Adenoma Prevention with Celecoxib ( APC ) study investigators reviewed all potentially serious cardiovascular events among 2035 patients with a history of colorectal neoplasia who were enrolled in a trial comparing two doses of Celecoxib ( 200 mg or 400 mg twice daily ) with placebo for the prevention of colorectal adenomas.

The follow-up period for all surviving patients was 2.8 to 3.1 years.

A composite cardiovascular end point of death from cardiovascular causes, myocardial infarction, stroke, or heart failure was reached in 1 percent of patients in the placebo group, as compared with 2.3 percent of patients receiving 200 mg of Celecoxib twice daily and with 3.4 percent of patients receiving 400 mg of Celecoxib twice daily.

On the basis of these observations, the Data and Safety Monitoring Board recommended early discontinuation of the study drug.

According to results Celecoxib was associated with a dose-related increase in the composite end point of death from cardiovascular causes, myocardial infarction, stroke, or heart failure.

These data provide further evidence that the use of COX-2 inhibitors may increase the risk of serious cardiovascular events.

Source: The New England Journal of Medicine, 2005


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