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; Misoprostol Study Group.
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.
A randomized, double-blind, multicenter, placebo-controlled trial.
Six hundred thirty-eight private, Veterans Affairs, health maintenance, and academic practices.
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.
Patients meeting the entry criteria were randomized to receive either misoprostol, 200 g, or placebo, four times a day for 12 weeks.
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.
By 12 weeks, a duodenal ulcer developed in 2 of 320 (0.6%; 95% CI, 0.2% to 3.9%) patients randomized to receive misoprostol, compared with 15 of 323 (4.6%; CI, 2.8% to 8%) patients receiving placebo (P = 0.002). A gastric ulcer developed in 6 of 320 (1.9%; [CI, 0.8% to 4.4%] patients, compared with in 25 of 323 (7.7%; CI, 5.1% to 11.4%), respectively.
Misoprostol significantly lowers the frequency of both duodenal and gastric ulcer development in patients who require long-term therapy with NSAIDs.
David Y. Graham, Richard H. White, Larry W. Moreland, Timothy T. Schubert, Robert Katz, Richard Jaszewski, et al. Duodenal and Gastric Ulcer Prevention with Misoprostol in Arthritis Patients Taking NSAIDs. Ann Intern Med. 1993;119:257–262. doi: 10.7326/0003-4819-119-4-199308150-00001
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Published: Ann Intern Med. 1993;119(4):257-262.
Gastroenterology/Hepatology, Peptic Disease, Peptic Ulcer, Rheumatology.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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