Plavix (clopidogrel bisulfate) is now approved to reduce the rate of death from any cause and the rate of a combined endpoint of re-infarction, stroke or death in patients with acute ST-segment elevation myocardial infarction (STEMI).
STEMI is a severe acute heart attack in which a coronary artery is generally blocked completely. These blockages are caused by clot formation in the arteries, a life-threatening complication of an underlying disease known as atherothrombosis. However, this benefit is not known to pertain to patients who receive primary angioplasty.
According to data quoted by Sanofi-Aventis, approximately one-third of heart attacks in the US were STEMI events. Patients who have experienced STEMI are at high risk of another heart attack, stroke or death.
The new FDA approval was based on the results of two clinical trials of more than 48,000 patients in which STEMI patients treated with Plavix taken with aspirin and standard therapy were compared to STEMI patients treated with placebo taken with aspirin and standard therapy.
Results from the COMMIT/CCS-2 trial demonstrated that, in the 28 days following randomization, clopidogrel, taken with aspirin and standard therapy, reduced the relative risk of death in STEMI patients by 7%, and reduced the relative risk of the combination of myocardial infarction, stroke or death by 9%.
In the CLARITY – TIMI 28 trial, meanwhile, clopidogrel taken with aspirin and other standard therapy including thrombolytics significantly reduced the odds of STEMI patients having another occluded artery, or a second heart attack or death by 36% by day eight of hospitalization or discharge.
In terms of safety data, in both trials, the rates of major bleeding and intracranial hemorrhage were similar in both the Plavix groups and the placebo groups.
Data from these two trials have also been submitted to the European Medicines Evaluation Agency (EMEA) for a STEMI indication in the European Union, and recently received a positive opinion from the agency’s Committee for Medicinal Products for Human Use (CHMP).