CLINICAL ALERT
Omeprazole led to greater remission rate than misoprostol for ulcers associated with non-steroidal anti-inflammatory drugs
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Question
In patients with gastroduodenal ulcers associated with long term
non-steroidal anti-inflammatory drug (NSAID) use, is omeprazole more
effective than misoprostol for promoting and maintaining healing?
Design
6 month randomised, double blind, controlled trial.
Setting
93 clinical centres in 14 countries.
Patients
935 patients who were 18-85 years of age; had conditions that
required continuous treatment with at least a minimal dose of oral or
rectal NSAIDs; and had ulcers
3 mm in diameter in stomach, duodenum,
or both, or >10 gastric or duodenal erosions. Exclusion criteria were
reflux esophagitis, clinically important upper gastrointestinal bleeding, pyloric stenosis, history of gastric surgery, or
gastrointestinal disorders that could impair drug absorption. Follow up
was 99% (mean age 58 y, 63% women).
Intervention
Patients were allocated to omeprazole, 20 mg once/day (n=308) or
twice/day (n=315), or misoprostol, 200 µg 4 times/day (n=298). Patients whose ulcers were considered healed were allocated to 1 of 3 maintenance treatments: omeprazole, 20 mg/day (n=274);
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