Controversies With COX-2 Inhibitors
Rofecoxib was shown to produce significantly fewer gastrointestinal ADRs compared with naproxen. This study, the VIGOR trial, raised the issue of the cardiovascular safety of the coxibs. A statistically insignificant increase in the incidence of myocardial infarctions was observed in patients on rofecoxib. Further data, from the APPROVe trial, showed a statistically significant relative risk of cardiovascular events of 1.97 versus placebo—which caused a worldwide withdrawal of rofecoxib in October 2004.
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