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 language | English (US) |
|---|---|
| Pages (from-to) | 195-200 |
| Number of pages | 6 |
| Journal | Annals of Internal Medicine |
| Volume | 115 |
| Issue number | 3 |
| State | Published - Aug 1 1991 |
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ASJC Scopus subject areas
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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 journal › Article
}
TY - JOUR
T1 - Misoprostol compared with sucralfate in the prevention of nonsteroidal anti-inflammatory drug-induced gastric ulcer
T2 - A randomized, controlled trial
AU - Agrawal, Naurang M.
AU - Roth, Sanford
AU - Graham, David Y.
AU - White, Richard H
AU - Germain, Bernard
AU - Brown, Jeffry A.
AU - Stromatt, Scott C.
PY - 1991/8/1
Y1 - 1991/8/1
N2 - 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).
AB - 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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M3 - Article
C2 - 1905501
AN - SCOPUS:0025737891
VL - 115
SP - 195
EP - 200
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
SN - 0003-4819
IS - 3
ER -