Naurang M. Agrawal, MD; Sanford Roth, MD; David Y. Graham, MD; Richard H. White, MD; Bernard Germain, MD; Jeffry A. Brown, MD; Scott C. Stromatt, MD
▪ 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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Agrawal NM, Roth S, Graham DY, White RH, Germain B, Brown JA, et al. Misoprostol Compared with Sucralfate in the Prevention of Nonsteroidal Anti-inflammatory Drug-induced Gastric Ulcer: A Randomized, Controlled Trial. Ann Intern Med. 1991;115:195-200. doi: 10.7326/0003-4819-115-3-195
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Published: Ann Intern Med. 1991;115(3):195-200.
Gastroenterology/Hepatology, Peptic Disease, Peptic Ulcer.
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