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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: Dr Mukherjee and colleagues1 concluded that COX-2 inhibitors may be associated with an increased risk of CV events. We believe that the analysis provides no substantive support for their conclusion.

The authors' conclusion was heavily influenced by the findings of VIGOR,2 a randomized, controlled comparison of rofecoxib vs naproxen. This study yielded an unanticipated differential in CV events, favoring naproxen. There are several possible explanations, including a protective effect resulting from the antiplatelet action of naproxen,3 or an adverse effect of rofecoxib. The best way to distinguish these possibilities is to examine data with comparators other than naproxen. Konstam et al4 recently reported a pooled analysis of the occurrence of thrombotic events in more than 28 000 patients randomized to rofecoxib, placebo, or nonselective NSAIDs. In contrast to the comparison with naproxen, comparisons with placebo (n = 9772) and with NSAIDs other than naproxen (n = 7304) showed no excess of CV events with rofecoxib. In these analyses, the placebo-controlled data were derived largely from patient populations with substantial cardiovascular risk. These findings support a protective effect of naproxen as the most likely explanation for the unexpected findings in VIGOR.

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