Misoprostol compared with sucralfate in the prevention of nonsteroidal anti-inflammatory drug-induced gastric ulcer: A randomized, controlled trial

Naurang M. Agrawal, Sanford Roth, David Y. Graham, Richard H White, Bernard Germain, Jeffry A. Brown, Scott C. Stromatt

Research output: Contribution to journalArticle

180 Citations (Scopus)

Abstract

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).

Original languageEnglish (US)
Pages (from-to)195-200
Number of pages6
JournalAnnals of Internal Medicine
Volume115
Issue number3
StatePublished - Aug 1 1991

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Sucralfate
Misoprostol
Stomach Ulcer
Anti-Inflammatory Agents
Randomized Controlled Trials
Pharmaceutical Preparations
Drug Therapy
Osteoarthritis
Endoscopy
Piroxicam
Naproxen
Ibuprofen
Gastric Mucosa
Abdominal Pain
Multicenter Studies
Ulcer
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

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Misoprostol compared with sucralfate in the prevention of nonsteroidal anti-inflammatory drug-induced gastric ulcer : A randomized, controlled trial. / Agrawal, Naurang M.; Roth, Sanford; Graham, David Y.; White, Richard H; Germain, Bernard; Brown, Jeffry A.; Stromatt, Scott C.

In: Annals of Internal Medicine, Vol. 115, No. 3, 01.08.1991, p. 195-200.

Research output: Contribution to journalArticle

Agrawal, Naurang M. ; Roth, Sanford ; Graham, David Y. ; White, Richard H ; Germain, Bernard ; Brown, Jeffry A. ; Stromatt, Scott C. / Misoprostol compared with sucralfate in the prevention of nonsteroidal anti-inflammatory drug-induced gastric ulcer : A randomized, controlled trial. In: Annals of Internal Medicine. 1991 ; Vol. 115, No. 3. pp. 195-200.
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abstract = "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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