Healthcare Industry News: GERD
News Release - July 25, 2006
NEXIUM(R) Maintains Healing of Erosive Esophagitis Better Than Lansoprazole, New Study ShowsData, highlighted in Clinical Gastroenterology and Hepatology, provide insights into comparative efficacy of PPI therapies
WILMINGTON, Del., July 25 (HSMN NewsFeed) -- A new study involving more than 1,000 patients with healed erosive esophagitis (EE), reports that NEXIUM® (esomeprazole magnesium) is more effective than lansoprazole (Prevacid®) in preventing a recurrence and is equally effective in reducing its associated symptoms. The results of the study, published in this month's issue of Clinical Gastroenterology and Hepatology, corroborate results from previous head-to-head trials demonstrating the efficacy of NEXIUM as compared to other proton pump inhibitors (PPIs) in maintaining erosive esophageal healing.(1)
An estimated one in three people with acid reflux disease develop erosive esophagitis, in which stomach acid begins to wear away, or erode, the inner lining of the esophagus. Acid reflux disease is a condition in which the valve between the esophagus and stomach doesn't close properly, allowing acid to leak back into the esophagus. Symptoms of acid reflux disease and erosive esophagitis are similar and may include persistent heartburn (a burning sensation), acid regurgitation, a sour or bitter taste in the mouth, and difficulty swallowing.
The double-blind, randomized, double-dummy, parallel-group trial demonstrated that more patients who took NEXIUM 20 mg once daily maintained healing of erosive esophagitis over six months compared with patients treated with lansoprazole 15 mg once daily. (Their remission rate - i.e., no recurrence of erosive esophagitis and no withdrawals from the study due to an increase in acid reflux symptoms - was significantly higher [84.8%] than that of lansoprazole-treated patients [75.9%]; p=0.0007.)
"The challenge in treating erosive esophagitis is that many patients who are successfully treated with an acid-suppressing medication, such as a PPI, will commonly relapse within a year if that medication is discontinued. Reflux symptoms are chronic in many patients, particularly those with erosive esophagitis," said Kenneth DeVault, MD, director of gastrointestinal research, Mayo Clinic College of Medicine, Jacksonville, Florida, and the lead study investigator.
"The study showed that esomeprazole (NEXIUM) was more effective than lansoprazole in meeting one of the important yardsticks for clinical success - maintaining healing of erosive esophagitis," added Dr. DeVault. "Esomeprazole therapy was able to control both mucosal damage and reflux symptoms."
The trial was a randomized, double-blind, double-dummy, parallel-group study to compare the endoscopic and symptomatic remission rates of NEXIUM with those of lansoprazole in patients with healed grade A-D erosive esophagitis. (Grades were based on the Los Angeles Classification System, which categorizes the severity of esophageal inflammation. Grades A and B indicate mild erosive esophagitis, and C and D represent severe disease.)
A total of 1,026 patients were randomized to once-daily therapy with either NEXIUM 20 mg (n=512) or lansoprazole 15 mg (n=514) for up to six months. Patients with grades C and D erosive esophagitis at baseline had been previously treated and healed (no endoscopic evidence of the disease) with either NEXIUM 40 mg or lansoprazole 30 mg once daily, while those with grades A and B erosive esophagitis had been successfully treated with NEXIUM 40 mg. An upper endoscopy (an examination of the esophagus, stomach and upper part of the small intestine) was performed at three and six months to determine the relative remission rates of both treatment groups. Patients in both groups had no heartburn or acid regurgitation symptoms during the week prior to each endoscopy. Both NEXIUM and lansoprazole were well-tolerated by patients.
AstraZeneca funded the study, which was conducted by Mayo Clinic College of Medicine, Rockford Gastroenterology Associates and Eastern Virginia Medical School.
About NEXIUM® (esomeprazole magnesium) Delayed-release Capsules
NEXIUM is approved for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease as well as healing erosive esophagitis. Most erosions heal in four to eight weeks. Individual results may vary, and only a doctor can determine if erosions to the esophagus have occurred. Symptom relief does not rule out the existence of other serious stomach conditions. NEXIUM also is indicated for reducing the risk of gastric (stomach) ulcers developing among at-risk patients on continuous non-steroidal anti-inflammatory drug (NSAID) therapy. Patients are considered to be at risk if they are 60 and over, or if they have a history of previous stomach ulcer.
The most frequently reported adverse events with NEXIUM include headache, diarrhea, and abdominal pain. For full prescribing information for NEXIUM please visit http://www.nexium-us.com.
AstraZeneca (NYSE: AZN ) 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 $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology, and infection products. In the United States, AstraZeneca is a $10.77 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com.
(1) Labenz J, et al. A randomized comparative study of esomeprazole 40 mg vs. pantoprazole 40 mg for healing erosive esophagitis: the EXPO study. Aliment Pharmacol Ther 2005;21:739-746.
Kahrilas PJ, et al, for the Esomeprazole Study Investigators. Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux oesophagitis patients: a randomized, controlled trial. Aliment Pharmacol Ther 2000;14:1249-1258.
Richter JE, et al., for the Esomeprazole Study Investigators. Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis: a randomized controlled trial. Am J Gastroenterol 2001;96:656-665.
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