the last decade - doubling even tripling the number of cases," says Melvin.
It's too early to tell if this surgery will impact the number of cancer cases, but it's clear to patients like Gertrude that it's already addressed the burning issue of reflux.
Doctors say getting heartburn once in a while is normal. If you get it 3 or 4 times a week, you should get it checked. Right now, through-the-mouth surgery is only available at certain hospitals. It is expected to become more common in the coming years.
Developing the technology took decades, but the operation only took an hour. When it was over, doctors at Ohio State University Medical Center may have ushered in a new era of surgery when it comes to fixing reflux problems. Experts at OSUMC say they're the first in the U.S. to use recently approved remote control instruments to repair the valve between the esophagus and stomach without using a scalpel.
"This device eliminates the need for any incisions whatsoever. The entire reconstruction, or rebuilding of the valve, can be done from the inside all with an instrument through the mouth," says Scott Melvin, MD, at Ohio State University Medical Center.
By going entirely through a patient's mouth, doctors don't have to cut into the body. That can dramatically cut down on recovery time and the risk of complications. Gertrude Green was one of the first patients in the country to try the procedure, after 20 years of trying nearly everything else to control her reflux.
"Over the last 20 years I've taken over-the-counter medications, prescriptions and seen more than one doctor," says Green.
Gertrude has known for years that surgery was an option, but in the past, it was more invasive and would require more time to recover. Now this new technique can change that and possibly more.
"Reflux can give people heartburn, but it also has been associated with an increased risk of esophageal cancer. Right now in North America, esophageal cancer has increased dramatically over the last decade - doubling even tripling the number of cases," says Melvin.
It's too early to tell if this surgery will impact the number of cancer cases, but it's clear to patients like Gertrude that it's already addressed the burning issue of reflux.
Doctors say getting heartburn once in a while is normal. If you get it 3 or 4 times a week, you should get it checked. Right now, through-the-mouth surgery is only available at certain hospitals. It is expected to become more common in the coming years.
Acid Reflux Study Looks At Lifespan Of Sufferers
Gastroesophageal reflux disease (GERD), often known as acid reflux, is a common problem that has been associated with cancers, asthma, recurrent aspiration and pulmonary fibrosis. A new study published in The American Journal of Gastroenterology examines whether GERD sufferers may have shorter lifespans than those without the disease.
Drawing on over 50,000 person-years of data, the study provides reassuring evidence that people with acid reflux symptoms do not have an increased risk of death, finding no difference in survival rates between sufferers and non-sufferers.
In fact, the study finds that people with infrequent acid reflux may actually have better survival rates than those with either daily symptoms, or none at all. "It may be that occasional reflux symptoms are a reflection of potential protective behaviors that are associated with reflux, such as regular exercise or modest amounts of alcohol ingestion," suggest Nicholas J. Talley and G. Richard Locke, III, co-authors of the study.
The study adds perspective to the risk of acid reflux symptoms. While there are a large number of acid reflux sufferers in the U.S., incidences of related cancer are extremely rare. "Although extraesophageal manifestations occur in some people with reflux disease, our results suggest that this disease is a benign condition in the vast majority of sufferers," say the authors.
Drawing on over 50,000 person-years of data, the study provides reassuring evidence that people with acid reflux symptoms do not have an increased risk of death, finding no difference in survival rates between sufferers and non-sufferers.
In fact, the study finds that people with infrequent acid reflux may actually have better survival rates than those with either daily symptoms, or none at all. "It may be that occasional reflux symptoms are a reflection of potential protective behaviors that are associated with reflux, such as regular exercise or modest amounts of alcohol ingestion," suggest Nicholas J. Talley and G. Richard Locke, III, co-authors of the study.
The study adds perspective to the risk of acid reflux symptoms. While there are a large number of acid reflux sufferers in the U.S., incidences of related cancer are extremely rare. "Although extraesophageal manifestations occur in some people with reflux disease, our results suggest that this disease is a benign condition in the vast majority of sufferers," say the authors.
Hospitalizations Due To GERD Rose 103% Between 1998 And 2005, USA
The number of people hospitalized because of GERD (gastroesophageal reflux disease) in the USA rose 103% between the period 1998 and 2005, according to details published by the Agency for Healthcare Research and Quality (AHRC). During that same period there was a 216% rise in the number of patients hospitalized for other ailments but who also had milder forms of GERD.
A person who suffers GERD experiences chronic heartburn because stomach acid backs up into the esophagus. Left untreated GERD can cause bleeding in the esophagus, the patient may have difficulty swallowing - in some extreme cases cancer of the esophagus can develop.
The AHRQ also reports that the number of people hospitalized just for GERD rose from 91,000 in 1998 to 95,000 in 2005, an increase of about 5%. Among those hospitalizations, the number of people suffering from severe symptoms, such as vomiting, anemia and weight loss rose 39%. There was a 43% increase in the number of patients hospitalized for less severe symptoms, such as chronic coughing, bloating, belching and hoarseness.
During the same period there was an 84% increase in the number of 2-17 year olds hospitalized for GERD, and a 42% increase among infant under the age of 2.
A person who suffers GERD experiences chronic heartburn because stomach acid backs up into the esophagus. Left untreated GERD can cause bleeding in the esophagus, the patient may have difficulty swallowing - in some extreme cases cancer of the esophagus can develop.
The AHRQ also reports that the number of people hospitalized just for GERD rose from 91,000 in 1998 to 95,000 in 2005, an increase of about 5%. Among those hospitalizations, the number of people suffering from severe symptoms, such as vomiting, anemia and weight loss rose 39%. There was a 43% increase in the number of patients hospitalized for less severe symptoms, such as chronic coughing, bloating, belching and hoarseness.
During the same period there was an 84% increase in the number of 2-17 year olds hospitalized for GERD, and a 42% increase among infant under the age of 2.
Hospitalizations For GERD Up By 103 Percent
Hospitalizations for treating disorders caused by gastroespohageal reflux disease (GERD ) increased by 103 percent between 1998 and 2005, according to the latest News and Numbers from the Agency for Healthcare Research and Quality. During the same period, hospitalizations of patients who, in addition to the ailment for which they were admitted, had milder forms of GERD, rose by 216 percent.
In patients with GERD, stomach acid backs up into the esophagus, causing extreme, chronic heartburn. If untreated, GERD can cause esophageal disorders such as bleeding, trouble swallowing, Barrett's esophagus, a precancerous condition, and in extreme cases, cancer of the esophagus.
AHRQ also found that:
-- Hospitalizations specifically for GERD increased roughly 5 percent, as a whole, during the period from roughly 91,000 to 95,000.
-- Among these, admissions of patients who had severe symptoms, such as anemia, vomiting and weight loss, increased by 39 percent. Hospitalizations for patients with less serious symptoms, such as hoarseness and chronic coughing, bloating, or belching, rose 43 percent.
-- Hospitalizations for GERD in children ages 2 to 17 rose by 84 percent during the period, and 42 percent for infants under age 2.
This AHRQ News and Numbers is based on data in "Gastroesophageal Reflux Disease (GERD) Hospitalizations in 1998 and 2005". The report uses statistics from the Nationwide Inpatient Sample, a database of hospital inpatient stays that is nationally representative of inpatient stays in all short-term, non-Federal hospitals. The data are drawn from hospitals that comprise 90 percent of all discharges in the United States and include all patients, regardless of insurance type, as well as the uninsured.
Agency for Healthcare Research and Quality (AHRQ)
540 Gaither Rd.
Rockville, MD 20850
United States
In patients with GERD, stomach acid backs up into the esophagus, causing extreme, chronic heartburn. If untreated, GERD can cause esophageal disorders such as bleeding, trouble swallowing, Barrett's esophagus, a precancerous condition, and in extreme cases, cancer of the esophagus.
AHRQ also found that:
-- Hospitalizations specifically for GERD increased roughly 5 percent, as a whole, during the period from roughly 91,000 to 95,000.
-- Among these, admissions of patients who had severe symptoms, such as anemia, vomiting and weight loss, increased by 39 percent. Hospitalizations for patients with less serious symptoms, such as hoarseness and chronic coughing, bloating, or belching, rose 43 percent.
-- Hospitalizations for GERD in children ages 2 to 17 rose by 84 percent during the period, and 42 percent for infants under age 2.
This AHRQ News and Numbers is based on data in "Gastroesophageal Reflux Disease (GERD) Hospitalizations in 1998 and 2005". The report uses statistics from the Nationwide Inpatient Sample, a database of hospital inpatient stays that is nationally representative of inpatient stays in all short-term, non-Federal hospitals. The data are drawn from hospitals that comprise 90 percent of all discharges in the United States and include all patients, regardless of insurance type, as well as the uninsured.
Agency for Healthcare Research and Quality (AHRQ)
540 Gaither Rd.
Rockville, MD 20850
United States
Does The Doctor Assess Your Heartburn Correctly?
A simple scale (None, Mild, Moderate, Severe) is frequently used to grade heartburn severity in clinical trials as well as in clinical practice and the question is whether this scale captures the heartburn severity well enough.
In a recent study, "Validation of a 4-Graded Scale for Severity of Heartburn In Patients with Symptoms of Gastroesophageal Reflux Disease", published in Value in Health, the scale was examined to see whether it stands up to established criteria for a functional scale. The study was co-authored by Ola Junghard and Ingela Wiklund (now GSK, UK) of AstaZeneca R&D, Mölndal.
The examination indicates that in terms of the criteria validity, reliability and responsiveness, the scale works well, both when used by the doctor to assess heartburn severity retrospectively, and when used by the patient to record the severity in daily diary cards. The study is based on data from clinical trials in patients with heartburn but without esophagitis.
It is estimated that at least 10% of Western population have symptoms of gastroesophageal reflux disease (Dent et al, GUT 2005;54(5)).
Dr. Junghard comments "Although this scale has been used in clinical trials in gastroesophageal reflux disease for more than 10 years, it has not been validated before. In light of the increasing focus on patient reported outcomes, the evaluation of patient diary card data is of particular interest."
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 3,000 clinicians, decision-makers, and researchers worldwide.
ISPOR is a nonprofit, international organization that strives to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care resources wisely, fairly, and efficiently.
In a recent study, "Validation of a 4-Graded Scale for Severity of Heartburn In Patients with Symptoms of Gastroesophageal Reflux Disease", published in Value in Health, the scale was examined to see whether it stands up to established criteria for a functional scale. The study was co-authored by Ola Junghard and Ingela Wiklund (now GSK, UK) of AstaZeneca R&D, Mölndal.
The examination indicates that in terms of the criteria validity, reliability and responsiveness, the scale works well, both when used by the doctor to assess heartburn severity retrospectively, and when used by the patient to record the severity in daily diary cards. The study is based on data from clinical trials in patients with heartburn but without esophagitis.
It is estimated that at least 10% of Western population have symptoms of gastroesophageal reflux disease (Dent et al, GUT 2005;54(5)).
Dr. Junghard comments "Although this scale has been used in clinical trials in gastroesophageal reflux disease for more than 10 years, it has not been validated before. In light of the increasing focus on patient reported outcomes, the evaluation of patient diary card data is of particular interest."
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 3,000 clinicians, decision-makers, and researchers worldwide.
ISPOR is a nonprofit, international organization that strives to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care resources wisely, fairly, and efficiently.
Does The Doctor Assess Your Heartburn Correctly?
A simple scale (None, Mild, Moderate, Severe) is frequently used to grade heartburn severity in clinical trials as well as in clinical practice and the question is whether this scale captures the heartburn severity well enough.
In a recent study, "Validation of a 4-Graded Scale for Severity of Heartburn In Patients with Symptoms of Gastroesophageal Reflux Disease", published in Value in Health, the scale was examined to see whether it stands up to established criteria for a functional scale. The study was co-authored by Ola Junghard and Ingela Wiklund (now GSK, UK) of AstaZeneca R&D, Mölndal.
The examination indicates that in terms of the criteria validity, reliability and responsiveness, the scale works well, both when used by the doctor to assess heartburn severity retrospectively, and when used by the patient to record the severity in daily diary cards. The study is based on data from clinical trials in patients with heartburn but without esophagitis.
It is estimated that at least 10% of Western population have symptoms of gastroesophageal reflux disease (Dent et al, GUT 2005;54(5)).
Dr. Junghard comments "Although this scale has been used in clinical trials in gastroesophageal reflux disease for more than 10 years, it has not been validated before. In light of the increasing focus on patient reported outcomes, the evaluation of patient diary card data is of particular interest."
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 3,000 clinicians, decision-makers, and researchers worldwide.
ISPOR is a nonprofit, international organization that strives to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care resources wisely, fairly, and efficiently.
In a recent study, "Validation of a 4-Graded Scale for Severity of Heartburn In Patients with Symptoms of Gastroesophageal Reflux Disease", published in Value in Health, the scale was examined to see whether it stands up to established criteria for a functional scale. The study was co-authored by Ola Junghard and Ingela Wiklund (now GSK, UK) of AstaZeneca R&D, Mölndal.
The examination indicates that in terms of the criteria validity, reliability and responsiveness, the scale works well, both when used by the doctor to assess heartburn severity retrospectively, and when used by the patient to record the severity in daily diary cards. The study is based on data from clinical trials in patients with heartburn but without esophagitis.
It is estimated that at least 10% of Western population have symptoms of gastroesophageal reflux disease (Dent et al, GUT 2005;54(5)).
Dr. Junghard comments "Although this scale has been used in clinical trials in gastroesophageal reflux disease for more than 10 years, it has not been validated before. In light of the increasing focus on patient reported outcomes, the evaluation of patient diary card data is of particular interest."
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 3,000 clinicians, decision-makers, and researchers worldwide.
ISPOR is a nonprofit, international organization that strives to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care resources wisely, fairly, and efficiently.
Heartburn Surgery Done Through Patient's Mouth
If you're constantly reaching for antacids to control your heartburn, you may have a more serious problem called reflux disease. Some 25 million Americans have it* and now they have a new option to treat it. Using a newly-approved device for the first time in the U.S., doctors have performed surgery to fix reflux problems without making a single incision.
Developing the technology took decades, but the operation only took an hour. When it was over, doctors at Ohio State University Medical Center may have ushered in a new era of surgery when it comes to fixing reflux problems. Experts at OSUMC say they're the first in the U.S. to use recently approved remote control instruments to repair the valve between the esophagus and stomach without using a scalpel.
"This device eliminates the need for any incisions whatsoever. The entire reconstruction, or rebuilding of the valve, can be done from the inside all with an instrument through the mouth," says Scott Melvin, MD, at Ohio State University Medical Center.
