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Therapeutics
Rofecoxib caused fewer endoscopic gastroduodenal ulcers than ibuprofen in osteoarthritis

https://doi.org/10.1136/ebm.5.3.74

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    (1999) Gastroenterology 117, 776. Laine L, Harper S, Simon T, et al,. for the Rofecoxib Osteoarthritis Endoscopy Study Group.. A randomized trial comparing the effect of rofecoxib, a cyclooxygenase 2-specific inhibitor, with that of ibuprofen on the gastroduodenal mucosa of patients with osteoarthritis.. Oct;. :. –83.
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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?

    Design

    Randomised (allocation concealed*), blinded (patients, clinicians, and outcome assessors),* placebo controlled trial with 24 week follow up.

    Setting

    33 clinical centres in the United States.

    Patients

    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.

    Intervention

    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 …

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    Footnotes

    • Source of funding: Merck & Co., Inc.

    • For correspondence: Dr L Laine, GI Liver Division, Department of Medicine (LAC 12-137), University of Southern California School of Medicine, 2025 Zonal Avenue, Los Angeles, CA 90033, USA. Fax +1 323 226 7573.

    • ↵* See glossary.