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.
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Graham DY, White RH, Moreland LW, Schubert TT, Katz R, Jaszewski R, 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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