By going entirely through a patient's mouth, doctors don't have to cut into the body. That can dramatically cut down on recovery time and the risk of complications. Gertrude Green was one of the first patients in the country to try the procedure, after 20 years of trying nearly everything else to control her reflux.
"Over the last 20 years I've taken over-the-counter medications, prescriptions and seen more than one doctor," says Green.
Gertrude has known for years that surgery was an option, but in the past, it was more invasive and would require more time to recover. Now this new technique can change that and possibly more.
"Reflux can give people heartburn, but it also has been associated with an increased risk of esophageal cancer. Right now in North America, esophageal cancer has increased dramatically over the last decade - doubling even tripling the number of cases," says Melvin.
It's too early to tell if this surgery will impact the number of cancer cases, but it's clear to patients like Gertrude that it's already addressed the burning issue of reflux.
Doctors say getting heartburn once in a while is normal. If you get it 3 or 4 times a week, you should get it checked. Right now, through-the-mouth surgery is only available at certain hospitals. It is expected to become more common in the coming years.
Developing the technology took decades, but the operation only took an hour. When it was over, doctors at Ohio State University Medical Center may have ushered in a new era of surgery when it comes to fixing reflux problems. Experts at OSUMC say they're the first in the U.S. to use recently approved remote control instruments to repair the valve between the esophagus and stomach without using a scalpel.
"This device eliminates the need for any incisions whatsoever. The entire reconstruction, or rebuilding of the valve, can be done from the inside all with an instrument through the mouth," says Scott Melvin, MD, at Ohio State University Medical Center.
By going entirely through a patient's mouth, doctors don't have to cut into the body. That can dramatically cut down on recovery time and the risk of complications. Gertrude Green was one of the first patients in the country to try the procedure, after 20 years of trying nearly everything else to control her reflux.
"Over the last 20 years I've taken over-the-counter medications, prescriptions and seen more than one doctor," says Green.
Gertrude has known for years that surgery was an option, but in the past, it was more invasive and would require more time to recover. Now this new technique can change that and possibly more.
"Reflux can give people heartburn, but it also has been associated with an increased risk of esophageal cancer. Right now in North America, esophageal cancer has increased dramatically over the last decade - doubling even tripling the number of cases," says Melvin.
It's too early to tell if this surgery will impact the number of cancer cases, but it's clear to patients like Gertrude that it's already addressed the burning issue of reflux.
Doctors say getting heartburn once in a while is normal. If you get it 3 or 4 times a week, you should get it checked. Right now, through-the-mouth surgery is only available at certain hospitals. It is expected to become more common in the coming years.
Patients Encouraged To See A Physician If They Experience Symptoms Suggestive Of GERD
A recent study from the Agency for Healthcare Research and Quality shows that hospitalizations for disorders caused by gastroesophageal reflux disease or GERD rose 103 percent between 1998 and 2005. Also, hospitalizations for patients who had milder forms of GERD (in addition to the condition for which they were admitted), rose by 216 percent during the same time period. The numbers underscore the importance of seeing a physician if symptoms suggestive of GERD are present.
Gastroesophageal reflux is a normal physiologic event, which occurs in all individuals. When this occurs frequently, however, and an individual develops recurrent symptoms and/or complications, then this is considered gastroesophageal reflux disease (GERD). It is estimated that GERD affects up to 30 million people in the U.S., with 10 percent of those individuals experiencing symptoms on a daily basis.
"If you suspect you or a loved one may have GERD, the first step is to consult your healthcare provider or a gastrointestinal specialist to obtain an accurate diagnosis," said Grace H. Elta, MD, FASGE, president of the American Society for Gastrointestinal Endoscopy (ASGE). "GERD is very common. Classic symptoms include heartburn and regurgitation. Work in partnership with your physician to initiate the best available treatment plan and avoid emergency trips to the hospital."
The study suggests that one of the factors leading to the increase in GERD hospitalizations may be the obesity epidemic, since obesity has been linked to GERD. The study also notes that across age groups, the elderly accounted for roughly 30 percent of hospitalizations with a primary GERD diagnosis, and 50 percent of all GERD diagnoses in both 1998 and 2005. The largest increase in discharges with any primary or secondary GERD diagnosis between 1998 and 2005 was for patients age 18 to 34, increasing at a rate of 273 percent. This age group, however, also had the steepest decline in primary GERD diagnosis, down 16 percent. GERD hospital stays occurred more among women than men.
The most typical symptoms of GERD are heartburn and regurgitation. Contents of the stomach, including acid, reflux (move back up) into the esophagus, which may result in uncomfortable symptoms as well as damage to the lining of the esophagus. Individuals with these symptoms are straightforward in their diagnosis. Symptoms, however, may be varied, including, but not limited to: chest discomfort (often difficult to discern from cardiac-related pain), asthma, cough, nausea, bad breath and loss of tooth enamel.
Complications of acid reflux can include dysphagia (difficulty swallowing), regurgitation, and an increased risk of esophageal cancer. This is due to progressive damage to the esophagus, resulting in inflammation, ulceration and possible scarring with narrowing. In addition, these symptoms may be indicative of esophageal cancer. All of these symptoms merit seeing a doctor for further care. At that time, the physician may perform an upper endoscopy to evaluate the source of the problem.
In some cases, individuals can alter their diet and take over-the-counter antacids to reduce symptoms. Dietary changes include avoiding acidic foods, fat-laden foods and overeating. Specific foods, such as chocolate, peppermints and tomato products, can exacerbate symptoms. Other lifestyle measures, such as losing weight, reducing or eliminating smoking and alcohol consumption, not eating late at night and elevating the head of the bed, may be helpful as well. Obesity is strongly associated with both GERD and its complications.
Some individuals may be on medications that promote acid reflux, such as calcium channel blockers and nitrates. These medications, however, should not be stopped by the patient without consultation from their doctor.
For individuals who do not have adequate symptom improvement with lifestyle alterations, medications may be necessary. These include histamine2-receptor antagonists (H2RAs), proton pump inhibitors (PPIs) and prokinetic agents. Although H2RAs and PPIs are available over the counter, patients who have frequent GERD symptoms or use these OTC medications regularly should see a physician.
Surgical therapy is available for those who do not respond to lifestyle and medication therapy or who do not wish to remain on medications. Surgery consists of wrapping the top of the stomach to reform the natural acid barrier and fixing the defect in the diaphragm and hiatal hernia if present. Surgical therapy is --at least over the short term -- equivalent to medical therapy. The decision of medical versus surgical therapy depends on how well the patient would tolerate surgery, their response to medical therapy and the underlying causes of the GERD. In addition, there are several endoscopic treatments for GERD. However, these are still relatively new and, for the most part, unproven or still investigational.
Do you have GERD?
If you can answer "yes" to two or more of the following questions, you may have GERD.
Do you frequently have one or more of the following?
* An uncomfortable feeling behind the breastbone that seems to be moving upward from the stomach?
* A burning sensation in the back of your throat?
* A bitter acid taste in your mouth?
* Do you often experience these problems after meals?
* Do you experience heartburn or acid indigestion two or more times per week?
* Do you find that antacids only provide temporary relief from your symptoms?
* Are you taking prescription medication to treat heartburn, but still having symptoms?
Seek diagnosis and treatment if symptoms occur on a regular basis. Your GI specialist can help you enjoy every day by defining your discomfort and providing treatment designed for you. To find a gastrointestinal endoscopist in your area who can diagnose and treat you or a loved one
Gastroesophageal reflux is a normal physiologic event, which occurs in all individuals. When this occurs frequently, however, and an individual develops recurrent symptoms and/or complications, then this is considered gastroesophageal reflux disease (GERD). It is estimated that GERD affects up to 30 million people in the U.S., with 10 percent of those individuals experiencing symptoms on a daily basis.
"If you suspect you or a loved one may have GERD, the first step is to consult your healthcare provider or a gastrointestinal specialist to obtain an accurate diagnosis," said Grace H. Elta, MD, FASGE, president of the American Society for Gastrointestinal Endoscopy (ASGE). "GERD is very common. Classic symptoms include heartburn and regurgitation. Work in partnership with your physician to initiate the best available treatment plan and avoid emergency trips to the hospital."
The study suggests that one of the factors leading to the increase in GERD hospitalizations may be the obesity epidemic, since obesity has been linked to GERD. The study also notes that across age groups, the elderly accounted for roughly 30 percent of hospitalizations with a primary GERD diagnosis, and 50 percent of all GERD diagnoses in both 1998 and 2005. The largest increase in discharges with any primary or secondary GERD diagnosis between 1998 and 2005 was for patients age 18 to 34, increasing at a rate of 273 percent. This age group, however, also had the steepest decline in primary GERD diagnosis, down 16 percent. GERD hospital stays occurred more among women than men.
The most typical symptoms of GERD are heartburn and regurgitation. Contents of the stomach, including acid, reflux (move back up) into the esophagus, which may result in uncomfortable symptoms as well as damage to the lining of the esophagus. Individuals with these symptoms are straightforward in their diagnosis. Symptoms, however, may be varied, including, but not limited to: chest discomfort (often difficult to discern from cardiac-related pain), asthma, cough, nausea, bad breath and loss of tooth enamel.
Complications of acid reflux can include dysphagia (difficulty swallowing), regurgitation, and an increased risk of esophageal cancer. This is due to progressive damage to the esophagus, resulting in inflammation, ulceration and possible scarring with narrowing. In addition, these symptoms may be indicative of esophageal cancer. All of these symptoms merit seeing a doctor for further care. At that time, the physician may perform an upper endoscopy to evaluate the source of the problem.
In some cases, individuals can alter their diet and take over-the-counter antacids to reduce symptoms. Dietary changes include avoiding acidic foods, fat-laden foods and overeating. Specific foods, such as chocolate, peppermints and tomato products, can exacerbate symptoms. Other lifestyle measures, such as losing weight, reducing or eliminating smoking and alcohol consumption, not eating late at night and elevating the head of the bed, may be helpful as well. Obesity is strongly associated with both GERD and its complications.
Some individuals may be on medications that promote acid reflux, such as calcium channel blockers and nitrates. These medications, however, should not be stopped by the patient without consultation from their doctor.
For individuals who do not have adequate symptom improvement with lifestyle alterations, medications may be necessary. These include histamine2-receptor antagonists (H2RAs), proton pump inhibitors (PPIs) and prokinetic agents. Although H2RAs and PPIs are available over the counter, patients who have frequent GERD symptoms or use these OTC medications regularly should see a physician.
Surgical therapy is available for those who do not respond to lifestyle and medication therapy or who do not wish to remain on medications. Surgery consists of wrapping the top of the stomach to reform the natural acid barrier and fixing the defect in the diaphragm and hiatal hernia if present. Surgical therapy is --at least over the short term -- equivalent to medical therapy. The decision of medical versus surgical therapy depends on how well the patient would tolerate surgery, their response to medical therapy and the underlying causes of the GERD. In addition, there are several endoscopic treatments for GERD. However, these are still relatively new and, for the most part, unproven or still investigational.
Do you have GERD?
If you can answer "yes" to two or more of the following questions, you may have GERD.
Do you frequently have one or more of the following?
* An uncomfortable feeling behind the breastbone that seems to be moving upward from the stomach?
* A burning sensation in the back of your throat?
* A bitter acid taste in your mouth?
* Do you often experience these problems after meals?
* Do you experience heartburn or acid indigestion two or more times per week?
* Do you find that antacids only provide temporary relief from your symptoms?
* Are you taking prescription medication to treat heartburn, but still having symptoms?
Seek diagnosis and treatment if symptoms occur on a regular basis. Your GI specialist can help you enjoy every day by defining your discomfort and providing treatment designed for you. To find a gastrointestinal endoscopist in your area who can diagnose and treat you or a loved one
Black Raspberries Protect Against Cancer - New Study Finds Black Raspberries Help Barrett's Esophagus Patients
It usually starts as reflux, but for 700 thousand Americans, it turns into something called Barrett's Esophagus.* Now the black raspberry may be one of the weapons Barrett's Esophagus patients have to stay strong and prevent the condition from turning into a deadly cancer.
For more than 10 years, Danny Harris has struggled with heartburn after he eats. He learned his reflux has turned into something more serious - a condition called Barrett's Esophagus. He also learned an interesting thing happened when he ate black raspberries.
"I really didn't have any flare-ups or episodes after I had taken the berries," says Harris.
Danny was part of a new study, led by a research team at Ohio State University's Comprehensive Cancer Center. For six months he and other Barrett's Esophagus patients drank a black raspberry powder and water mix. Turns out, the fruit helped many patients reverse the negative impact of the reflux acid. Nearly 4 in 10 saw a boost in a protective enzyme and 6 in 10 saw a decline in oxidative stress, which can cause cell damage.
"If we can feed something in the diet that may help us protect against these injurious agents, then that may potentially impact progression of this disease," says Laura Kresty, PhD at Ohio State University's Comprehensive Cancer Center.
That's important because 1 in 10 people with Barrett's Esophagus develops a deadly cancer of the esophagus. Researchers believe the fruit's combination of nutrients gives it super healing power.
"They're really strong antioxidants. They're also a good source of multi-vitamins and minerals," says Kresty.
A larger study is likely the next step to see if black raspberries yield more positive results for patients with Barrett's Esophagus.
For more than 10 years, Danny Harris has struggled with heartburn after he eats. He learned his reflux has turned into something more serious - a condition called Barrett's Esophagus. He also learned an interesting thing happened when he ate black raspberries.
"I really didn't have any flare-ups or episodes after I had taken the berries," says Harris.
Danny was part of a new study, led by a research team at Ohio State University's Comprehensive Cancer Center. For six months he and other Barrett's Esophagus patients drank a black raspberry powder and water mix. Turns out, the fruit helped many patients reverse the negative impact of the reflux acid. Nearly 4 in 10 saw a boost in a protective enzyme and 6 in 10 saw a decline in oxidative stress, which can cause cell damage.
"If we can feed something in the diet that may help us protect against these injurious agents, then that may potentially impact progression of this disease," says Laura Kresty, PhD at Ohio State University's Comprehensive Cancer Center.
That's important because 1 in 10 people with Barrett's Esophagus develops a deadly cancer of the esophagus. Researchers believe the fruit's combination of nutrients gives it super healing power.
"They're really strong antioxidants. They're also a good source of multi-vitamins and minerals," says Kresty.
A larger study is likely the next step to see if black raspberries yield more positive results for patients with Barrett's Esophagus.
