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New APPROVe data confirm Vioxx cardiovascular risk
In September 2004 the APPROVe (Adenomatous Polyp Prevention on Vioxx) trial was stopped early owing to concerns about increased cardiovascular mortality in patients taking the drug. An analysis of the long-term outcomes of the patients in the trial has now been published in the Lancet.
After the early termination of the trial, all 2587 participants were followed up for at least 1 year after stopping treatment. The investigators examined the incidence of non-fatal myocardial infarction and stroke, and also deaths from cardiovascular, haemorrhagic, or unknown causes.
Post-treatment cardiovascular follow-up data were available from 84% of patients and extended mortality follow-up from 95%. Overall, 59 patients in the rofecoxib group and 34 in the placebo group had one of the prespecified events (p = 0.06). In the first year after treatment with rofecoxib, there was a non-significant increase in the risk of these end points, although the hazard ratio did not change over time.
Although the number of outcomes available for analysis in this trial was small, the two ”take-home” messages from this trial are:
the risk associated with rofecoxib use could be seen early;
the risk persisted over the course of a year.
Nonetheless, it should be recalled that non-steroidal anti-inflammatory drug treatment is also associated with increased cardiovascular risk, and the p value in the above paper is marginal. Therefore doctors choosing an anti-inflammatory drug must try to balance the risks and benefits of a chosen treatment for their patient.
▸ Baron JA, Sandler RS, Bresalier RS, . Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial. Lancet 2008;372:1756–64.
▸ Baigent C, Patrono C. Selective COX-2 inhibitors: where do we go from here? Lancet 2008;372:1712–3.
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