More COX-2 meta-analysis
Executive Summary
A meta-analysis of observational studies of selective and non-selective inhibitors of COX-2 published online in JAMA Sept. 12 finds that increased cardiovascular risk with Merck's Vioxx (rofecoxib) "could be observed during the first 30 days of treatment." Authors Patricia McGettigan and David Henry (University of New South Wales) note that "this conclusion is consistent with a recent re-analysis of the APPROVe trial of rofecoxib, which contradicts the original suggestion that the vascular risk was only seen after 18 months of treatment." Merck says finding is "not supported by the current weight of the clinical trial data." Meta-analysis also finds non-selective agent diclofenac increases risk of cardiovascular events (relative risk 1.63). Authors say findings are "grounds for reviewing [diclofenac's] regulatory status." Diclofenac was the comparator in a cardiovascular safety trial of Merck's Vioxx follow-on Arcoxia (etoricoxib) (1"The Pink Sheet" Aug. 28, 2006, p. 5). An accompanying editorial by FDA Associate Director for Science David Graham says the two analyses published in JAMA "provide clarity" on COX-2 safety...
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