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December 12, 2001

Cardiovascular Events and COX-2 Inhibitors

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor

JAMA. 2001;286(22):2808-2813. doi:10.1001/jama.286.22.2808

To the Editor: The meta-analysis by Dr Mukherjee and colleagues1 compared the risk of MI of the selective COX-2 inhibitors rofecoxib and celecoxib from data2,3 reported to the US Food and Drug Administration with that of placebo from a meta-analysis of aspirin for primary prevention.4 The results of this analysis showed that the annualized MI rate was higher with both rofecoxib and celecoxib compared with placebo (0.74%, 0.80%, and 0.52%, respectively; P = .04 and P = .02 for rofecoxib and celecoxib vs placebo, respectively).1 However, Mukherjee et al did not present the results for the 3 nonselective COX-2 inhibitors relative to placebo. The VIGOR5 and CLASS6 studies found the annualized MI rates for naproxen, ibuprofen, and diclofenac to be 0.15%, 0.80%, and 0.40%, respectively. Did the authors determine the level of statistical significance between the rates for these medications and placebo?

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