Key result
Rofecoxib significantly reduced the incidence of upper gastrointestinal perforations, ulcers, and bleeding compared to NSAIDs over 24.8 months (1.6% vs 3.1%; RR 0.36; 95% CI 0.24-0.54; p<0.001).
Why the study?
Does rofecoxib reduce upper GI perforations, symptomatic gastroduodenal ulcers, and upper GI bleeding compared to non-selective NSAIDs in patients with osteoarthritis or rheumatoid arthritis?
Population
17,072 men and women with osteoarthritis or rheumatoid arthritis from multinational trial sites.
Comparison
Rofecoxib 12.5 mg, 25 mg, or 50 mg vs Non-selective NSAIDs
Design
Meta-analysis, randomized, double-blind
Follow-up
24.8 months
Authors
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Supports rofecoxib preference for GI safety in high-risk arthritis patients; confirms pooled RCT evidence for COX-2 selectivity benefits.
Meta-Analysis (n=17,072)
double-blind
randomized
Yes
Does rofecoxib reduce upper GI perforations, symptomatic gastroduodenal ulcers, and upper GI bleeding compared to non-selective NSAIDs in patients with osteoarthritis or rheumatoid arthritis?
Relative Risk: 0.36 (95% CI 0.24–0.54)
Absolute Event Rate: 1.6% vs 3.1%
p-value: p=<0.001
In a combined analysis of 20 trials, rofecoxib significantly reduced the risk of upper gastrointestinal perforations, ulcers, and bleeding compared to non-selective NSAIDs.
Watson et al. (2004) conducted a meta-analysis in osteoarthritis or rheumatoid arthritis (n=17,072). Rofecoxib vs. NSAIDs (ibuprofen, diclofenac, nabumetone, or naproxen) was evaluated on confirmed upper GI perforations, symptomatic gastroduodenal ulcers, and upper GI bleeding (PUBs) (RR 0.36, 95% CI 0.24-0.54, p=<0.001). Rofecoxib significantly reduced the incidence of upper gastrointestinal perforations, ulcers, and bleeding compared to NSAIDs over 24.8 months (1.6% vs 3.1%; RR 0.36; 95% CI 0.24-0.54; p<0.001).
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