Tuesday, March 14, 2006

Plavix and the Charisma study

CHARISMA stands for Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilisation, Managment and Avoidance. The PIs are Dr E.Topol and Dr D. Bhatt. They studied 15,603 patients and divided them into the group that received Clopidogrel and aspirin and the control group which had aspirin and a placebo. Clopidogrel is the generic name for Plavix.

Patients studied were also divided in two groups. One group were patients with manifest cardiovascular disease. These patients has either a previous MI, stroke or peripheral vascular disease. The other group had high coronary risk factors including diabetes, but no manifest cardiovascular disease.

At the end of 28months followup, the rates of cardiac death, heart attack and stroke was 7.3% in the aspirin+placebo group and 6.8% in the clopidogrel+aspirin group. When you subanalyse the 12,153 patients with manifest cardiovascular disease, the rates of cardiac death, heart attacks and strokes was 7.9% in the placebo+aspirin group and 6.9% in the clopidogrel+aspirin group. This was statiscally significant.

What this means is that if you give your patients with manifest disease clopidogrel and aspirin, you are helping them. But if you give clopidogrel and aspirin to patients at high risk of cardiovascular disease but not yet with manifest disease, then you may not be helping them. There was a slighly higher risk of bleeding with clopidogrel and aspirin.

The effects of this study may not be only felt by your patients, but also in the stock market.
As of yesterday BMS is still trading at its highest since November of last year but time will tell if there is a price to be paid for this finding.

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