Clopidogrel Plus Aspirin No Better Than Aspirin Alone

CHARISMA trial finds no overall benefit but possible benefits and risks for certain patients

MONDAY, March 13 (HealthDay News) -- Clopidogrel plus aspirin is not significantly more effective than aspirin alone in reducing adverse cardiovascular events, according to a study released early online March 12 by the New England Journal of Medicine to coincide with the American College of Cardiology conference in Atlanta.

For the CHARISMA trial, Deepak L. Bhatt, M.D., of the Cleveland Clinic in Ohio, and colleagues randomly assigned 15,603 patients with either clinically evident cardiovascular disease or multiple risk factors to receive clopidogrel plus low-dose aspirin or placebo plus low-dose aspirin.

For the primary efficacy end point -- a composite of myocardial infarction, stroke or death from cardiovascular causes -- the researchers found an overall rate of 6.8 percent with clopidogrel and 7.3 percent with placebo. Among patients with clinically evident cardiovascular disease, the rate was 6.9 percent with clopidogrel and 7.9 percent with placebo. Among patients with multiple risk factors, the rate was 6.6 percent with clopidogrel and 5.5 percent with placebo.

"Admittedly, this 'one-size-fits-all' approach leaves much to be desired," states the author of an accompanying editorial. "However, more homogeneous genotypic and phenotypic (pathophysiological) characterization of patients will be required before clinical trials can be 'personalized.' Until then, the charisma of extracting favorable P values from subgroups should be resisted and dual antiplatelet therapy avoided in these patients with stable disease."

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