EndoGastric Solutions(TM) Announces Results Of EsophyX(TM) Multi-Center GERD Study
EndoGastric Solutions, the world leader in natural orifice surgery products and procedures, announces outstanding results at the completion of 1-year follow-up on GERD patients in the phase 2 multi-center study of the first generation transoral incisionless fundoplication (TIF 1) procedure and first-generation EsophyX device. EndoGastric Solutions is the first company to successfully design truly incisionless transoral surgical products that mimic the outcomes of the more invasive gold-standard antireflux surgeries, laparoscopic fundoplications (i.e. Nissen, Toupet or Hill procedures). The EsophyX device enables surgeons and advanced interventional gastroenterologists to offer their patients substantive anatomical repair without incisions (no skin or internal dissection) for front-line surgical management of gastroesophageal reflux disease (GERD) patients.
Dr. John Hunter, Professor and Chairman of the Department of Surgery at Oregon Health & Science University in Portland, Oregon, states, "For years, the medical community has been looking for less invasive ways to treat GERD patients to reduce their dependence on pharmaceuticals. Our department has studied the effects of these pharmaceuticals and is concerned that there are additional detrimental effects that should be avoided. EsophyX is an impressive technology with impressive results that advances the treatment of GERD a giant leap forward."
Dr. Todd Overcash, Medical Director of Bariatric and Minimally Invasive Surgery at Munroe Regional Medical Center in Ocala, Florida, is the United States leader of NOS (Natural Orifice Surgery) procedures performed. He was among the first U.S. surgical teams that went to Europe last fall to train on this new technique. He has now performed more EsophyX procedures than any surgeon in the U.S. and states: "Having performed 38 advanced TIF procedures with the EsophyX device in the last three months, I can attest that this incisionless technique offers our patients a tremendous improvement in their quality of life. It allows them the ability to eat foods and beverages they could not tolerate before the procedure but, most importantly, it allows them to discontinue their use of GERD medications in the majority of cases, which is especially important for women in the face of osteoporosis. With no skin incisions, no cutting of vessels, and no dissection of the fundus, the EsophyX device represents a new era in antireflux treatment and offers patients an innovative, state-of-the-art surgical procedure that will allow them to no longer live their lives pill-to-pill."
Dr. Scott Melvin, Professor of Surgery, Director of the Center for Minimally Invasive Surgery and Chief of the Division of General & Gastrointestinal Surgery at The Ohio State University (OSU) Medical Center, will be demonstrating this new TIF technique at a live case course at OSU February 29th: "I am very impressed with the clinical results for EsophyX, including the reduction/elimination of hiatal hernia and reduction/elimination of esophagitis. These multi-center study results confirm the 2 year outcomes seen in the first EsophyX study. With over 750 Natural Orifice Surgical cases performed to date, utilizing EndoGastric Solutions technology platforms, it is clear that TIF is a mainstream procedure that most advanced foregut surgeons should be incorporating into their clinical practice. Any surgeon considering being a natural orifice surgeon should come see the techniques and learn more at our course."
"We are very pleased with the outstanding results of our first two GERD clinical studies," states Thierry Thaure, CEO of EndoGastric Solutions (EGS) Inc. "These results were achieved with the first version of the EsophyX device and TIF 1 procedure. We believe in continuous improvement and are already teaching a much improved TIF 2 technique in our training center in Redmond, Washington that has shown even stronger outcomes. We are encouraged that surgeons and advanced surgical endoscopists are rapidly adopting these new incisionless procedures, as patients are demanding a permanent solution for their reflux disease in the face of failing pharmacological therapy."
About EndoGastric Solutions
EndoGastric Solutions (EGS) is a privately held corporation located in Redmond, Washington and Redwood City, California. EGS is a pioneer in developing incisionless transoral procedures for the treatment of upper gastrointestinal diseases, including gastroesophageal reflux disease (GERD) and other GI conditions. EsophyX and StomaphyX(TM) are cleared by the FDA for specific indications, are CE marked, and are available for sale in the U.S. and Europe.
Dr. John Hunter, Professor and Chairman of the Department of Surgery at Oregon Health & Science University in Portland, Oregon, states, "For years, the medical community has been looking for less invasive ways to treat GERD patients to reduce their dependence on pharmaceuticals. Our department has studied the effects of these pharmaceuticals and is concerned that there are additional detrimental effects that should be avoided. EsophyX is an impressive technology with impressive results that advances the treatment of GERD a giant leap forward."
Dr. Todd Overcash, Medical Director of Bariatric and Minimally Invasive Surgery at Munroe Regional Medical Center in Ocala, Florida, is the United States leader of NOS (Natural Orifice Surgery) procedures performed. He was among the first U.S. surgical teams that went to Europe last fall to train on this new technique. He has now performed more EsophyX procedures than any surgeon in the U.S. and states: "Having performed 38 advanced TIF procedures with the EsophyX device in the last three months, I can attest that this incisionless technique offers our patients a tremendous improvement in their quality of life. It allows them the ability to eat foods and beverages they could not tolerate before the procedure but, most importantly, it allows them to discontinue their use of GERD medications in the majority of cases, which is especially important for women in the face of osteoporosis. With no skin incisions, no cutting of vessels, and no dissection of the fundus, the EsophyX device represents a new era in antireflux treatment and offers patients an innovative, state-of-the-art surgical procedure that will allow them to no longer live their lives pill-to-pill."
Dr. Scott Melvin, Professor of Surgery, Director of the Center for Minimally Invasive Surgery and Chief of the Division of General & Gastrointestinal Surgery at The Ohio State University (OSU) Medical Center, will be demonstrating this new TIF technique at a live case course at OSU February 29th: "I am very impressed with the clinical results for EsophyX, including the reduction/elimination of hiatal hernia and reduction/elimination of esophagitis. These multi-center study results confirm the 2 year outcomes seen in the first EsophyX study. With over 750 Natural Orifice Surgical cases performed to date, utilizing EndoGastric Solutions technology platforms, it is clear that TIF is a mainstream procedure that most advanced foregut surgeons should be incorporating into their clinical practice. Any surgeon considering being a natural orifice surgeon should come see the techniques and learn more at our course."
"We are very pleased with the outstanding results of our first two GERD clinical studies," states Thierry Thaure, CEO of EndoGastric Solutions (EGS) Inc. "These results were achieved with the first version of the EsophyX device and TIF 1 procedure. We believe in continuous improvement and are already teaching a much improved TIF 2 technique in our training center in Redmond, Washington that has shown even stronger outcomes. We are encouraged that surgeons and advanced surgical endoscopists are rapidly adopting these new incisionless procedures, as patients are demanding a permanent solution for their reflux disease in the face of failing pharmacological therapy."
About EndoGastric Solutions
EndoGastric Solutions (EGS) is a privately held corporation located in Redmond, Washington and Redwood City, California. EGS is a pioneer in developing incisionless transoral procedures for the treatment of upper gastrointestinal diseases, including gastroesophageal reflux disease (GERD) and other GI conditions. EsophyX and StomaphyX(TM) are cleared by the FDA for specific indications, are CE marked, and are available for sale in the U.S. and Europe.
New Advice On Treating GERD: Johns Hopkins Health Alerts Reports On The Latest Research
Johns Hopkins Health Alerts has just published a review of the new GERD guidelines, for safe, effective treatment of your acid reflux.
Treating GERD Effectively
There are four types of treatments for gastroesophageal reflux disease (GERD): lifestyle measures, medication, surgery, and endoscopic procedures.
Why it is important to treat GERD
Treating GERD is important. Untreated GERD can lead to serious complications, such as esophageal ulcers (nonhealing mucosal defects), esophageal strictures, Barrett's esophagus (a disorder of the cells lining the esophageal mucosa, which may lead to cancer), and even esophageal cancer.
Lifestyle changes to treat GERD
Doctors often recommend lifestyle changes as the first-line treatment for acid reflux. These measures can include elevating the head of the bed during sleep, not eating late at night, and avoiding alcohol or spicy foods.
New findings on effective treatments for GERD
However, a new study reported in "The Archives of Internal Medicine" (Volume 166, page 965) shows that NOT ALL of these changes are helpful in relieving GERD symptoms, and some may be unnecessarily restrictive.
Researchers looked at the results of 100 studies conducted on various lifestyle measures for GERD. Only losing weight and elevating the head of the bed showed a CLEAR BENEFIT in well-designed studies.
Other measures not found to be effective
In comparison, there was little evidence to support avoiding many suspected GERD triggers, such as alcohol, caffeine, chocolate, spicy foods, citrus, carbonated beverages, fatty foods, and mint. The same was true for sleeping on your left side or avoiding food late at night.
Although there was evidence that some of these substances and practices can cause GERD symptoms, evidence was lacking that avoiding them will relieve symptoms.
Bottom line advice on treating GERD
However, if you experience worsening GERD symptoms after eating certain foods or drinking specific beverages you should probably avoid them. In addition, you should certainly give lifestyle changes a chance before trying medication to relieve your GERD symptoms.
For the latest health alerts on GERD (acid reflux), sour stomach, and other digestive disorders, please visit the Johns Hopkins Health Alerts Digestive Disorders Topic Page at: Johns Hopkins Health Alerts Digestive Disorders
This article is exceprted from the annual Johns Hopkins White Paper: Digestive Disorders. For more information about this book, please visit: Johns Hopkins White Paper: Digestive Disorders
Johns Hopkins Health Alerts
Treating GERD Effectively
There are four types of treatments for gastroesophageal reflux disease (GERD): lifestyle measures, medication, surgery, and endoscopic procedures.
Why it is important to treat GERD
Treating GERD is important. Untreated GERD can lead to serious complications, such as esophageal ulcers (nonhealing mucosal defects), esophageal strictures, Barrett's esophagus (a disorder of the cells lining the esophageal mucosa, which may lead to cancer), and even esophageal cancer.
Lifestyle changes to treat GERD
Doctors often recommend lifestyle changes as the first-line treatment for acid reflux. These measures can include elevating the head of the bed during sleep, not eating late at night, and avoiding alcohol or spicy foods.
New findings on effective treatments for GERD
However, a new study reported in "The Archives of Internal Medicine" (Volume 166, page 965) shows that NOT ALL of these changes are helpful in relieving GERD symptoms, and some may be unnecessarily restrictive.
Researchers looked at the results of 100 studies conducted on various lifestyle measures for GERD. Only losing weight and elevating the head of the bed showed a CLEAR BENEFIT in well-designed studies.
Other measures not found to be effective
In comparison, there was little evidence to support avoiding many suspected GERD triggers, such as alcohol, caffeine, chocolate, spicy foods, citrus, carbonated beverages, fatty foods, and mint. The same was true for sleeping on your left side or avoiding food late at night.
Although there was evidence that some of these substances and practices can cause GERD symptoms, evidence was lacking that avoiding them will relieve symptoms.
Bottom line advice on treating GERD
However, if you experience worsening GERD symptoms after eating certain foods or drinking specific beverages you should probably avoid them. In addition, you should certainly give lifestyle changes a chance before trying medication to relieve your GERD symptoms.
For the latest health alerts on GERD (acid reflux), sour stomach, and other digestive disorders, please visit the Johns Hopkins Health Alerts Digestive Disorders Topic Page at: Johns Hopkins Health Alerts Digestive Disorders
This article is exceprted from the annual Johns Hopkins White Paper: Digestive Disorders. For more information about this book, please visit: Johns Hopkins White Paper: Digestive Disorders
Johns Hopkins Health Alerts
Orexo Announces Results Confirming The Clinical Profile Of OX17 In Reflux Disease (GERD)
New clinical data from a phase II study confirms the competitive profile of Orexo's product OX17 in GERD patients, i.e. fast, effective and sustained inhibition of gastric acid production, a prerequisite for effective symptom relief in the patient. The result demonstrates the clinical potential of OX17 and is an important step in the development of a competitive product.
GERD, gastroesofageal reflux disease, is a common ailment in the Western world. Orexos product OX17 combines the advantages (rapid onset and sustained duration of effect) of two existing treatments and therefore has the potential to become an important alternative in the treatment of reflux disease. OX17 is a combination of two well-known active substances both inhibiting the secretion of gastric acid; a H2 receptor antagonist (famotidine) and a proton pump inhibitor (omeprazole).
In a controlled clinical trial with 59 GERD patients treated for 14 days, the anti-secretory effect of OX17 was compared to omeprazole and famotidine. The study was performed at Sahlgrenska university hospital in Gothenburg and Berzelius Clinical Research Center in Linköping, Sweden. The primary endpoint was fulfilled: OX17 significantly reduces the acid production compared to omeprazole day 1. The time with pH>4 the first 12 hours after dosing was on average 60% longer with OX17 compared to omeprazole. (p<0.05). After 14 days treatment, the time with gastric pH above 4 was twice as long as after treatment with famotidine. The patients need for rescue medication (antacids) during the 14 day study period was considerably lower for OX17 compared to both famotidine and omeprazole indicating good control of GERD symptoms.
"The results confirm that OX17 has a favorable and unique clinical profile for a drug intended for the treatment of GERD. This is an important strategic step in our OX17-project, which further increases the project's commercial value. In 2006, the combined market for H2 receptor antagonists and proton pump inhibitors amounted to some USD 27 bn", said Torbjörn Bjerke, President and CEO of Orexo.
About Orexo
Orexo is a specialty pharmaceutical company, focusing on development of new, patented drugs by combining well-documented substances with innovative technologies, and the development of new treatments for respiratory and inflammatory diseases.
Orexo has a broad and competitive late-stage product portfolio, including two marketed products, five products in clinical phase and two undergoing registration.
To date, Orexo have out-licensed the market rights for Rapinyl for the US, the EU and Japan markets, and signed a research collaboration with Boehringer Ingelheim regarding the development of a new class of drugs to treat pain and inflammation. Also, Orexo has established a Nordic sales force by entering into a joint venture with ProStrakan.
Orexo has head office in Uppsala and is listed on the OMX Nordic Exchange Stockholm, Small Cap (ticker: ORX).
GERD, gastroesofageal reflux disease, is a common ailment in the Western world. Orexos product OX17 combines the advantages (rapid onset and sustained duration of effect) of two existing treatments and therefore has the potential to become an important alternative in the treatment of reflux disease. OX17 is a combination of two well-known active substances both inhibiting the secretion of gastric acid; a H2 receptor antagonist (famotidine) and a proton pump inhibitor (omeprazole).
