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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, Misoprostol Study Group.
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From the Veterans Affairs Medical Center/Baylor College of Medicine, Houston, Texas; University of California, Davis, Sacramento, California; University of Alabama at Birmingham, Birmingham, Alabama; Henry Ford Hospital, Detroit, Michigan; Rush Presbyterian, St. Luke's Medical Center, Chicago, Illinois; Wayne State University School of Medicine/Veterans Affairs Medical Center, Allen Park, Michigan; Veterans Affairs Medical Center, Martinez, California; G.D. Searle. Requests for Reprints: David Y. Graham, MD, Digestive Disease Section (111D), Veterans Affairs Medical Center, 2002 Holcombe Boulevard, Houston, TX 77030. Acknowledgments: The authors thank Tamara Schiller for her valuable assistance. Grant Support: In part by a grant from G.D. Searle Company.


Copyright 2004 by the American College of Physicians


Ann Intern Med. 1993;119(4):257-262. doi:10.7326/0003-4819-119-4-199308150-00001
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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 g, 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% 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.

Conclusion: Misoprostol significantly lowers the frequency of both duodenal and gastric ulcer development in patients who require long-term therapy with NSAIDs.

Figures

Grahic Jump Location
Figure 1.
Percentage of evaluable and intent-to-treat patients with duodenal ulcers.PP

Among evaluable misoprostol-treated patients, 0.9% developed a duodenal ulcer compared with 6% in the placebo group ( = 0.004). Among intent-to-treat patients in the misoprostol group, 0.6% developed a duodenal ulcer compared with 4.6% in the placebo group ( = 0.003).

Grahic Jump Location
Grahic Jump Location
Figure 2.
Percentage of intention-to-treat patients developing ulcers during the 12-week study period.

The 95% CI for misoprostol and placebo groups, respectively: duodenal ulcer, 0.1% to 2.6% and 2.8% to 8%; gastric ulcer, 0.8% to 4.4%, and 5.1% to 11.4%; and gastroduodenal ulcer, 1.2% to 5.3% and 8.3% to 15.8%.

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