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Misoprostol Compared with Sucralfate in the Prevention of Nonsteroidal Anti-inflammatory Drug-induced Gastric Ulcer: A Randomized, Controlled Trial

Naurang M. Agrawal, MD; Sanford Roth, MD; David Y. Graham, MD; Richard H. White, MD; Bernard Germain, MD; Jeffry A. Brown, MD; and Scott C. Stromatt, MD
[+] Article, Author, and Disclosure Information

This study represents the work of a nationwide study group, which, in addition to the authors, includes the following investigators: Richard Aaronson, MD, Chicago Heights, Illinois; Alphonso Belsito, MD, Bradenton, Florida; Jacques R. Caldwell, MD, Gainesville, Florida; Don E. Cheatum, MD, Dallas, Texas; Robert E. Ettlinger, MD, Tacoma, Washington; Edward Fudman, MD, Austin, Texas; Oren B. Gum, MD, New Orleans, Louisiana; Richard Jaszewski, MD, Allen Park, Michigan; Abraham Kolodny, MD, Baltimore, Maryland; Pamela Prete, MD, Long Beach, California; Martin Lidsky, MD, Houston, Texas; Jeffrey Lisse, MD, Galveston, Texas; Maren Mahowald, MD, Minneapolis, Minnesota; R. K. Marwah, MD, El Paso, Texas; Ronald Messner, MD, Minneapolis, Minnesota; Jehangir Rao, MD, Wayne, Michigan; William Tatum, MD, Oklahoma City, Oklahoma; Elizabeth Tindall, MD, Portland, Oregon; Robert Trapp, MD, Springfield, Illinois; J. P. Waring, MD, Phoenix, Arizona.

Grant Support: By a grant from G. D. Searle & Company, which provided the study design and data analyses.

Current Author Addresses: Dr. Agrawal: Tulane University School of Medicine, Section of Gastroenterology, 1430 Tulane Avenue, New Orleans, LA 70112.

Dr. Brown: University of Illinois Medical Center, 1740 W. Taylor, Chicago, IL 60612.

Dr. Germain: University of South Florida Medical Center, Division of Rheumatology, 12901 Bruce B. Downs Boulevard, Box 19, Tampa, FL 33612.

Dr. Graham: Baylor Health Science Center/Veterans Affairs Medical Center, 2002 Holcombe Boulevard (HID), Houston, TX 77211.

Dr. Roth: Arizona Arthritis Research & Education, Ltd., 3330 North 2nd Street, Phoenix, AZ 85012.

Dr. Stromatt: Chicago Medical School, 3333 Green Bay Road, North Chicago, IL 60064.

Dr. White: University of California, Davis, Department of Internal Medicine, 2221 Stockton Boulevard, Sacramento, CA 95817.

Ann Intern Med. 1991;115(3):195-200. doi:10.7326/0003-4819-115-3-195
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Objectives: To compare the efficacy and frequency of adverse experiences of misoprostol and sucralfate in the prevention of gastric ulcers in patients receiving nonsteroidal anti-inflammatory drug (NSAID) therapy.

Design: A prospective, randomized, single-blind, multicenter trial.

Patients: Patients with osteoarthritis receiving treatment with Ibuprofen, piroxicam, or naproxen and experiencing abdominal pain were eligible.

Interventions: Patients who were expected to receive at least 3 months of NSAID therapy and who did not have a gastric ulcer at the time of the initial screening endoscopy were randomized to receive misoprostol, 200 µg four times a day, or sucralfate, 1 g four times a day. A gastric ulcer was defined as a lesion of the gastric mucosa 0.3 cm or greater in diameter. Patients were followed clinically, and repeat endoscopies were performed after 4, 8, and 12 weeks.

Main Measurement: The development of a gastric ulcer, which was regarded as a prophylaxis failure.

Results: Two hundred fifty-three patients were evaluable for efficacy analysis. A gastric ulcer developed in 2 of the 122 (1.6%, 95% Cl, 0.3% to 6.4%) patients on misoprostol, compared with 21 of 131 patients on sucralfate (16%, Cl, 10.4% to 23.7%). The difference in ulcer rates was 14.4% (Cl, 10.4% to 19.5%; P < 0.001).

Conclusion: In patients receiving chronic NSAID therapy for osteoarthritis, treatment with misoprostol for 3 months was associated with a significantly lower frequency of gastric ulcer formation, compared with treatment with sucralfate (P < 0.001).





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