In a controlled clinical trial with 59 GERD patients treated for 14 days, the anti-secretory effect of OX17 was compared to omeprazole and famotidine. The study was performed at Sahlgrenska university hospital in Gothenburg and Berzelius Clinical Research Center in Linköping, Sweden. The primary endpoint was fulfilled: OX17 significantly reduces the acid production compared to omeprazole day 1. The time with pH>4 the first 12 hours after dosing was on average 60% longer with OX17 compared to omeprazole. (p<0.05). After 14 days treatment, the time with gastric pH above 4 was twice as long as after treatment with famotidine. The patients need for rescue medication (antacids) during the 14 day study period was considerably lower for OX17 compared to both famotidine and omeprazole indicating good control of GERD symptoms.
"The results confirm that OX17 has a favorable and unique clinical profile for a drug intended for the treatment of GERD. This is an important strategic step in our OX17-project, which further increases the project's commercial value. In 2006, the combined market for H2 receptor antagonists and proton pump inhibitors amounted to some USD 27 bn", said Torbjörn Bjerke, President and CEO of Orexo.
About Orexo
Orexo is a specialty pharmaceutical company, focusing on development of new, patented drugs by combining well-documented substances with innovative technologies, and the development of new treatments for respiratory and inflammatory diseases.
Orexo has a broad and competitive late-stage product portfolio, including two marketed products, five products in clinical phase and two undergoing registration.
To date, Orexo have out-licensed the market rights for Rapinyl for the US, the EU and Japan markets, and signed a research collaboration with Boehringer Ingelheim regarding the development of a new class of drugs to treat pain and inflammation. Also, Orexo has established a Nordic sales force by entering into a joint venture with ProStrakan.
Orexo has head office in Uppsala and is listed on the OMX Nordic Exchange Stockholm, Small Cap (ticker: ORX).
Recurring Symptoms Experienced By Nearly 40 Percent Of GERD Patients Taking PPIs
Despite daily use of doctor-recommended proton pump inhibitors (PPIs) to control gastroesophageal reflux disease (GERD) symptoms, nearly 40 percent of patients who take them continue to experience breakthrough, which is a return of GERD symptoms, such as acid regurgitation and heartburn. These breakthrough symptoms lead more than half of GERD sufferers to use over-the-counter (OTC) remedies, according to a survey recently conducted by the American Gastroenterological Association (AGA) Institute.
The survey of 1,064 people with GERD found that approximately 56 percent of those who experienced breakthrough used an OTC treatment - the majority using an antacid - to manage breakthrough symptoms. Further, taking an OTC in addition to a PPI has become routine for these respondents. In fact, more than 70 percent have been using OTC medications for at least one year.
"The survey results show that people with GERD are not only using their prescribed PPI, but also are turning to over-the-counter remedies as a stop-gap when they have breakthrough symptoms," said John Inadomi, MD, associate professor of medicine, University of California, San Francisco.
Additional survey findings showed that:
* More than 40 percent of respondents on a PPI who experience breakthrough symptoms, report those symptoms occur two to four times per week.
* Respondents report breakthrough symptoms occur throughout the day, sometimes multiple times per day. Sixty-five percent of GERD sufferers experienced breakthrough at night and 28 percent report sleep disruption because of their symptoms.
* Among patients suffering from breakthrough symptoms, at least 50 percent are not fully satisfied with the specific symptom relief (e.g., acid regurgitation and heartburn) they get from their once-daily PPI.
* While 98 percent of respondents who experience breakthrough symptoms report taking their PPI as directed, more than 40 percent have not spoken to their physician about these symptoms.
* Nearly two-thirds (57 percent) of respondents report that their physician has not asked about their habitual use of OTC medications, such as Alka-Seltzer, Mylanta, Pepcid Complete and Pepto-Bismol, in addition to their PPI.
"Breakthrough symptoms can be bothersome and frustrating to GERD sufferers, but they aren't talking about it with their physician as often as they should," said Dr. Inadomi. "By discussing the frequency, severity and timing of breakthrough symptoms, physicians and patients can determine if changes need to be made to their GERD treatment."
About GERD
GERD stands for gastroesophageal reflux disease. It is caused by frequent or regular back up of stomach juices from the stomach into the esophagus. It is estimated that GERD affects between 25-35 percent of the U.S. population. Common symptoms of GERD include: heartburn, dyspepsia, regurgitation, chest sensations or pain, acid laryngitis and dysphagia. Proton pump inhibitors decrease acid production by turning off many of the acid pumps in the stomach.
About the Survey
The survey was conducted by Harris Interactive and funded through a grant by TAP Pharmaceutical Products Inc. The survey consisted of a 10-minute online, self-administered survey. Participants were 40 percent male, 60 percent female. Forty percent of the respondents were under age 49 and 60 percent were 50 and over. All patients suffered from GERD and had been taking a PPI to control their symptoms for at least three months.
The main sample is associated with a margin of sampling error plus or minus 3 percentage points; for results based on subgroups the sampling error is higher. Where comparisons were made, significance testing was done at 95 percent confidence. Testing differences between groups at the 95 percent confidence level indicates that there is no more than a 5 in 100 chance that the difference observed between the groups could have been obtained by chance.
The survey of 1,064 people with GERD found that approximately 56 percent of those who experienced breakthrough used an OTC treatment - the majority using an antacid - to manage breakthrough symptoms. Further, taking an OTC in addition to a PPI has become routine for these respondents. In fact, more than 70 percent have been using OTC medications for at least one year.
"The survey results show that people with GERD are not only using their prescribed PPI, but also are turning to over-the-counter remedies as a stop-gap when they have breakthrough symptoms," said John Inadomi, MD, associate professor of medicine, University of California, San Francisco.
Additional survey findings showed that:
* More than 40 percent of respondents on a PPI who experience breakthrough symptoms, report those symptoms occur two to four times per week.
* Respondents report breakthrough symptoms occur throughout the day, sometimes multiple times per day. Sixty-five percent of GERD sufferers experienced breakthrough at night and 28 percent report sleep disruption because of their symptoms.
* Among patients suffering from breakthrough symptoms, at least 50 percent are not fully satisfied with the specific symptom relief (e.g., acid regurgitation and heartburn) they get from their once-daily PPI.
* While 98 percent of respondents who experience breakthrough symptoms report taking their PPI as directed, more than 40 percent have not spoken to their physician about these symptoms.
* Nearly two-thirds (57 percent) of respondents report that their physician has not asked about their habitual use of OTC medications, such as Alka-Seltzer, Mylanta, Pepcid Complete and Pepto-Bismol, in addition to their PPI.
"Breakthrough symptoms can be bothersome and frustrating to GERD sufferers, but they aren't talking about it with their physician as often as they should," said Dr. Inadomi. "By discussing the frequency, severity and timing of breakthrough symptoms, physicians and patients can determine if changes need to be made to their GERD treatment."
About GERD
GERD stands for gastroesophageal reflux disease. It is caused by frequent or regular back up of stomach juices from the stomach into the esophagus. It is estimated that GERD affects between 25-35 percent of the U.S. population. Common symptoms of GERD include: heartburn, dyspepsia, regurgitation, chest sensations or pain, acid laryngitis and dysphagia. Proton pump inhibitors decrease acid production by turning off many of the acid pumps in the stomach.
About the Survey
The survey was conducted by Harris Interactive and funded through a grant by TAP Pharmaceutical Products Inc. The survey consisted of a 10-minute online, self-administered survey. Participants were 40 percent male, 60 percent female. Forty percent of the respondents were under age 49 and 60 percent were 50 and over. All patients suffered from GERD and had been taking a PPI to control their symptoms for at least three months.
The main sample is associated with a margin of sampling error plus or minus 3 percentage points; for results based on subgroups the sampling error is higher. Where comparisons were made, significance testing was done at 95 percent confidence. Testing differences between groups at the 95 percent confidence level indicates that there is no more than a 5 in 100 chance that the difference observed between the groups could have been obtained by chance.
Researcher Reports On Noninvasive Device For GERD, Obesity
A new, noninvasive gastroplasty device to treat two separate disorders gastroesophageal-reflux disease (GERD) and morbid obesity was reported by its inventor, Charles J. Filipi, M.D., professor of surgery at Creighton University School of Medicine.
Filipi spoke about the device, which could be available for human trials later this year, on Monday, May 19, at the 49th annual Digestive Disease Week in San Diego, Calif. The meeting is considered the largest and most prestigious meeting worldwide on digestive diseases.
"Gastroesophageal-reflux disease and morbid obesity are particularly serious health issues in the western hemisphere and major contributors to the escalating cost of health care in the United States," Filipi said. "We believe that this device will result in much more effective treatments for both conditions, fewer complications and less patient expense, while permitting each procedure to be performed on an outpatient basis."
Typically, operations for GERD or obesity are performed using incisions, which requires hospitalization and have the potential for significant complications, he said. The device, a flexible tube with a metal capsule that is 3-feet-long and less than 4/5 of an inch in diameter avoids the need for incisions, Filipi noted.
To treat obesity, Filipi's device is introduced through the mouth and esophagus, suctioning two sides of the stomach lining into position for suturing, impaling the mucosa (stomach lining), and placing a row of stitches through the stomach's two sides. To assist in healing, part of the inner lining of the stomach is removed, and the remaining areas are brought together by adjacent stitches to form a small stomach "pouch" that accommodates only a few bites of food. Bringing the remaining areas together for healing and scarring increases the strength of the stomach-pouch wall so it will last longer, distinguishing this procedure from other noninvasive methods that have been attempted for obesity and reflux disease.
To treat GERD a condition in which a patient's gastroesophageal junction does not close completely and acid or bile from the stomach enters and can damage the esophagus the device is inserted through the mouth and esophagus until it reaches the esophageal junction, the opening at the bottom of the esophagus that connects the esophagus to the stomach. A surgeon can then use the instrument to suture the esophageal junction to make it smaller. Usually two stitches are necessary on one side of the gastroesophageal junction.
SafeStitch Medical Inc., a publicly traded medical-device company based in Miami, is developing Filipi's device with licensed intellectual property from Creighton University. Filipi is medical director for SafeStitch.
About Creighton University: Creighton (pronounced Cray-ton) University, a comprehensive Jesuit, Catholic institution located in Omaha, Neb., has embarked on the most ambitious fundraising campaign in the school's history with a goal of raising $350 million. The Willing to Lead campaign reflects Creighton's commitment to prepare and inspire tomorrow's leaders. The freshman class profile consistently ranks in the top five among Midwestern universities of our size and the top 10 Catholic universities nationwide. We enroll more than 4,000 undergraduate and 2,900 professional school and graduate students in its College of Arts and Sciences, College of Business Administration, Graduate School, and Schools of Dentistry, Law, Medicine, Nursing and Pharmacy and Health Professions. For more information visit our website at:
Filipi spoke about the device, which could be available for human trials later this year, on Monday, May 19, at the 49th annual Digestive Disease Week in San Diego, Calif. The meeting is considered the largest and most prestigious meeting worldwide on digestive diseases.
"Gastroesophageal-reflux disease and morbid obesity are particularly serious health issues in the western hemisphere and major contributors to the escalating cost of health care in the United States," Filipi said. "We believe that this device will result in much more effective treatments for both conditions, fewer complications and less patient expense, while permitting each procedure to be performed on an outpatient basis."
Typically, operations for GERD or obesity are performed using incisions, which requires hospitalization and have the potential for significant complications, he said. The device, a flexible tube with a metal capsule that is 3-feet-long and less than 4/5 of an inch in diameter avoids the need for incisions, Filipi noted.
To treat obesity, Filipi's device is introduced through the mouth and esophagus, suctioning two sides of the stomach lining into position for suturing, impaling the mucosa (stomach lining), and placing a row of stitches through the stomach's two sides. To assist in healing, part of the inner lining of the stomach is removed, and the remaining areas are brought together by adjacent stitches to form a small stomach "pouch" that accommodates only a few bites of food. Bringing the remaining areas together for healing and scarring increases the strength of the stomach-pouch wall so it will last longer, distinguishing this procedure from other noninvasive methods that have been attempted for obesity and reflux disease.
To treat GERD a condition in which a patient's gastroesophageal junction does not close completely and acid or bile from the stomach enters and can damage the esophagus the device is inserted through the mouth and esophagus until it reaches the esophageal junction, the opening at the bottom of the esophagus that connects the esophagus to the stomach. A surgeon can then use the instrument to suture the esophageal junction to make it smaller. Usually two stitches are necessary on one side of the gastroesophageal junction.
SafeStitch Medical Inc., a publicly traded medical-device company based in Miami, is developing Filipi's device with licensed intellectual property from Creighton University. Filipi is medical director for SafeStitch.
About Creighton University: Creighton (pronounced Cray-ton) University, a comprehensive Jesuit, Catholic institution located in Omaha, Neb., has embarked on the most ambitious fundraising campaign in the school's history with a goal of raising $350 million. The Willing to Lead campaign reflects Creighton's commitment to prepare and inspire tomorrow's leaders. The freshman class profile consistently ranks in the top five among Midwestern universities of our size and the top 10 Catholic universities nationwide. We enroll more than 4,000 undergraduate and 2,900 professional school and graduate students in its College of Arts and Sciences, College of Business Administration, Graduate School, and Schools of Dentistry, Law, Medicine, Nursing and Pharmacy and Health Professions. For more information visit our website at:
Dysplasia In Barrett's Esophagus Treated Effectively By Radiofrequency Ablation
Interim results from a nationwide clinical trial led by a University of North Carolina at Chapel Hill researcher suggest that radiofrequency ablation is an effective treatment for dysplasia in people with Barrett's esophagus, a condition that can lead to deadly gastrointestinal cancer.
"The interim results show there is a substantial difference between treatment with radiofrequency ablation and a placebo or 'sham' treatment," said Dr. Nicholas Shaheen, principal investigator of the study and director of UNC's Center for Esophageal Diseases and Swallowing. "It's a strongly positive finding."
Shaheen, who is also an associate professor of medicine and epidemiology in UNC's Schools of Medicine and Public Health, presented the results Monday, May 19 at the annual Digestive Disease Week meeting in San Diego.
Barrett's esophagus is a condition in which repeated acid reflux causes the cells that normally line the esophagus to be replaced by a different type of cell, similar to those normally found in the intestines. This process is called intestinal metaplasia. By itself Barrett's is not a life-threatening problem, but a small percentage of people with Barrett's will develop esophageal adenocarcinoma, an especially deadly form of cancer.
Radiofrequency ablation, a non-invasive technique that uses thermal energy, or heat, to destroy cells, is very effective at destroying abnormal cells in the esophagus. The new UNC-led study is the first randomized trial to evaluate radiofrequency ablation for treating dysplasia, a more advanced stage of Barrett's esophagus in which the abnormal cells acquire precancerous traits.
