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3,4 Epidemiologic studies have estimated that the risks of gastropathy and death are 3 to 10 times as high 5-10 among patients who take NSAIDs regularly as among those who do not, and endoscopic studies have shown that the prevalence of peptic ulcers is 20 to 30 percent among regular users of NSAIDs. Nonsteroidal antiinflammatory drugs (NSAIDs) are widely used 1,2 but have substantial gastroduodenal toxicity and account for 21 to 25 percent of reported adverse reactions in patients taking these drugs in combination with other medications. Omeprazole was better tolerated than misoprostol.
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Maintenance therapy with omeprazole was associated with a lower rate of relapse than misoprostol. The overall rates of successful treatment of ulcers, erosions, and symptoms associated with NSAIDs were similar for the two doses of omeprazole and misoprostol. There were more adverse events during the healing phase in the misoprostol group than in the groups given 20 mg and 40 mg of omeprazole (59 percent, 48 percent, and 46 percent, respectively). More patients remained in remission during maintenance treatment with omeprazole (61 percent) than with misoprostol (48 percent, P = 0.001) and with either drug than with placebo (27 percent, P<0.001).
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Healing rates among patients with duodenal ulcers were higher with either dose of omeprazole than with misoprostol, whereas healing rates among patients with erosions alone were higher with misoprostol. The rates of gastric-ulcer healing were significantly higher with 20 mg of omeprazole (but not 40 mg of omeprazole) than with misoprostol. ResultsĪt eight weeks, treatment was successful in 76 percent of the patients given 20 mg of omeprazole (233 of 308), 75 percent of those given 40 mg of omeprazole (237 of 315), and 71 percent of those given misoprostol (212 of 298). We then randomly reassigned 732 patients in whom treatment was successful to maintenance therapy with 20 mg of omeprazole daily, 200 μg of misoprostol twice daily, or placebo for six months. Treatment success was defined as the absence of ulcers and the presence of fewer than five erosions at each site and not more than mild dyspepsia. Patients were treated for four weeks or, in the absence of healing, eight weeks. In a double-blind study, we randomly assigned 935 patients who required continuous NSAID therapy and who had ulcers or more than 10 erosions in the stomach or duodenum (or both) to receive 20 mg or 40 mg of omeprazole orally in the morning or 200 μg of misoprostol orally four times daily. We compared the efficacy of omeprazole and misoprostol in healing and preventing ulcers associated with NSAIDs. Misoprostol is effective for ulcers associated with the use of nonsteroidal antiinflammatory drugs (NSAIDs) but is often poorly tolerated because of diarrhea and abdominal pain. The most trusted, influential source of new medical knowledge and clinical best practices in the world.
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