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Vol 276 No 7392 p312
18 March 2006

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CHARISMA study clarifies when to use clopidogrel

Clopidogrel (Plavix) plus low-dose aspirin reduces cardiovascular events and deaths in patients with vascular disease compared with aspirin alone, a new study confirms. The study, which clarifies when to use dual antiplatelet therapy, reveals that clopidogrel does not provide the same benefit for patients with risk factors but no documented disease.

The CHARISMA (clopidogrel for high atherothrombotic risk and ischemic stabilization management and avoidance) study randomised 15,603 patients with previous cardiovascular or peripheral arterial disease or multiple risk factors to daily clopidogrel (75 mg) or placebo, plus aspirin (75–162mg). Results were reported at the American College of Cardiology annual scientific session in Atlanta, Georgia, this week and online in The New England Journal of Medicine (12 March).

They show the rate of myocardial infarction, stroke, or death from cardiovascular causes in the subgroup of more than 12,000 patients with established vascular disease was reduced by 12.5 per cent (6.9 per cent with clopidogrel versus 7.9 per cent with placebo; P=0.046) after a median follow-up of 28 months. However, patients with risk factors but no documented disease showed no reduction, with a trend to increased risk of events (6.6 per cent with clopidogrel versus 5.5 per cent with placebo; P=0.20). This dichotomy meant that results for the entire group did not reach significance (6.8 per cent versus 7.3 per cent; P=0.22).

The lead investigator, Deepak Bhatt, Cleveland Clinic, Ohio, said: “The findings confirmed previous studies showing benefit with clopidogrel plus aspirin in patients with symptomatic atherothrombosis but showed the potential harm outweighed the benefit in those who only had risk factors.”

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