Selective cyclooxygenase-2 inhibitors have come under scrutiny because of reports suggesting an increased cardiovascular risk associated with their use.
Experimental research suggesting that these drugs may contribute to a prothrombotic state provides support for this concern.
Dr Solomon and colleagues reviewed all potentially serious cardiovascular events among 2,035 patients with a history of colorectal neoplasia.
The researchers enrolled the patients in a trial comparing two doses of celecoxib (200 mg or 400 mg twice daily) with placebo for the prevention of colorectal adenomas.
All deaths were categorized by the investigators as cardiovascular or noncardiovascular, and nonfatal cardiovascular events were categorized in a blinded fashion according to a prespecified scheme.
The research team had about 3 years of follow-up data available for all patients except those who died.
|Based on the observations, the data and safety monitoring board recommended early discontinuation of the study drug
|New England Journal of Medicine|
The team reported that a composite cardiovascular end point of death from cardiovascular causes, myocardial infarction, stroke, or heart failure was reached in 7 of 679 (1%) patients in the placebo group.
This composite end point is compared with 16 of 685 (2%) patients receiving 200 mg of celecoxib twice daily and with 23 of 671 (3%) patients receiving 400 mg of celecoxib twice daily.
The investigators observed similar trends for other composite end points.
On the basis of these observations, the data and safety monitoring board recommended early discontinuation of the study drug.
Dr Solomon concludes, “Celecoxib use was associated with a dose-related increase in the composite end point of death from cardiovascular causes, myocardial infarction, stroke, or heart failure.”
“In light of recent reports of cardiovascular harm associated with treatment with other agents in this class, these data provide further evidence that the use of cyclooxygenase-2 inhibitors may increase the risk of serious cardiovascular events."