Misoprostol and ranitidine in the prevention of NSAID-induced ulcers: A prospective, double-blind, multicenter study

Jeffrey B. Raskin, Richard H. White, Richard Jaszewski, Mark A. Korsten, Timothy T. Schubert, John G. Fort

Research output: Contribution to journalArticlepeer-review

110 Scopus citations

Abstract

Objective: To compare ranitidine to misoprostol with respect to the prevention of gastric and duodenal ulcers in patients on chronic NSAID therapy. 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 endoscopic evidence of gastric or duodenal ulcers. Patients enrolled in the study were randomized to either misoprostol 200 μg q.i.d. or ranitidine 150 mg b.i.d.. Follow-up UGI endoscopy was performed after 4 and 8 wk of treatment. Therapeutic failure was considered the development of a gastric or duodenal ulcer ≥ 0.3 cm in diameter with perceptible depth. Results: Gastric ulcers were found in only 1/180 (0.56%) patient on misoprostol and in 11/194 (5.67%) patients on ranitidine, a difference that was statistically significant (p < 0.01). Duodenal ulcer rates were similar for the ranitidine (2/185 or 1.08%) and misoprostol (2/ 181 or 1.10%) groups. Conclusion: Misoprostol is significantly more effective than ranitidine in the prevention of NSAID-induced 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.

Original languageEnglish (US)
Pages (from-to)223-227
Number of pages5
JournalAmerican Journal of Gastroenterology
Volume91
Issue number2
StatePublished - Feb 1 1996

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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