The radiofrequency ablation system used in the study uses thermal energy provided by a set of electromagnetic coils on the surface of a balloon, Shaheen said. "The balloon is placed in the area of the esophagus where the offending cells are and the balloon is inflated. Energy is then passed through the electromagnetic coils and, because we know how far apart the coils are spaced and how much energy is being put through them, we get a very reliable depth of burn, such that you can kill the abnormal cells on the inner surface without damaging the whole organ."
In the study to date, 127 people were randomized to receive either radiofrequency ablation or a simulated, "sham" version of the procedure at one of 19 participating medical centers. Among those who received radiofrequency ablation, 85 percent were free of dysplasia 12 months after treatment. Seventy-four percent had no evidence of Barrett's at all in their biopsies. In comparison, none that received sham treatment were free of Barrett's.
"The interim results show there is a substantial difference between treatment with radiofrequency ablation and a placebo or 'sham' treatment," said Dr. Nicholas Shaheen, principal investigator of the study and director of UNC's Center for Esophageal Diseases and Swallowing. "It's a strongly positive finding."
Shaheen, who is also an associate professor of medicine and epidemiology in UNC's Schools of Medicine and Public Health, presented the results Monday, May 19 at the annual Digestive Disease Week meeting in San Diego.
Barrett's esophagus is a condition in which repeated acid reflux causes the cells that normally line the esophagus to be replaced by a different type of cell, similar to those normally found in the intestines. This process is called intestinal metaplasia. By itself Barrett's is not a life-threatening problem, but a small percentage of people with Barrett's will develop esophageal adenocarcinoma, an especially deadly form of cancer.
Radiofrequency ablation, a non-invasive technique that uses thermal energy, or heat, to destroy cells, is very effective at destroying abnormal cells in the esophagus. The new UNC-led study is the first randomized trial to evaluate radiofrequency ablation for treating dysplasia, a more advanced stage of Barrett's esophagus in which the abnormal cells acquire precancerous traits.
The radiofrequency ablation system used in the study uses thermal energy provided by a set of electromagnetic coils on the surface of a balloon, Shaheen said. "The balloon is placed in the area of the esophagus where the offending cells are and the balloon is inflated. Energy is then passed through the electromagnetic coils and, because we know how far apart the coils are spaced and how much energy is being put through them, we get a very reliable depth of burn, such that you can kill the abnormal cells on the inner surface without damaging the whole organ."
In the study to date, 127 people were randomized to receive either radiofrequency ablation or a simulated, "sham" version of the procedure at one of 19 participating medical centers. Among those who received radiofrequency ablation, 85 percent were free of dysplasia 12 months after treatment. Seventy-four percent had no evidence of Barrett's at all in their biopsies. In comparison, none that received sham treatment were free of Barrett's.
MGH Study Confirms Benefit Of Surgery For Gastroesophageal Reflux
Despite the growing availability of prescription and over-the-counter medications for gastroesophageal reflux disease (GERD), surgical treatment remains a viable alternative for patients whose symptoms persist. In the May 2008 Archives of Surgery, surgeons from Massachusetts General Hospital (MGH) report their survey of almost 200 patients who had laparoscopic antireflux surgery at the MGH over a 10-year period. Specifically designed to assess GERD-related symptoms, the survey produced near-normal quality-of-life scores from most respondents, who also indicated considerable satisfaction with their long-term results.
"Our results indicate that, in appropriate selected patients, antireflux surgery is an excellent treatment alternative that provides very good results for patient quality of life," says David Rattner, MD, chief of General and Gastrointestinal Surgery at MGH and senior author of the report.
Many individuals experience gastroesophageal reflux - when acidic stomach contents rise into the lower esophagus, producing the burning sensation called heartburn. When those symptoms become chronic and occur more than twice a week, they are considered GERD. In addition to persistant discomfort, GERD can lead to serious consequences, including bleeding of the esophageal lining and, in the most serious cases, esophageal cancer. Lifestyle changes can reduce some GERD symptoms; and while many patients are helped by over-the-counter or prescription medications, symptoms persist for some individuals. Surgery designed to rebuild and strengthen the muscular valve between the esophagus and the stomach offers an option for these patients and for those who would like to avoid lifetime medication use.
Rattner explains that some recent reports in the medical literature have questioned whether the long-term benefits of surgical repair outweigh the risks present in any sort of surgery. Previous outcomes evaluations, which had inconsistent results, have used a survey designed to assess quality-of-life issues relevant to a number of disorders. This new study uses the Gestroesophageal Reflux Disease - Health-Related Quality-of-Life Scale (GERD-HRQL), which focuses on GERD symptoms. Copies of the GERD-HRQL survey were mailed to about 350 patients who had laparoscopic antireflux surgery at the MGH from 1997 to 2006.
Completed surveys were returned by 191 patients, who were responding an average of five years after surgery. Among patients whose procedure was their first antireflux operation, the average GERD-HRQL score was 5.71, similar to that of the normal population. Scores on the GERD-HRQL can range from 0 to 45, with 0 indicating no GERD-related symptoms. Patients whose procedure had been a reoperation had an average score of 14.25. Among first-procedure respondents, 71 percent indicated they were satisfied with their outcomes, and 88 percent responded that they would have the procedure again.
While 43 percent of respondents reported taking some antireflux medications after their surgery, most of those patients had not had any testing to verify the recurrence of GERD. "Some reports have claimed that resumption of antireflux medications indicates that surgery is a failure, but that isn't necessarily true," Rattner says. "The symptoms of GERD are so non-specific, and patients may resume taking medications on their own. When patients who resume these drugs have been actually tested for the presence of reflux, most of them are shown not to have GERD.
"Only 1.2 percent of survey respondents reported needing repeat surgery, which does not support others' assertions that about half these procedures fail," Rattner adds. "Our results let us say that, when this surgery is performed by an expert surgical team at a high-volume center, the outcome for most patients is excellent." Rattner is a professor of Surgery at Harvard Medical School. The study's co-authors are lead author Denise Gee, MD, MGH Department of Surgery, and Michael Andreoli, Boston University School of Medicine.
Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $500 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, systems biology, transplantation biology and photomedicine.
"Our results indicate that, in appropriate selected patients, antireflux surgery is an excellent treatment alternative that provides very good results for patient quality of life," says David Rattner, MD, chief of General and Gastrointestinal Surgery at MGH and senior author of the report.
Many individuals experience gastroesophageal reflux - when acidic stomach contents rise into the lower esophagus, producing the burning sensation called heartburn. When those symptoms become chronic and occur more than twice a week, they are considered GERD. In addition to persistant discomfort, GERD can lead to serious consequences, including bleeding of the esophageal lining and, in the most serious cases, esophageal cancer. Lifestyle changes can reduce some GERD symptoms; and while many patients are helped by over-the-counter or prescription medications, symptoms persist for some individuals. Surgery designed to rebuild and strengthen the muscular valve between the esophagus and the stomach offers an option for these patients and for those who would like to avoid lifetime medication use.
Rattner explains that some recent reports in the medical literature have questioned whether the long-term benefits of surgical repair outweigh the risks present in any sort of surgery. Previous outcomes evaluations, which had inconsistent results, have used a survey designed to assess quality-of-life issues relevant to a number of disorders. This new study uses the Gestroesophageal Reflux Disease - Health-Related Quality-of-Life Scale (GERD-HRQL), which focuses on GERD symptoms. Copies of the GERD-HRQL survey were mailed to about 350 patients who had laparoscopic antireflux surgery at the MGH from 1997 to 2006.
Completed surveys were returned by 191 patients, who were responding an average of five years after surgery. Among patients whose procedure was their first antireflux operation, the average GERD-HRQL score was 5.71, similar to that of the normal population. Scores on the GERD-HRQL can range from 0 to 45, with 0 indicating no GERD-related symptoms. Patients whose procedure had been a reoperation had an average score of 14.25. Among first-procedure respondents, 71 percent indicated they were satisfied with their outcomes, and 88 percent responded that they would have the procedure again.
While 43 percent of respondents reported taking some antireflux medications after their surgery, most of those patients had not had any testing to verify the recurrence of GERD. "Some reports have claimed that resumption of antireflux medications indicates that surgery is a failure, but that isn't necessarily true," Rattner says. "The symptoms of GERD are so non-specific, and patients may resume taking medications on their own. When patients who resume these drugs have been actually tested for the presence of reflux, most of them are shown not to have GERD.
"Only 1.2 percent of survey respondents reported needing repeat surgery, which does not support others' assertions that about half these procedures fail," Rattner adds. "Our results let us say that, when this surgery is performed by an expert surgical team at a high-volume center, the outcome for most patients is excellent." Rattner is a professor of Surgery at Harvard Medical School. The study's co-authors are lead author Denise Gee, MD, MGH Department of Surgery, and Michael Andreoli, Boston University School of Medicine.
Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $500 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, systems biology, transplantation biology and photomedicine.
TAK-390MR Phase 3 Data Presented At Digestive Disease Week
TAP Pharmaceutical Products Inc. have reported results from three pivotal Phase 3 studies evaluating investigational new drug TAK-390MR, the first proton pump inhibitor (PPI) with an innovative dual delayed release technology, in healing patients with erosive esophagitis (EE) and in maintenance of healed EE. The data were presented at the Digestive Disease Week (DDW) annual meeting in San Diego.
"The innovative dual delayed release technology delivers TAK-390MR in two separate releases, which is a first in the PPI class and makes TAK-390MR a very interesting potential future treatment option," said Dr. David Peura, professor of medicine, University of Virginia Health System, past president of the American Gastroenterological Association.
Data from the two separate EE healing studies demonstrated that patients treated with TAK-390MR 60 mg and 90 mg experienced higher overall healing after eight weeks, versus patients taking lansoprazole 30 mg. In addition, data from a six-month maintenance of healed EE study demonstrated that patients treated with TAK-390MR 30 mg and 60 mg experienced statistically significant overall maintenance and symptom relief over placebo.
Healing of Erosive Esophagitis Studies
TAK-390MR was compared to lansoprazole in two identically designed, double-blind, randomized, controlled trials in patients with confirmed EE. A total of 4,092 patients were enrolled in the two global studies. The primary objective was to evaluate overall healing rates over eight weeks after once-daily administration of TAK-390MR 60 mg or 90 mg or lansoprazole 30 mg. The results for each study were analyzed using life table and crude rate methods.
Results from these trials demonstrated that TAK-390MR 60 mg and 90 mg produced consistently high healing rates for patients with EE. In one study, the life table analysis showed that 93 percent and 95 percent of TAK-390MR patients (60 mg and 90 mg, respectively) experienced healing versus 92 percent of lansoprazole 30 mg patients. The crude rate analysis showed that 87 percent of 60 mg and 89 percent of 90 mg TAK-390MR patients experienced healing versus 85 percent of lansoprazole 30 mg patients.
In a second study, the life table analysis demonstrated that 92 percent of both 60 mg and 90 mg patients experienced healing versus 86 percent of patients on lansoprazole 30 mg. The crude rate evaluation showed that 85 percent and 86 percent of patients treated with TAK-390MR (60 mg and 90 mg, respectively) experienced healing versus 79 percent of patients taking lansoprazole 30 mg. The results for TAK-390MR 90 mg were statistically significantly higher than lansoprazole 30 mg in both studies using crude rate analysis.
The most frequent treatment-related adverse event (AE) for patients in the combined healing studies was diarrhea, which occurred in similar rates across groups (three percent for TAK-390MR 60 mg and 90 mg, versus two percent for lansoprazole 30 mg).
"Findings from both studies demonstrated that patients taking TAK-390MR 60 mg and 90 mg showed numerically higher overall healing than those taking lansoprazole with a similar rate of AEs across groups," said Dr. Prateek Sharma, professor of medicine, gastroenterology section, University of Kansas School of Medicine.
Maintenance of Healed Erosive Esophagitis
TAK-390MR was compared to placebo in a double-blind, randomized, controlled trial in patients with confirmed healing of EE. A total of 445 patients were enrolled in the global, six-month study. The primary objective was to evaluate the overall maintenance rate of healed EE after once-daily administration of TAK-390MR 30 mg, 60 mg, or placebo. A secondary objective was to evaluate the frequency of heartburn over the six-month study.
Results from the trial showed that TAK-390MR 30 mg and 60 mg produced high maintenance rates for patients with healed EE. Maintenance rates were analyzed using both life table and crude rate analyses.
The life table analysis showed that 75 and 83 percent of patients (30 mg and 60 mg respectively) were maintained over six months versus 27 percent of those patients taking placebo. According to the crude rate analysis, 66 percent of patients taking TAK-390MR 30 mg and 60 mg were maintained over six months versus 14 percent on placebo.
TAK-390MR also demonstrated heartburn relief rates during the six month trial. Patients treated with TAK-390MR were heartburn free a median of 99 and 96 percent of nights (30 mg and 60 mg respectively) versus 71 percent of nights for patients treated with placebo. In addition, patients treated with TAK-390MR were heartburn free a median 96 and 91 percent of 24-hour days (30 mg and 60 mg, respectively) versus 29 percent of 24-hour days for patients treated with placebo.
The most frequent treatment related AEs for patients in the six-month maintenance study taking TAK-390MR included flatulence, bloating and distension (2%), diarrhea (2%), dyspeptic signs and symptoms (1%), gastritis (1%), and nausea/vomiting (1%) and were generally similar to placebo.
"The heartburn relief rates are encouraging, particularly when you consider that they reflect symptom relief during the complete 24-hour period," said Dr. David Metz, professor of medicine, University of Pennsylvania School of Medicine. "These maintenance results coupled with the overall healing results are encouraging for the potential of TAK-390MR in treating patients with gastroesophageal reflux disease."
About TAK-390MR
TAK-390MR, an enantiomer of lansoprazole, employs an innovative dual delayed release technology, which is designed to provide two separate releases of drug for extended duration of acid suppression.
These Phase 3 data are part of the new drug application (NDA) filed in December 2007 for TAK-390MR for the treatment of patients with symptomatic GERD, the healing of erosive esophagitis, and the maintenance of healed erosive esophagitis. The NDA was based on global studies conducted in more than 20 countries evaluating approximately 6,000 subjects with erosive and non-erosive GERD.
"The innovative dual delayed release technology delivers TAK-390MR in two separate releases, which is a first in the PPI class and makes TAK-390MR a very interesting potential future treatment option," said Dr. David Peura, professor of medicine, University of Virginia Health System, past president of the American Gastroenterological Association.
