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| |  Prevacid Clearance For Duodenal Ulcers DEERFIELD, Ill., June 20, 1997 – The U.S. Food and Drug Administration (FDA) has granted marketing clearance for Prevacid (lansoprazole, TAP Holdings Inc.) in combination with Biaxin (clarithromycin, Abbott Laboratories) and amoxicillin as triple therapy for the eradication of Helicobacter pylori (H. pylori) infection in patients with active or recurrent duodenal (small intestinal) ulcers. Eradication of H. pylori -- a bacterium that is believed to be responsible for more than 90 percent of duodenal ulcers -- has been shown to enhance healing of duodenal ulcers and reduce the risk of recurrence. "Eradication of H. pylori has become the new goal for treating ulcers," said David A. Peura, M.D., Professor of Medicine and Associate Chief of the Division of Gastroenterology and Hepatology at the University of Virginia at Charlottesville. "Prevacid triple therapy, which has a high eradication rate, will help doctors achieve this goal, and think in terms of preventing the recurrence of ulcers instead of simply treating them over and over again." In two U.S. clinical studies, when Prevacid triple therapy was administered for two weeks, H. pylori was eradicated in 86 to 92 percent of patients studied. In an intent-to-treat analysis of all patients enrolled in the clinical trials, eradication rates remained high (83 percent to 86 percent). Recently, an international panel of experts convened by the American Digestive Health Foundations emphasized the importance of eradicating H. pylori in patients with ulcers, and recommended that patients diagnosed with complicated ulcers be tested for H. pylori. Peptic ulcers, including duodenal and gastric (stomach) ulcers, affect approximately 25 million Americans. Prevacid triple therapy consists of the proton pump inhibitor Prevacid and two broad-spectrum antibiotics, clarithromycin and amoxicillin. The medications are taken twice a day for two weeks. The only other proton pump inhibitor-plus-antibiotic treatment cleared by the FDA for the eradication of H. pylori requires two weeks of combined proton pump inhibitor-plus-antibiotic treatment, followed by an additional two weeks of treatment with a proton pump inhibitor. According to a National Institutes of Health Consensus Development Conference on H. pylori in peptic ulcer disease, shorter treatment regimens may enhance compliance with therapy, improving the chance of successful outcomes and reducing the risk of duodenal ulcer recurrence. "Eradicating the underlying H. pylori infection is a primary goal of anti-ulcer therapy, but many patients have difficulty following the often complex, lengthy treatment regimens," said Dr. Peura. "The shorter, twice-a-day dosing regimen of Prevacid triple therapy may be of value in helping patients comply with their treatment regimen." Clinical Findings With Prevacid Triple Therapy Results from two U.S. randomized, double-blind clinical studies showed that 30 mg Prevacid plus 500 mg clarithromycin and 1 g amoxicillin given twice daily for 14 days eradicated H. pylori in 92 and 86 percent of patients. Previous studies of Prevacid alone have demonstrated that the drug is well tolerated. Side effects of Prevacid triple therapy were similar to those commonly seen with Prevacid, amoxicillin, and clarithromycin treatment alone. The most frequently reported adverse events for this triple therapy regimen were diarrhea (7 percent), headache (6 percent) and taste disturbance (5 percent). Clarithromycin is contraindicated in patients taking terfenadine who have preexisting cardiac abnormalities or electrolyte imbalances. Additionally, clarithromycin may elevate serum digoxin levels in patients who are taking digoxin concomitantly. Clarithromycin should not be used in pregnant women. Amoxicillin is contraindicated in patients who are allergic to penicillin. About Prevacid Prevacid is a proton pump inhibitor (PPI), which blocks the production of stomach acid by inhibiting the enzyme system responsible for acid secretion. The product also is indicated for the short-term treatment of active benign gastric ulcers; short-term and maintenance treatment of active duodenalulcers; short-term and maintenance treatment of erosive esophagitis, a condition in which the lining of the esophagus becomes inflamed and slowly deteriorates; and long-term treatment of Zollinger-Ellison syndrome, which involves the overproduction of stomach acid. TAP Holdings Inc., the parent company of TAP Pharmaceuticals Inc., is a joint venture between Abbott Laboratories, headquartered in Abbott Park, Illinois, and Takeda Chemical Industries, Ltd., of Osaka, Japan.
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