Abstract | OBJECTIVE: To evaluate the role of common internal controls in a meta-analysis of the relative efficacy of cyclooxygenase 2-selective inhibitors ( coxibs) in the treatment of osteoarthritis (OA). METHODS: A systematic search of Medline and US Food and Drug Administration electronic databases was performed to identify randomized, placebo-controlled clinical trials of coxibs ( etoricoxib, celecoxib, rofecoxib, valdecoxib) in patients with hip and/or knee OA. The effect size for coxibs and common active internal controls (nonsteroidal antiinflammatory drugs [ NSAIDs], naproxen) were determined by the mean changes from baseline in Western Ontario and McMaster Universities Osteoarthritis Index pain subscores as compared with placebo. RESULTS: The effect size for all coxib groups combined (0.44) indicated greater efficacy as compared with placebo, but significant heterogeneity (P < 0.0001) was observed. Rofecoxib at dosages of 12.5 mg/day and 25 mg/day and etoricoxib at a dosage of 60 mg/day had similar effect sizes (0.68 and 0.73, respectively), but these effect sizes were comparatively greater than those for both celecoxib at dosages of 200 mg/day and 100 mg twice daily or valdecoxib at a dosage of 10 mg/day (0.26 and 0.16, respectively). The effect sizes for NSAIDs or naproxen versus placebo, as determined using data from rofecoxib/ etoricoxib trials, were consistently higher than the effect sizes derived from trials of celecoxib/ valdecoxib. Significant heterogeneity was present in the overall effect size for NSAIDs (P = 0.007) and naproxen (P = 0.04) groups based on data available from all coxib trials. CONCLUSION:
Coxibs and common active internal controls showed larger effect sizes versus placebo in the rofecoxib/ etoricoxib trials than in the celecoxib/ valdecoxib trials. These findings suggest systematic differences among published coxib trials and emphasize the need for direct-comparison trials. In the absence of such trials, common internal controls should be assessed when performing indirect meta-analytic comparisons.
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Authors | Chin Lee, Elke Hunsche, Robert Balshaw, Sheldon X Kong, Thomas J Schnitzer |
Journal | Arthritis and rheumatism
(Arthritis Rheum)
Vol. 53
Issue 4
Pg. 510-8
(Aug 15 2005)
ISSN: 0004-3591 [Print] United States |
PMID | 16082648
(Publication Type: Journal Article, Research Support, N.I.H., Extramural, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Cyclooxygenase Inhibitors
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Topics |
- Anti-Inflammatory Agents, Non-Steroidal
(therapeutic use)
- Cyclooxygenase Inhibitors
(therapeutic use)
- Humans
- Meta-Analysis as Topic
- Osteoarthritis
(drug therapy)
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