Data from the two separate EE healing studies demonstrated that patients treated with TAK-390MR 60 mg and 90 mg experienced higher overall healing after eight weeks, versus patients taking lansoprazole 30 mg. In addition, data from a six-month maintenance of healed EE study demonstrated that patients treated with TAK-390MR 30 mg and 60 mg experienced statistically significant overall maintenance and symptom relief over placebo.
Healing of Erosive Esophagitis Studies
TAK-390MR was compared to lansoprazole in two identically designed, double-blind, randomized, controlled trials in patients with confirmed EE. A total of 4,092 patients were enrolled in the two global studies. The primary objective was to evaluate overall healing rates over eight weeks after once-daily administration of TAK-390MR 60 mg or 90 mg or lansoprazole 30 mg. The results for each study were analyzed using life table and crude rate methods.
Results from these trials demonstrated that TAK-390MR 60 mg and 90 mg produced consistently high healing rates for patients with EE. In one study, the life table analysis showed that 93 percent and 95 percent of TAK-390MR patients (60 mg and 90 mg, respectively) experienced healing versus 92 percent of lansoprazole 30 mg patients. The crude rate analysis showed that 87 percent of 60 mg and 89 percent of 90 mg TAK-390MR patients experienced healing versus 85 percent of lansoprazole 30 mg patients.
In a second study, the life table analysis demonstrated that 92 percent of both 60 mg and 90 mg patients experienced healing versus 86 percent of patients on lansoprazole 30 mg. The crude rate evaluation showed that 85 percent and 86 percent of patients treated with TAK-390MR (60 mg and 90 mg, respectively) experienced healing versus 79 percent of patients taking lansoprazole 30 mg. The results for TAK-390MR 90 mg were statistically significantly higher than lansoprazole 30 mg in both studies using crude rate analysis.
The most frequent treatment-related adverse event (AE) for patients in the combined healing studies was diarrhea, which occurred in similar rates across groups (three percent for TAK-390MR 60 mg and 90 mg, versus two percent for lansoprazole 30 mg).
"Findings from both studies demonstrated that patients taking TAK-390MR 60 mg and 90 mg showed numerically higher overall healing than those taking lansoprazole with a similar rate of AEs across groups," said Dr. Prateek Sharma, professor of medicine, gastroenterology section, University of Kansas School of Medicine.
Maintenance of Healed Erosive Esophagitis
TAK-390MR was compared to placebo in a double-blind, randomized, controlled trial in patients with confirmed healing of EE. A total of 445 patients were enrolled in the global, six-month study. The primary objective was to evaluate the overall maintenance rate of healed EE after once-daily administration of TAK-390MR 30 mg, 60 mg, or placebo. A secondary objective was to evaluate the frequency of heartburn over the six-month study.
Results from the trial showed that TAK-390MR 30 mg and 60 mg produced high maintenance rates for patients with healed EE. Maintenance rates were analyzed using both life table and crude rate analyses.
The life table analysis showed that 75 and 83 percent of patients (30 mg and 60 mg respectively) were maintained over six months versus 27 percent of those patients taking placebo. According to the crude rate analysis, 66 percent of patients taking TAK-390MR 30 mg and 60 mg were maintained over six months versus 14 percent on placebo.
TAK-390MR also demonstrated heartburn relief rates during the six month trial. Patients treated with TAK-390MR were heartburn free a median of 99 and 96 percent of nights (30 mg and 60 mg respectively) versus 71 percent of nights for patients treated with placebo. In addition, patients treated with TAK-390MR were heartburn free a median 96 and 91 percent of 24-hour days (30 mg and 60 mg, respectively) versus 29 percent of 24-hour days for patients treated with placebo.
The most frequent treatment related AEs for patients in the six-month maintenance study taking TAK-390MR included flatulence, bloating and distension (2%), diarrhea (2%), dyspeptic signs and symptoms (1%), gastritis (1%), and nausea/vomiting (1%) and were generally similar to placebo.
"The heartburn relief rates are encouraging, particularly when you consider that they reflect symptom relief during the complete 24-hour period," said Dr. David Metz, professor of medicine, University of Pennsylvania School of Medicine. "These maintenance results coupled with the overall healing results are encouraging for the potential of TAK-390MR in treating patients with gastroesophageal reflux disease."
About TAK-390MR
TAK-390MR, an enantiomer of lansoprazole, employs an innovative dual delayed release technology, which is designed to provide two separate releases of drug for extended duration of acid suppression.
These Phase 3 data are part of the new drug application (NDA) filed in December 2007 for TAK-390MR for the treatment of patients with symptomatic GERD, the healing of erosive esophagitis, and the maintenance of healed erosive esophagitis. The NDA was based on global studies conducted in more than 20 countries evaluating approximately 6,000 subjects with erosive and non-erosive GERD.
The Features Of Chinese Patients With Reflux Esophagitis
Gastroesophageal reflux disease (GERD) is described as the chronic symptoms and/or tissue damage caused by the reflux of abnormal gastric contents to the esophagus. GERD is a common disease, with associated typical symptoms of heartburn and regurgitation.
An article published in the World Journal of Gastroenterology evaluated the clinical and endoscopic features in Chinese patients with reflux esophagitis. This study was conducted by Dr. Wei Li of the Department of Gastroenterology, Beijing Friendship Hospital affiliated with the Capital Medical University.
Of 18,823 patients undergoing endoscopic examination, 1,405 (895 male and 510 female) patients were diagnosed as having reflux esophagitis, with a detection rate of 7.46% (male 9.13% and female 5.65%). The ratio of male to female patients was 1.75:1, with a significant difference. The age of onset was 15¨C89 years, with the mean age of 54.56 ¡À 14.19 years. The mean age of male and female patients was 53.82 ¡À 14.19 and 55.85 ¡À 14.08 years, respectively, with significant difference. The peak age of onset was 40¨C60 years for patients with reflux esophagitis. According to Los Angeles Classification, patients with grade A and B accounted for 90.1% of all patients. There were significant differences in the ages of patients with A and B compared with patients with grade C and D. A total of 277 patients were infected with H pylori , with a significantly decreased infection rate. Of the 1405 patients, 195 patients had associated esophageal hiatal hernia. Combination with esophageal hiatal hernia was not associated with the presence of H pylori infection and gender, but was significantly associated with the severity of esophagitis and age.
The results and conclusions demonstrated the peak age of onset was 40¨C60 years for patients with reflux esophagitis, with more male patients than female ones. The mean age of onset is lower in males than females. The infection rate of H pylori is significantly decreased in patients with esophagitis, but the severity of patients with esophagitis is not associated with H pylori infection. Old age and combination with esophageal hiatal hernia were associated with more severe esophagitis. Right esophageal mucosal damage can occur more often in patients with reflux esophagitis.
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Article adapted by Medical News Today from original press release.
----------------------------
Reference: Li W, Zhang ST, ZL. Clinical and endoscopic features of Chinese reflux esophagitis patients. World J Gastroenterol 2008; 14(12): 1866-1871 http://www.wjgnet.com/1007-9327/14/1866.asp
Correspondence to: Shu-Tian Zhang, Department of Gastroenterology, Beijing Friendship Hospital affiliated with the Capital Medical University; Faculty of Gastroenterology, Capital Medical University; Beijing Digestive Disease Center, Beijing 100050, China.
About World Journal of Gastroenterology
World Journal of Gastroenterology (WJG), a leading international journal in gastroenterology and hepatology, has established a reputation for publishing first class research on esophageal cancer, gastric cancer, liver cancer, viral hepatitis, colorectal cancer, and H pylori infection for providing a forum for both clinicians and scientists. WJG has been indexed and abstracted in Current Contents/Clinical Medicine, Science Citation Index Expanded (also known as SciSearch) and Journal Citation Reports/Science Edition, Index Medicus, MEDLINE and PubMed, Chemical Abstracts, EMBASE/Excerpta Medica, Abstracts Journals, Nature Clinical Practice Gastroenterology and Hepatology, CAB Abstracts and Global Health. ISI JCR 2003-2000 IF: 3.318, 2.532, 1.445 and 0.993. WJG is a weekly journal published by WJG Press. The publication dates are the 7th, 14th, 21st, and 28th day of every month. The WJG is supported by The National Natural Science Foundation of China, No. 30224801 and No. 30424812, and was founded with the name of China National Journal of New Gastroenterology on October 1, 1995, and renamed WJG on January 25, 1998.
About The WJG Press
The WJG Press mainly publishes World Journal of Gastroenterology.
An article published in the World Journal of Gastroenterology evaluated the clinical and endoscopic features in Chinese patients with reflux esophagitis. This study was conducted by Dr. Wei Li of the Department of Gastroenterology, Beijing Friendship Hospital affiliated with the Capital Medical University.
Of 18,823 patients undergoing endoscopic examination, 1,405 (895 male and 510 female) patients were diagnosed as having reflux esophagitis, with a detection rate of 7.46% (male 9.13% and female 5.65%). The ratio of male to female patients was 1.75:1, with a significant difference. The age of onset was 15¨C89 years, with the mean age of 54.56 ¡À 14.19 years. The mean age of male and female patients was 53.82 ¡À 14.19 and 55.85 ¡À 14.08 years, respectively, with significant difference. The peak age of onset was 40¨C60 years for patients with reflux esophagitis. According to Los Angeles Classification, patients with grade A and B accounted for 90.1% of all patients. There were significant differences in the ages of patients with A and B compared with patients with grade C and D. A total of 277 patients were infected with H pylori , with a significantly decreased infection rate. Of the 1405 patients, 195 patients had associated esophageal hiatal hernia. Combination with esophageal hiatal hernia was not associated with the presence of H pylori infection and gender, but was significantly associated with the severity of esophagitis and age.
The results and conclusions demonstrated the peak age of onset was 40¨C60 years for patients with reflux esophagitis, with more male patients than female ones. The mean age of onset is lower in males than females. The infection rate of H pylori is significantly decreased in patients with esophagitis, but the severity of patients with esophagitis is not associated with H pylori infection. Old age and combination with esophageal hiatal hernia were associated with more severe esophagitis. Right esophageal mucosal damage can occur more often in patients with reflux esophagitis.
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
Reference: Li W, Zhang ST, ZL. Clinical and endoscopic features of Chinese reflux esophagitis patients. World J Gastroenterol 2008; 14(12): 1866-1871 http://www.wjgnet.com/1007-9327/14/1866.asp
Correspondence to: Shu-Tian Zhang, Department of Gastroenterology, Beijing Friendship Hospital affiliated with the Capital Medical University; Faculty of Gastroenterology, Capital Medical University; Beijing Digestive Disease Center, Beijing 100050, China.
About World Journal of Gastroenterology
World Journal of Gastroenterology (WJG), a leading international journal in gastroenterology and hepatology, has established a reputation for publishing first class research on esophageal cancer, gastric cancer, liver cancer, viral hepatitis, colorectal cancer, and H pylori infection for providing a forum for both clinicians and scientists. WJG has been indexed and abstracted in Current Contents/Clinical Medicine, Science Citation Index Expanded (also known as SciSearch) and Journal Citation Reports/Science Edition, Index Medicus, MEDLINE and PubMed, Chemical Abstracts, EMBASE/Excerpta Medica, Abstracts Journals, Nature Clinical Practice Gastroenterology and Hepatology, CAB Abstracts and Global Health. ISI JCR 2003-2000 IF: 3.318, 2.532, 1.445 and 0.993. WJG is a weekly journal published by WJG Press. The publication dates are the 7th, 14th, 21st, and 28th day of every month. The WJG is supported by The National Natural Science Foundation of China, No. 30224801 and No. 30424812, and was founded with the name of China National Journal of New Gastroenterology on October 1, 1995, and renamed WJG on January 25, 1998.
About The WJG Press
The WJG Press mainly publishes World Journal of Gastroenterology.
Santarus Announces Development Program For New ZEGERID Prescription Product
Santarus, Inc. (NASDAQ:SNTS), a specialty pharmaceutical company, announced that it is developing a new tablet formulation to add to its ZEGERID® family of branded prescription pharmaceutical products. The new formulation is a swallowable tablet that combines immediate-release omeprazole, a proton pump inhibitor (PPI), with a mix of buffers. Santarus plans to undertake clinical and stability studies with the tablet in preparation for the submission of a New Drug Application to the U.S. Food and Drug Administration. The company's objective is to have the new ZEGERID tablet product commercially available in the U.S. in the second half of 2009.
"Our goal was to design an optimized tablet formulation that has the potential to provide features and benefits that are important to physicians and their patients. We have evaluated the new formulation in a pilot clinical study with positive results," said Gerald T. Proehl, president and chief executive officer of Santarus. "Our progress in developing a ZEGERID tablet formulation reflects our past experience in developing other immediate-release PPI products. We have a successful track record of moving quickly through product and clinical development to regulatory approval for ZEGERID Capsules and Powder for Oral Suspension. We are focused on achieving similar results for this new ZEGERID formulation so we can expand the ZEGERID family of product offerings."
About Currently Marketed ZEGERID Prescription Products
ZEGERID (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension are indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), maintenance of healing and short-term treatment of erosive esophagitis, and short-term treatment of active benign gastric ulcers and active duodenal ulcers. ZEGERID Powder for Oral Suspension 40 mg is also indicated for the reduction of risk of upper gastrointestinal bleeding in critically ill patients.
ZEGERID Capsules and Powder for Oral Suspension contain a combination of omeprazole, a PPI, and sodium bicarbonate, an antacid, which raises the gastric pH and thus protects the omeprazole from acid degradation.
ZEGERID products offer a distinct pharmacological profile - rapidly reaching maximal plasma levels (in approximately 30 minutes) and providing strong acid control. While the correlation of pharmacodynamic data to clinical effect has not been established, the median percentage of time gastric pH was greater than 4 over 24 hours in patients treated with ZEGERID in a pharmacodynamic study ranged from 12.2 hours to 18.6 hours, depending on the strength and dosage form, after repeated once-daily dosing. ZEGERID can be conveniently taken once-a-day on an empty stomach, at least one hour before a meal.
PPIs are widely prescribed for a variety of diseases and disorders of the upper digestive tract. All currently marketed oral PPIs in the U.S., other than ZEGERID, are delayed-release formulations that utilize an enteric coating to protect the PPI from acid degradation, thereby delaying absorption and initial acid suppression. Unlike delayed-release PPIs, ZEGERID Capsules and Powder for Oral Suspension utilize an antacid in lieu of an enteric coating. The antacid neutralizes stomach acid and protects the PPI, omeprazole, from gastric acid degradation and allows for its rapid absorption and suppression of gastric acid.
