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


METHODS
A prospective, randomized, single-blind, multicenter trial.


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


METHODS
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 micrograms 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.


METHODS
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% CI, 0.3% to 6.4%) patients on misoprostol, compared with 21 of 131 patients on sucralfate (16%, CI, 10.4% to 23.7%). The difference in ulcer rates was 14.4% (CI, 10.4% to 19.5%; P less than 0.001).


CONCLUSIONS
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 less than 0.001).
Agrawal
N M
NM
Tulane University School of Medicine, New Orleans, Louisiana.
Roth
S
S
Graham
D Y
DY
White
R H
RH
Germain
B
B
Brown
J A
JA
Stromatt
S C
SC
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000527:Alprostadil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000536:Aluminum Hydroxide / Q000627:therapeutic use; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000037:antagonists & inhibitors*; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015993:Life Tables; D008297:Male; D008875:Middle Aged; D016595:Misoprostol; D010003:Osteoarthritis / Q000188:drug therapy; D011446:Prospective Studies; D016037:Single-Blind Method; D013223:Statistics as Topic; D013276:Stomach Ulcer / Q000139:chemically induced / Q000517:prevention & control*; D013392:Sucralfate / Q000009:adverse effects / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D016595:Misoprostol; D013392:Sucralfate; D000536:Aluminum Hydroxide; D000527:Alprostadil