Duodenal and gastric ulcer prevention with misoprostol in arthritis patients taking NSAIDs

David Y. Graham, Richard H White, Larry W. Moreland, Timothy T. Schubert, Robert Katz, Richard Jaszewski, Elizabeth Tindall, George Triadafilopoulos, Scott C. Stromatt, Leah S. Teoh

Research output: Contribution to journalArticle

262 Scopus citations

Abstract

Objectives: To determine the efficacy of misoprostol for the prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced duodenal and gastric ulcers in arthritis patients receiving NSAID therapy. Design: A randomized, double-blind, multicenter, placebo-controlled trial. ■ Setting: Six hundred thirty-eight private, Veterans Affairs, health maintenance, and academic practices. Patients: Six hundred thirty-eight patients with chronic inflammatory or noninflammatory arthritis who were taking an NSAID but who did not have a gastric or duodenal ulcer on screening endoscopy received treatment with ibuprofen, piroxicam, naproxen, sulindac, tolmetin, indomethacin, or diclofenac daily for 3 months. Four hundred fifty-five (71%) patients completed the trial. Interventions: Patients meeting the entry criteria were randomized to receive either misoprostol, 200 μg, or placebo, four times a day for 12 weeks. Main Outcome Measures: The endoscopy was repeated at 4, 8, and 12 weeks. The development of a duodenal or gastric ulcer (defined as a circumscribed mucosal defect ≥;0.5 cm in diameter and with perceptible depth) was regarded as prophylactic failure. Results: By 12 weeks, a duodenal ulcer developed in 2 of 320 (0.6%; 95% Cl, 0.2% to 3.9%) patients randomized to receive misoprostol, compared with 15 of 323 (4.6%; Cl, 2.8% to 8%) patients receiving placebo (P = 0.002). A gastric ulcer developed in 6 of 320 (1.9%; (Cl, 0.8% to 4.4%) patients, compared with in 25 of 323 (7.7%; Cl, 5.1% to 11.4%), respectively. Conclusion: Misoprostol significantly lowers the frequency of both duodenal and gastric ulcer development in patients who require long-term therapy with NSAIDS.

Original languageEnglish (US)
Pages (from-to)257-262
Number of pages6
JournalAnnals of Internal Medicine
Volume119
Issue number4
StatePublished - Aug 15 1993
Externally publishedYes

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ASJC Scopus subject areas

  • Medicine(all)

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Graham, D. Y., White, R. H., Moreland, L. W., Schubert, T. T., Katz, R., Jaszewski, R., Tindall, E., Triadafilopoulos, G., Stromatt, S. C., & Teoh, L. S. (1993). Duodenal and gastric ulcer prevention with misoprostol in arthritis patients taking NSAIDs. Annals of Internal Medicine, 119(4), 257-262.