Important Safety Information
The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. In 178 critically ill patients treated with ZEGERID Powder for Oral Suspension, adverse events generally reflected the serious, underlying medical condition of the patients, but some adverse events occurred with more frequency in patients treated with ZEGERID Powder for Oral Suspension than in those treated with the comparator (acid-controlling) drug. For more information about these and other events, please see Table 13 of the full Prescribing Information. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole.
ZEGERID Capsules contain 304 mg of sodium per dose. ZEGERID Powder for Oral Suspension contains 460 mg of sodium per dose. This should be taken into consideration for patients on a sodium-restricted diet.
Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia. ZEGERID is contraindicated in patients with known hypersensitivity to any component of the formulation.
Since both 20 mg and 40 mg ZEGERID contain the same amount of sodium bicarbonate (1100 mg in capsules, 1680 mg in packets of powder for oral suspension), two 20 mg capsules are not equivalent to, and should not be substituted for, one 40 mg capsule, and two 20 mg packets are not equivalent to, and should not be substituted for, one 40 mg packet.
About Santarus
Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists or primary care physicians. The company's current marketing efforts are primarily focused on ZEGERID Capsules and Powder for Oral Suspension. These products are immediate-release formulations of omeprazole, a widely prescribed PPI. More information about Santarus is available on the company's Web site at http://www.santarus.com.
Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus' business, including, without limitation: difficulties or delays associated with Santarus' product development activities, including product stability, and clinical testing for the new tablet formulation; whether the new tablet formulation achieves the intended safety and efficacy profile and demonstrates features and benefits that are important to physicians and their patients; the timing for commercial availability of the new tablet product and potential for delays associated with the clinical testing and regulatory approval processes; adverse side effects or inadequate therapeutic efficacy of Santarus' products that could result in product recalls, market withdrawals or product liability claims; competition from other pharmaceutical or biotechnology companies and evolving market dynamics, including the impact of currently available generic PPI products and the introduction of additional generic PPI products; the scope and validity of patent protection for the new tablet formulation and Santarus' other ZEGERID products, including the outcome and duration of the pending patent infringement lawsuits against Par Pharmaceutical, Inc., and Santarus' ability to commercialize the new tablet formulation and its other ZEGERID products without infringing the patent rights of others; other difficulties or delays in development, testing, manufacturing and marketing of, and maintaining regulatory approvals for, Santarus' products; and other risks detailed in Santarus' prior press releases as well as in public periodic filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Santarus® and ZEGERID® are registered trademarks of Santarus, Inc.
"Our goal was to design an optimized tablet formulation that has the potential to provide features and benefits that are important to physicians and their patients. We have evaluated the new formulation in a pilot clinical study with positive results," said Gerald T. Proehl, president and chief executive officer of Santarus. "Our progress in developing a ZEGERID tablet formulation reflects our past experience in developing other immediate-release PPI products. We have a successful track record of moving quickly through product and clinical development to regulatory approval for ZEGERID Capsules and Powder for Oral Suspension. We are focused on achieving similar results for this new ZEGERID formulation so we can expand the ZEGERID family of product offerings."
About Currently Marketed ZEGERID Prescription Products
ZEGERID (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension are indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), maintenance of healing and short-term treatment of erosive esophagitis, and short-term treatment of active benign gastric ulcers and active duodenal ulcers. ZEGERID Powder for Oral Suspension 40 mg is also indicated for the reduction of risk of upper gastrointestinal bleeding in critically ill patients.
ZEGERID Capsules and Powder for Oral Suspension contain a combination of omeprazole, a PPI, and sodium bicarbonate, an antacid, which raises the gastric pH and thus protects the omeprazole from acid degradation.
ZEGERID products offer a distinct pharmacological profile - rapidly reaching maximal plasma levels (in approximately 30 minutes) and providing strong acid control. While the correlation of pharmacodynamic data to clinical effect has not been established, the median percentage of time gastric pH was greater than 4 over 24 hours in patients treated with ZEGERID in a pharmacodynamic study ranged from 12.2 hours to 18.6 hours, depending on the strength and dosage form, after repeated once-daily dosing. ZEGERID can be conveniently taken once-a-day on an empty stomach, at least one hour before a meal.
PPIs are widely prescribed for a variety of diseases and disorders of the upper digestive tract. All currently marketed oral PPIs in the U.S., other than ZEGERID, are delayed-release formulations that utilize an enteric coating to protect the PPI from acid degradation, thereby delaying absorption and initial acid suppression. Unlike delayed-release PPIs, ZEGERID Capsules and Powder for Oral Suspension utilize an antacid in lieu of an enteric coating. The antacid neutralizes stomach acid and protects the PPI, omeprazole, from gastric acid degradation and allows for its rapid absorption and suppression of gastric acid.
Important Safety Information
The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. In 178 critically ill patients treated with ZEGERID Powder for Oral Suspension, adverse events generally reflected the serious, underlying medical condition of the patients, but some adverse events occurred with more frequency in patients treated with ZEGERID Powder for Oral Suspension than in those treated with the comparator (acid-controlling) drug. For more information about these and other events, please see Table 13 of the full Prescribing Information. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole.
ZEGERID Capsules contain 304 mg of sodium per dose. ZEGERID Powder for Oral Suspension contains 460 mg of sodium per dose. This should be taken into consideration for patients on a sodium-restricted diet.
Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia. ZEGERID is contraindicated in patients with known hypersensitivity to any component of the formulation.
Since both 20 mg and 40 mg ZEGERID contain the same amount of sodium bicarbonate (1100 mg in capsules, 1680 mg in packets of powder for oral suspension), two 20 mg capsules are not equivalent to, and should not be substituted for, one 40 mg capsule, and two 20 mg packets are not equivalent to, and should not be substituted for, one 40 mg packet.
About Santarus
Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists or primary care physicians. The company's current marketing efforts are primarily focused on ZEGERID Capsules and Powder for Oral Suspension. These products are immediate-release formulations of omeprazole, a widely prescribed PPI. More information about Santarus is available on the company's Web site at http://www.santarus.com.
Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus' business, including, without limitation: difficulties or delays associated with Santarus' product development activities, including product stability, and clinical testing for the new tablet formulation; whether the new tablet formulation achieves the intended safety and efficacy profile and demonstrates features and benefits that are important to physicians and their patients; the timing for commercial availability of the new tablet product and potential for delays associated with the clinical testing and regulatory approval processes; adverse side effects or inadequate therapeutic efficacy of Santarus' products that could result in product recalls, market withdrawals or product liability claims; competition from other pharmaceutical or biotechnology companies and evolving market dynamics, including the impact of currently available generic PPI products and the introduction of additional generic PPI products; the scope and validity of patent protection for the new tablet formulation and Santarus' other ZEGERID products, including the outcome and duration of the pending patent infringement lawsuits against Par Pharmaceutical, Inc., and Santarus' ability to commercialize the new tablet formulation and its other ZEGERID products without infringing the patent rights of others; other difficulties or delays in development, testing, manufacturing and marketing of, and maintaining regulatory approvals for, Santarus' products; and other risks detailed in Santarus' prior press releases as well as in public periodic filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Santarus® and ZEGERID® are registered trademarks of Santarus, Inc.
Cutting Edge Acid Reflux Test Patient-Friendly And Accurate, Improving Diagnosis And Treatment - Restech Dx-pH Measurement System Adopted By CCENT
The Restech Corporation announced that the Central California Ear, Nose & Throat Medical Group (CCENT) of Fresno, California, has adopted the Restech Dx-pH Measurement System to detect acid reflux in the throat. An alarming increase in the incidence of gastroesophageal reflux disease (GERD) and laryngopharyngeal reflux disease (LPRD) in Americans has led to the need for accurate diagnosis of acid reflux as provided by this system.
"The Restech Dx-pH Measurement System allows us to easily measure stomach acid levels in the throats of patients and to correlate these levels with patient symptoms," said Dr. Bret Sherman, M.D., Ph.D., an Otolaryngologist at CCENT specializing in acid reflux disorders. "It is the easiest, most comfortable, and most reliable procedure available to measure acid levels in the upper airway of patients. The system vastly improves treatment as we are now able to determine exactly when and how much stomach acid reaches the throat. This leads to significantly better healthcare for our patients with throat and voice problems."
Patients are first seen by a CCENT ear, nose and throat specialist or speech pathologist because of throat irritation or voice problems. If an initial examination indicates voice pathology, the Restech Dx-pH Measurement System can be used to determine whether stomach acid is refluxing into the larynx. If acid reflux is indeed present, the correct drug treatment plan can be prescribed. If no acid is detected in the upper airway, a different cause for symptoms can be investigated. Prior to the Restech Dx-pH Measurement System, patients were routinely prescribed drug treatments because there were no accurate tests to determine whether stomach acid was refluxing into the upper airway and throat.
Restech Dx-pH Measurement System
The Restech Dx-pH Measurement System is a revolutionary system that comfortably measures pH in the airway. It had been difficult to detect such reflux in the upper airway because, until now, available pH catheters only measured liquid reflux in the esophagus and not the aerosolized form of stomach acid found in the larynx and throat.
Gastric reflux in the upper airway, or laryngopharyngeal reflux, commonly takes a gaseous form that cannot easily be measured using conventional technology. The miniaturized pH sensor at the tip of the Dx-pH Probe is the only sensor able to measure pH in this area. By measuring such pH levels, the Dx-System enables physicians to determine the existence of laryngopharyngeal reflux and to correlate the reflux to various patient symptoms.
The first device capable of measuring pH in the throat in real-time, the Restech Dx-pH Measurement System sends measurements wirelessly to a miniature recording device which is easily carried by the patients during the test period, providing a simple and effective way to monitor reflux. Upon completion of the testing period (usually 24 hours), the patient returns to the physician's office where the device is plugged into a computer and measurements are downloaded for evaluation.
The Dx-pH Probe is 1.5mm in diameter and rests at a comfortable position in the back of the throat behind the soft palate and does not disrupt normal activity or eating. Prior to the development of the Restech Dx-pH Measurement System, physicians testing for reflux had to send their patients home with a probe extending into the patient's esophagus. The positioning and size of those probes were very uncomfortable and interfered with normal activity such as eating and sleeping. The Restech Dx-pH Measurement System allows patients to carry on normal, everyday behavior including eating, exercise, work, bathing, and sleeping with minimal disruption to their lives.
About Central California Ear, Nose & Throat Medical Group
Central California Ear, Nose & Throat Medical Group (CCENT) is a prominent otolaryngology practice that was established in 1966. The practice and facilities are located between Los Angeles and San Francisco in the San Joaquin Valley, with offices in Fresno and Visalia. CCENT currently has eight ENT physicians with general otolaryngology and sub-specialty expertise. The facility includes comprehensive audiologic and vestibular testing, speech pathology, videostroboscopy, and an ambulatory surgical pavilion. CCENT enjoys affiliation with the University of California San Francisco. The practice thrives in a community with five major hospitals and complements patient care with excellent support services. Their on-site ambulatory surgery center is state-of-the-art and outfitted with advanced resources like image guidance technology.
About Restech
Restech is a leader in engineering world class medical technologies that provide comfortable, reliable solutions to assist physicians in the diagnosis of reflux related health problems quickly and reliably.
The innovative engineering team at Restech is led by professionals with over two decades experience each in medical device development. Together, the Restech staff hold over 30 patents in the areas of sensor technology, data recording & monitoring systems, and other medical devices.
"The Restech Dx-pH Measurement System allows us to easily measure stomach acid levels in the throats of patients and to correlate these levels with patient symptoms," said Dr. Bret Sherman, M.D., Ph.D., an Otolaryngologist at CCENT specializing in acid reflux disorders. "It is the easiest, most comfortable, and most reliable procedure available to measure acid levels in the upper airway of patients. The system vastly improves treatment as we are now able to determine exactly when and how much stomach acid reaches the throat. This leads to significantly better healthcare for our patients with throat and voice problems."
Patients are first seen by a CCENT ear, nose and throat specialist or speech pathologist because of throat irritation or voice problems. If an initial examination indicates voice pathology, the Restech Dx-pH Measurement System can be used to determine whether stomach acid is refluxing into the larynx. If acid reflux is indeed present, the correct drug treatment plan can be prescribed. If no acid is detected in the upper airway, a different cause for symptoms can be investigated. Prior to the Restech Dx-pH Measurement System, patients were routinely prescribed drug treatments because there were no accurate tests to determine whether stomach acid was refluxing into the upper airway and throat.
Restech Dx-pH Measurement System
The Restech Dx-pH Measurement System is a revolutionary system that comfortably measures pH in the airway. It had been difficult to detect such reflux in the upper airway because, until now, available pH catheters only measured liquid reflux in the esophagus and not the aerosolized form of stomach acid found in the larynx and throat.
Gastric reflux in the upper airway, or laryngopharyngeal reflux, commonly takes a gaseous form that cannot easily be measured using conventional technology. The miniaturized pH sensor at the tip of the Dx-pH Probe is the only sensor able to measure pH in this area. By measuring such pH levels, the Dx-System enables physicians to determine the existence of laryngopharyngeal reflux and to correlate the reflux to various patient symptoms.
The first device capable of measuring pH in the throat in real-time, the Restech Dx-pH Measurement System sends measurements wirelessly to a miniature recording device which is easily carried by the patients during the test period, providing a simple and effective way to monitor reflux. Upon completion of the testing period (usually 24 hours), the patient returns to the physician's office where the device is plugged into a computer and measurements are downloaded for evaluation.
The Dx-pH Probe is 1.5mm in diameter and rests at a comfortable position in the back of the throat behind the soft palate and does not disrupt normal activity or eating. Prior to the development of the Restech Dx-pH Measurement System, physicians testing for reflux had to send their patients home with a probe extending into the patient's esophagus. The positioning and size of those probes were very uncomfortable and interfered with normal activity such as eating and sleeping. The Restech Dx-pH Measurement System allows patients to carry on normal, everyday behavior including eating, exercise, work, bathing, and sleeping with minimal disruption to their lives.
About Central California Ear, Nose & Throat Medical Group
Central California Ear, Nose & Throat Medical Group (CCENT) is a prominent otolaryngology practice that was established in 1966. The practice and facilities are located between Los Angeles and San Francisco in the San Joaquin Valley, with offices in Fresno and Visalia. CCENT currently has eight ENT physicians with general otolaryngology and sub-specialty expertise. The facility includes comprehensive audiologic and vestibular testing, speech pathology, videostroboscopy, and an ambulatory surgical pavilion. CCENT enjoys affiliation with the University of California San Francisco. The practice thrives in a community with five major hospitals and complements patient care with excellent support services. Their on-site ambulatory surgery center is state-of-the-art and outfitted with advanced resources like image guidance technology.
