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QUESTION: In patients with osteoarthritis (OA), does rofecoxib at doses of 25 and 50 mg/day cause fewer endoscopic gastroduodenal ulcers than ibuprofen?
Randomised (allocation concealed*), blinded (patients, clinicians, and outcome assessors),* placebo controlled trial with 24 week follow up.
33 clinical centres in the United States.
742 patients (mean age 62 y, 68% women, 83% white) ≥50 years of age with OA that had required non-steroidal anti-inflammatory drugs (NSAIDs) for ≥6 months. Exclusion criteria were active ulcers; inflammatory bowel disease; previous upper gastrointestinal (GI) surgery; pyloric obstruction; erosive oesophagitis; abnormal serum creatinine levels or clearance; faecal occult blood; unstable medical conditions; history of cancer or cerebrovascular events; bleeding diathesis; or need for anticoagulants, ticlopidine, corticosteroids, or aspirin. The intention to treat analysis included 93% of the patients.
Patients were allocated to 16 to 24 weeks of rofecoxib, 25 mg/day (n=195); rofecoxib, 50 mg/day (n=186); ibuprofen, 2400 mg/day (n=184); or placebo (n=177). Some other drugs were allowed …