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| The combination of clopidogrel and aspirin show no benefit compared aspirin mono therapy in the reduction of CVD events – Results of the CHARISMA trial |
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14 March 2006
In patients at high risk for atherothrombotic events, the combination of clopidogrel and aspirin proved no better than aspirin alone at reducing rates of myocardial infarctions, stroke, or cardiovascular-related deaths. In addition to finding no significant benefit for the combination in a randomised trial in more than 15,000 patients, clopidogrel plus aspirin for patients with multiple risk factors was associated with increased risk for moderate and serious bleeding, investigators reported at the 55th Annual Scientific Session of the American College of Cardiology (ACC) in Atlanta, March 11–14, 2006.
The combination of clopidogrel and aspirin nearly doubled the risk for death from cardiovascular causes for these high-risk asymptomatic patients compared with humble aspirin alone, said Dr Deepak Bhatt of the Cleveland Clinic, speaking for colleagues in the CHARISMA (Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance) trial.
15,603 patients with either clinically evident cardiovascular disease or multiple risk factors were randomly assigned to receive clopidogrel (75 mg per day) plus low-dose aspirin (75 to 162 mg per day) or placebo plus low-dose aspirin and followed them for a median of 28 months. The primary efficacy end point was a composite of
myocardial infarction, stroke, or death from cardiovascular causes.
The rate of the primary efficacy end point was 6.8% with clopidogrel plus aspirin and 7.3% with placebo plus aspirin (relative risk, 0.93; 95% confidence interval, 0.83 to 1.05; p=0.22). The respective rate of the principal secondary efficacy end point, which included hospitalisations for ischaemic events, was 16.7% and 17.9% (relative risk, 0.92; 95% confidence interval, 0.86 to 0.995; p=0.04), and the rate of severe bleeding was 1.7% and 1.3% (relative risk, 1.25; 95% confidence interval, 0.97 to 1.61%; p=0.09). The rate of the primary end point among patients with multiple risk factors was 6.6% with clopidogrel and 5.5% with placebo (relative risk, 1.2; 95% confidence interval, 0.91 to 1.59; p=0.20) and the rate of death from cardiovascular causes also was higher with clopidogrel (3.9% vs. 2.2%, p=0.01). In the subgroup with clinically evident atherothrombosis, the rate was 6.9% with clopidogrel and 7.9% with placebo (relative risk, 0.88; 95% confidence interval, 0.77 to 0.998; p=0.046).
The findings do not support the use of dual antiplatelet therapy across the broad population tested, Dr. Bhatt said. Along with presentation at the ACC, the CHARISMA trial results were published in the online edition of the New England Journal of Medicine.
Reference:
N Engl J Med 2006; 354: ahead of print.
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