MISOPROSTOL AND RANITIDINE IN THE PREVENTION OF NSAID-INDUCED ULCERS - A PROSPECTIVE, DOUBLE-BLIND, MULTICENTER STUDY

Objective: To compare ranitidine to misoprostol with respect to the pr evention of gastric and duodenal ulcers in patients on chronic NSAID t herapy. Methods: A multi-center, 8-wk, randomized, double-blind study, Eligible patients were on chronic NSAID therapy and were experiencing NSAID-related upper gastrointestinal (UGI) pain without UGI endoscopi c evidence of gastric or duodenal ulcers, Patients enrolled in the stu dy were randomized to either misoprostol 200 mu g q.i.d or ranitidine 150 mg b.i.d. Follow-up UGI endoscopy was performed after 4 and 8 wk o f treatment. Therapeutic failure was considered the development of a g astric or duodenal ulcer equal to or greater than 0.3 cm in diameter w ith perceptible depth. Results: Gastric ulcers were found in only 1/18 0 (0.56%) patient on misoprostol and in 11/194 (5.67%) patients on ran itidine, a difference that was statistically significant (p < 0.01), D uodenal ulcer rates were similar for the ranitidine (2/185 or 1.08%) a nd misoprostol (2/185 or 1.10%) groups. Conclusion: Misoprostol is sig nificantly more effective than ranitidine in the prevention of NSAID-i nduced gastric ulcers. Ranitidine was as effective as misoprostol for the prevention of NSAID-induced duodenal ulcers, Misoprostol should be used for prophylaxis against both gastric and duodenal ulceration in patients on chronic NSAID therapy.