OMEPRAZOLE COMPARED WITH MISOPROSTOL FOR ULCERS ASSOCIATED WITH NONSTEROIDAL ANTIINFLAMMATORY DRUGS

Background Misoprostol is effective for ulcers associated with the use of nonsteroidal antiinflammatory drugs (NSAIDs) but is often poorly t olerated because of diarrhea and abdominal pain. We compared the effic acy of omeprazole and misoprostol in healing and preventing ulcers ass ociated with NSAIDs. Methods In a double-blind study, we randomly assi gned 935 patients who required continuous NSAID therapy and who had ul cers 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 mu g of misoprostol orally four times daily. Patients were treated for fou r weeks or, in the absence of healing, eight weeks. Treatment success was defined as the absence of ulcers and the presence of fewer than fi ve erosions at each site and not more than mild dyspepsia. We then ran domly reassigned 732 patients in whom treatment was successful to main tenance therapy with 20 mg of omeprazole daily, 200 mu g of misoprosto l twice daily, or placebo for six months. Results At eight weeks, trea tment was successful in 76 percent of the patients given 20 mg of omep razole (233 of 308), 75 percent of those given 40 mg of omeprazole (23 7 of 315), and 71 percent of those given misoprostol (212 of 298). The rates of gastric-ulcer healing were significantly higher with 20 mg o f omeprazole (but not 40 mg of omeprazole) than with misoprostol. Heal ing 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. More patien ts remained in remission during maintenance treatment with omeprazole (61 percent) than with misoprostol (48 percent, P=0.001) and with eith er drug than with placebo (27 percent, P<0.001). There were more adver se events during the healing phase in the misoprostol group than in th e groups given 20 mg and 40 mg of omeprazole (59 percent, 48 percent, and 46 percent, respectively). Conclusions The overall rates of succes sful treatment of ulcers, erosions, and symptoms associated with NSAID s were similar for the two doses of omeprazole and misoprostol. Mainte nance therapy with omeprazole was associated with a lower rate of rela pse than misoprostol. Omeprazole was better tolerated than misoprostol . (C)1998, Massachusetts Medical Society.