To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Triple Therapy Including Prilosec Approved For H. Pylori Treatment URL: http://www.pslgroup.com/dg/8A2C2.htm Doctor's Guide June 30, 1998
WAYNE, PA -- June 30, 1998 – The United States Food and Drug Administration has approved Astra Merck Inc.'s 10-day, triple therapy regimen combining its antisecretory medication Prilosec(R) (omeprazole) for use with the antibiotics Biaxin(R) (clarithromycin) and amoxicillin to treat Helicobacter pylori infection in patients with duodenal ulcer disease. The triple combination regimen represents the only 10-day treatment option in the eradication of H. pylori approved by the FDA. This marks a second H. pylori indication for Prilosec since FDA approval of a 14-day dual treatment regimen of Prilosec and Biaxin. Eradication of H. pylori, the bacterium now believed to cause approximately 90 percent of duodenal ulcers, has been shown to reduce the risk of ulcer recurrence. The new triple combination therapy may help many patients with chronic duodenal ulcer disease be free of H. pylori infection after the 10-day course of therapy. Biaxin is marketed by Abbott Laboratories. In three separate clinical studies, H. pylori was eradicated in 90%, 78% and 77% of the patients on triple therapy. The recommended dosage for eradicating H. pylori infection associated with active and inactive (up to one-year history of duodenal ulcer) duodenal ulcers is 20 mg of Prilosec, 500 mg of Biaxin and 1,000 mg of amoxicillin each given twice a day for 10 days. The combination regimen is generally well-tolerated. The most common side effects include diarrhea, taste perversion, and headache. In addition to being the only approved 10-day course of therapy approved by the FDA, the triple drug combination is also notable for its indicated use in the treatment of both active duodenal ulcer and up to a one-year history of duodenal ulcer. For patients with active duodenal ulcers, an additional course of therapy with Prilosec 20 mg once daily for 18 days is recommended following initial treatment. "Patients who have had a duodenal ulcer diagnosed within the last year should discuss treatment with their physicians even if they haven't had symptoms recently since duodenal ulcers usually recur if the H. pylori bacterium is not eradicated," said Dr. Loren Laine, chief of the gastroenterology section at Los Angeles County USC Medical Center. "The effectiveness of the combined medications and the short, relatively simple regimen represent an attractive way to eradicate H. pylori and reduce the risk for recurrence of duodenal ulcers." Peptic ulcers, which include duodenal ulcers, ulcers in the first part of the small intestine called the duodenum and ulcers found in the stomach affect approximately five million Americans each year. It is estimated that 10 percent of people will develop an ulcer during their lifetimes. Duodenal ulcers were once thought to be caused by lifestyle factors such as stress and diet. In recent years, research has demonstrated that most duodenal ulcers are caused by H. pylori infection. More information on: Prilosec, Biaxin, Astra, Merck and Abbott Laboratories --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.