About Restech
Restech is a leader in engineering world class medical technologies that provide comfortable, reliable solutions to assist physicians in the diagnosis of reflux related health problems quickly and reliably.
The innovative engineering team at Restech is led by professionals with over two decades experience each in medical device development. Together, the Restech staff hold over 30 patents in the areas of sensor technology, data recording & monitoring systems, and other medical devices.
Revolutionary Non-Invasive Surgery For Acid Reflux Disease Now Available At Mercy Medical Center
Mercy Medical Center has become the first hospital in the Northeast to offer a new, revolutionary non-invasive procedure that surgically treats chronic heartburn resulting from GastroEsophageal Reflux Disease (GERD).
A team headed by Shawn Garber, MD, Chief of Bariatric Surgery at Mercy, with colleague Spencer Holover, MD, is one of only a handful in the entire country to offer the technique, known as EsophyXTM Transoral Incisionless Fundoplication (TIF), a form of Natural Orifice Surgery (NOS) in which a device for performing reconstructive gastrointestinal procedures is introduced into the body through the mouth, rather than through an abdominal incision.
"EsophyX transoral incisionless surgery provides an important new option in the treatment of intractable acid reflux disease," explained Dr. Garber, who heads the New York Bariatric Group. "Unlike conventional laparoscopic procedures for surgical remediation of GERD, the transoral technique that introduces the surgical instruments through the mouth, reduces the risk of infection from incisions, preserves future treatment options, nearly eliminates pain for the patient, and requires less recovery time."
In the first operation of its kind in the Northeast, the team at Mercy Medical Center recently performed the EsophyX procedure several weeks ago on a 65-year-old New Jersey woman who had been experiencing severe heartburn from acid reflux disease for many years, and had obtained no relief from dietary and lifestyle changes, or any over-the-counter or prescription medication treatments. As a result of the surgery, her GERD has dissipated and she no longer requires medication.
It's been estimated that as many as one in four people in Western nations suffer from heartburn at least once per month; that 12 percent experience the burning and pain at least once per week; and that more than 5 percent suffer on a daily basis. Those experiencing heartburn twice a week or more over a six month period are likely to have GastroEsophageal Reflux Disease, which results from excess stomach acid backing-up into the esophagus (the tube connecting the mouth to the stomach) due the failure of a muscular valve at the bottom of the esophagus to close properly.
Dietary and lifestyle changes, as well as over-the-counter and prescription medications treat GERD by reducing the amount of acid produced in the stomach. Medications can alleviate symptoms but generally do not stop the progression of the condition, and often must be taken for the rest of a patient's life. For severe cases, conventional laparoscopic surgery can repair the gastroesophageal valve with instruments introduced into the abdomen through small incisions. The EsophyX transoral procedure, developed by EndoGastric SolutionsTM of Redmond, Washington, eliminates the need for incisions, and the associated pain and risk of infection, by introducing the surgical instruments through the patient's mouth.
A similar bariatric procedure, called StomaphyXTM, for reducing the size of a patient's stomach for individuals who gain weight a few years after gastric bypass surgery, has been available at Mercy Medical Center since last July.
A team headed by Shawn Garber, MD, Chief of Bariatric Surgery at Mercy, with colleague Spencer Holover, MD, is one of only a handful in the entire country to offer the technique, known as EsophyXTM Transoral Incisionless Fundoplication (TIF), a form of Natural Orifice Surgery (NOS) in which a device for performing reconstructive gastrointestinal procedures is introduced into the body through the mouth, rather than through an abdominal incision.
"EsophyX transoral incisionless surgery provides an important new option in the treatment of intractable acid reflux disease," explained Dr. Garber, who heads the New York Bariatric Group. "Unlike conventional laparoscopic procedures for surgical remediation of GERD, the transoral technique that introduces the surgical instruments through the mouth, reduces the risk of infection from incisions, preserves future treatment options, nearly eliminates pain for the patient, and requires less recovery time."
In the first operation of its kind in the Northeast, the team at Mercy Medical Center recently performed the EsophyX procedure several weeks ago on a 65-year-old New Jersey woman who had been experiencing severe heartburn from acid reflux disease for many years, and had obtained no relief from dietary and lifestyle changes, or any over-the-counter or prescription medication treatments. As a result of the surgery, her GERD has dissipated and she no longer requires medication.
It's been estimated that as many as one in four people in Western nations suffer from heartburn at least once per month; that 12 percent experience the burning and pain at least once per week; and that more than 5 percent suffer on a daily basis. Those experiencing heartburn twice a week or more over a six month period are likely to have GastroEsophageal Reflux Disease, which results from excess stomach acid backing-up into the esophagus (the tube connecting the mouth to the stomach) due the failure of a muscular valve at the bottom of the esophagus to close properly.
Dietary and lifestyle changes, as well as over-the-counter and prescription medications treat GERD by reducing the amount of acid produced in the stomach. Medications can alleviate symptoms but generally do not stop the progression of the condition, and often must be taken for the rest of a patient's life. For severe cases, conventional laparoscopic surgery can repair the gastroesophageal valve with instruments introduced into the abdomen through small incisions. The EsophyX transoral procedure, developed by EndoGastric SolutionsTM of Redmond, Washington, eliminates the need for incisions, and the associated pain and risk of infection, by introducing the surgical instruments through the patient's mouth.
A similar bariatric procedure, called StomaphyXTM, for reducing the size of a patient's stomach for individuals who gain weight a few years after gastric bypass surgery, has been available at Mercy Medical Center since last July.
New Test Could Aid Children Suffering From Reflux Disease
A nuclear medicine imaging test was used to confirm that children with respiratory problems may be more likely to develop gastroesophageal reflux disease, according to researchers at SNM's 55th Annual Meeting. The nuclear imaging technique, known as scintigraphy, was also shown to be more effective in detecting the disease in these children than traditional barium X-ray technology. The results indicate that scintigraphy could become an important diagnostic tool for detecting reflux disease, a serious condition that can lead to chronic chest pain, vomiting, weight loss and lung impairment in children who suffer from it.
"Unfortunately, reflux disease is a common problem in children, especially for those with respiratory problems," said Wajiha Nasir, a researcher at the Nuclear Medicine Oncology and Radiotherapy Institute (NORI), Islamabad, Pakistan. "If left untreated, the disease can seriously impede children's health, growth and development, not to mention their quality of life. Our results show that scintigraphy is highly effective at safely diagnosing the condition."
Reflux disease occurs when the esophagus becomes irritated or inflamed by stomach contents. The stomach produces hydrochloric acid after a meal to aid in the digestion of food. Normally, a ring of muscle at the bottom of the esophagus, called the lower esophageal sphincter, prevents the acid from going back up the esophagus. With reflux disease, however, the sphincter relaxes between swallows, allowing stomach contents and corrosive acid to well up and damage the lining of the esophagus.
The chronic condition affects up to a third of adults, and many infants and children also suffer from it. Some of these children outgrow the condition as their digestive systems mature, but many do not. Researchers have long suspected that children who have respiratory problems such as asthma might also be more susceptible to reflux disease.
Scintigraphy is a diagnostic test in which a two-dimensional picture is obtained through detection of a radiation emitted by a radioactive source given to the body. In this study, 55 children aged six months to 12 years who had asthma or lower respiratory tract infections were orally administered a commonly used radioactive imaging agent that was then detected through scintigraphy technology.
The test detected reflux disease in 66.6 percent of the children, revealing a strong association between reflux disease and respiratory disease. In addition, scintigraphy proved more effective at detecting the disease than traditional barium x-rays. Children in the study who exhibited reflux disease were given medication to treat reflux. At a three-month follow-up visit, most of the children's symptoms had improved after receiving the medication.
"Scintigraphy is one of the simplest radionuclide tests to administer, with a very low radiation burden," said Nasir. If performed routinely for children suffering from bronchial asthma and recurrent respiratory tract infections, this test could get children the treatment they deserve."
"Unfortunately, reflux disease is a common problem in children, especially for those with respiratory problems," said Wajiha Nasir, a researcher at the Nuclear Medicine Oncology and Radiotherapy Institute (NORI), Islamabad, Pakistan. "If left untreated, the disease can seriously impede children's health, growth and development, not to mention their quality of life. Our results show that scintigraphy is highly effective at safely diagnosing the condition."
Reflux disease occurs when the esophagus becomes irritated or inflamed by stomach contents. The stomach produces hydrochloric acid after a meal to aid in the digestion of food. Normally, a ring of muscle at the bottom of the esophagus, called the lower esophageal sphincter, prevents the acid from going back up the esophagus. With reflux disease, however, the sphincter relaxes between swallows, allowing stomach contents and corrosive acid to well up and damage the lining of the esophagus.
The chronic condition affects up to a third of adults, and many infants and children also suffer from it. Some of these children outgrow the condition as their digestive systems mature, but many do not. Researchers have long suspected that children who have respiratory problems such as asthma might also be more susceptible to reflux disease.
Scintigraphy is a diagnostic test in which a two-dimensional picture is obtained through detection of a radiation emitted by a radioactive source given to the body. In this study, 55 children aged six months to 12 years who had asthma or lower respiratory tract infections were orally administered a commonly used radioactive imaging agent that was then detected through scintigraphy technology.
The test detected reflux disease in 66.6 percent of the children, revealing a strong association between reflux disease and respiratory disease. In addition, scintigraphy proved more effective at detecting the disease than traditional barium x-rays. Children in the study who exhibited reflux disease were given medication to treat reflux. At a three-month follow-up visit, most of the children's symptoms had improved after receiving the medication.
"Scintigraphy is one of the simplest radionuclide tests to administer, with a very low radiation burden," said Nasir. If performed routinely for children suffering from bronchial asthma and recurrent respiratory tract infections, this test could get children the treatment they deserve."
FDA Approves ACIPHEX(R) (rabeprazole Sodium) 20 Mg For Short-Term Treatment Of GERD In Adolescents
Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., announced that the Food and Drug Administration (FDA) has approved ACIPHEX (rabeprazole sodium) 20 mg for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in adolescents ages 12 and above.
Included in the submission was a 12-week, multi-center, open-label, randomized, parallel-group study of 111 adolescent GERD patients. In this study, ACIPHEX was well tolerated in adolescent subjects, with a safety profile similar to that of adults. The adverse events reported without regard to relationship to ACIPHEX that occurred in greater than or equal to 2 percent of 111 patients were headache (9.9 percent), diarrhea (4.5 percent), nausea (4.5 percent), vomiting (3.6 percent) and abdominal pain (3.6 percent). Efficacy results demonstrated that once-daily treatment with ACIPHEX 20 mg for eight weeks reduced the severity and frequency of GERD symptoms compared to symptoms prior to treatment.
ACIPHEX was discovered and developed by Eisai and is copromoted in the United States with PriCara(R), a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
About ACIPHEX(R) (rabeprazole sodium)
ACIPHEX(R) is a prescription medication. ACIPHEX 20 mg tablet once daily is approved for use in adults:
-- for the short-term (4 to 8 weeks) treatment in the healing and symptom relief of damaging (erosive) Gastroesophageal Reflux Disease (GERD).
-- to maintain healing of damage (erosions) and relief of heartburn symptoms with GERD. ACIPHEX has not been studied for treatment lasting longer than 12 months (1 year).
-- for the treatment of day-time and night-time heartburn and other symptoms that happen with GERD.
ACIPHEX 20 mg once daily is now also indicated for adolescents ages 12 and above for the short-term treatment (up to 8 weeks) for heartburn and other GERD symptoms. The safety and effectiveness of ACIPHEX has not been established for children under the age of 12.
Important Safety Information
ACIPHEX has a well-established safety profile. The most common side effect possibly related to ACIPHEX is headache. Symptom relief does not rule out other serious stomach conditions. Patients on warfarin (such as Coumadin(R)) may need to be monitored more closely by their doctor. To learn more, talk to your doctor and see the full product information at http://www.aciphex.com.
About Eisai Corporation of North America
Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care.
Eisai Corporation of North America supports the activities of its operating companies in North America. These operating companies include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; MGI PHARMA, INC., an R&D and commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery.
For more information about Eisai, please visit http://www.eisai.com.
ACIPHEX is a registered trademark of Eisai Co., Ltd.
Coumadin is a registered trademark of Bristol-Myers Squibb Pharma Company.
Included in the submission was a 12-week, multi-center, open-label, randomized, parallel-group study of 111 adolescent GERD patients. In this study, ACIPHEX was well tolerated in adolescent subjects, with a safety profile similar to that of adults. The adverse events reported without regard to relationship to ACIPHEX that occurred in greater than or equal to 2 percent of 111 patients were headache (9.9 percent), diarrhea (4.5 percent), nausea (4.5 percent), vomiting (3.6 percent) and abdominal pain (3.6 percent). Efficacy results demonstrated that once-daily treatment with ACIPHEX 20 mg for eight weeks reduced the severity and frequency of GERD symptoms compared to symptoms prior to treatment.
ACIPHEX was discovered and developed by Eisai and is copromoted in the United States with PriCara(R), a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
About ACIPHEX(R) (rabeprazole sodium)
ACIPHEX(R) is a prescription medication. ACIPHEX 20 mg tablet once daily is approved for use in adults:
-- for the short-term (4 to 8 weeks) treatment in the healing and symptom relief of damaging (erosive) Gastroesophageal Reflux Disease (GERD).
-- to maintain healing of damage (erosions) and relief of heartburn symptoms with GERD. ACIPHEX has not been studied for treatment lasting longer than 12 months (1 year).
-- for the treatment of day-time and night-time heartburn and other symptoms that happen with GERD.
ACIPHEX 20 mg once daily is now also indicated for adolescents ages 12 and above for the short-term treatment (up to 8 weeks) for heartburn and other GERD symptoms. The safety and effectiveness of ACIPHEX has not been established for children under the age of 12.
Important Safety Information
ACIPHEX has a well-established safety profile. The most common side effect possibly related to ACIPHEX is headache. Symptom relief does not rule out other serious stomach conditions. Patients on warfarin (such as Coumadin(R)) may need to be monitored more closely by their doctor. To learn more, talk to your doctor and see the full product information at http://www.aciphex.com.
About Eisai Corporation of North America
Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care.
Eisai Corporation of North America supports the activities of its operating companies in North America. These operating companies include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; MGI PHARMA, INC., an R&D and commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery.
For more information about Eisai, please visit http://www.eisai.com.
ACIPHEX is a registered trademark of Eisai Co., Ltd.
Coumadin is a registered trademark of Bristol-Myers Squibb Pharma Company.
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