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Stroke and Heart Attack Risk of Vioxx Confirmed

Long-term data compatible with earlier findings on rofecoxib and cardiovascular events

TUESDAY, Oct. 14 (HealthDay News) -- Long-term data confirms that use of the COX-2 inhibitor rofecoxib carries an increased risk of cardiovascular events, according to research published online Oct. 14 in The Lancet.

John A. Baron, M.D., of Dartmouth Medical School in Hanover, N.H., and colleagues report on data on cardiovascular outcomes from the Adenomatous Polyp Prevention on Vioxx study of 2,587 patients recruited from 108 centers worldwide. Cardiovascular data was available for 84 percent of the cohort, and extended mortality follow-up was available for 95 percent.

The analysis focused on the combined incidence of non-fatal myocardial infarction, non-fatal stroke, death from cardiovascular, hemorrhagic and unknown causes, the report indicates. In the rofecoxib group there were 59 individuals affected, versus 34 in the placebo group, the investigators found. The relative risk of cardiovascular events remained broadly the same over time, the data indicated.

"Small numbers prohibit detailed conclusions about when the increased risk begins and ends, but our data are compatible with an early increase in risk that seems to persist for about one year after three years of treatment," the authors write. "The cardiovascular toxicity seems to be a class effect; indeed, studies of other selective COX-2 inhibitors have reported similar findings."

The study was funded by Merck Research Laboratories.

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