New CURE data could add $1 billion-plus to clopidogrel sales

Sanofi-Synthelabo and Bristol-Myers Squibb's antiplatelet drugPlavix/Iscover (clopidogrel) has been shown to significantly reduce the rate of myocardial infarction, stroke and death by 20% in patients with unstable angina or non-Q-wave MI, collectively known as acute coronary syndrome, leading at least one investigator to the conclusion that the finding will result in a fundamental change in clinical practice.

The Clopidogrel in Unstable Angina to Prevent Recurrent Ischemic Events (CURE) study, presented at the American College of Cardiology meeting on March 20, looked at the effect of adding clopidogrel to standard therapy, including aspirin, in 12,562 patients from centers in 28 countries.

In the patients receiving aspirin-based standard therapy, the composite of death, MI and stroke occurred in 11.47%, compared to 9.28% of the clopidogrel group. Looking at individual endpoints, the rate of MI was reduced by 23% (6.68% versus 5.19%), while strokes were cut 15% (from 1.4% to 1.2%). Importantly, the benefits of clopidogrel were not accompanied by an increase in bleeding risk, with both aspirin and clopidogrel/aspirin groups having a 0.1% risk of hemorrhagic stroke.