Increased risk of cardiovascular events with parecoxib/valdecoxib: a systematic review and meta-analysis

To determine the risk of serious cardiovascular events associated with the use of the COX-2 inhibitor valdecoxib and its prodrug parecoxib following major surgery.

A systematic review and meta-analysis of placebo-controlled randomised double-blind clinical trials of IV parecoxib followed by oral valdecoxib treatment, that presented data on serious cardiovascular events. Studies were identified from six databases including Medline and the FDA website on parecoxib/valdecoxib. The main outcome measure was major cardiovascular events. The pooled fixed effects estimates for the odds ratio for risk of cardiovascular events for the use of parecoxib/valdecoxib were calculated using the inverse variance weighting method.

Three studies with a total of 2,604 subjects were included in the meta-analysis. Parecoxib/valdecoxib was associated with a significantly increased risk of major cardiovascular events, with an odds ratio of 2.3 (95% CI: 1.1-4.7).

There is an increased cardiovascular risk associated with parecoxib/valdecoxib therapy in the post-surgical situation. These findings are consistent with a class effect for COX-2 inhibitors increasing the risk of cardiovascular events.