sanofi-aventis and Bristol-Myers Squibb Company announced that the European Commission has granted a new indication for the antiplatelet agent Plavix (clopidogrel bisulfate) to include patients with ST-segment Elevation acute Myocardial Infarction (STEMI) who are eligible for thrombolytic therapy.
STEMI is a severe heart attack in which an artery supplying the heart with blood is generally blocked completely. These blockages are caused by clot formation in the coronary arteries, which is associated with an underlying disease known as atherothrombosis, a company press release stated.
Plavix is a prescription antiplatelet medicine taken once a day that helps keep platelets in the blood from sticking together and forming clots. Plavix is approved for early and long term risk reduction in patients at risk for atherothrombotic events. The new indication is based on the findings of two clinical trials that treated patients who had STEMI with Plavix administered on a background of standard therapy, including ASA.
"Plavix taken with ASA has previously been shown to reduce the risk of death, recurrent heart attacks or stroke in patients with unstable angina or less severe heart attacks," said Keith A.A. Fox, Professor of Cardiology, University of Edinburgh, Scotland. "Now, based on the results of two clinical trials, CLARITY-TIMI 28 and COMMIT/CCS-2, clopidogrel has been approved by the European Commission as showing benefit, together with ASA (acetyl salicylic acid), in patients with the most severe types of heart attacks. With this new guidance from the European Commission, clopidogrel shows benefit in patients across the spectrum of acute coronary syndrome."
There are approximately 10 million heart attacks per year worldwide; and 3 million are STEMI events. In 2005, for the United Kingdom, France, Germany, Italy and Spain, there were more than 1 million acute coronary syndrome events, of which 25% were STEMI. Patients who have experienced STEMI are also at high risk of another heart attack, stroke or death.
The European Commission approval was based on the results of two clinical trials in which STEMI patients were treated with Plavix taken with ASA and standard therapy. In the CLARITY - TIMI 28 (CLopidogrel as Adjunctive ReperfusIon TherapY - Thrombolysis In Myocardial Infarction Study 28) trial, patients were followed for 30 days.In the COMMIT/CCS-2 (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) trial, patients were followed for 28 days.
In the CLARITY - TIMI 28 trial, clopidogrel taken with ASA and other standard therapy including fibrinolytics (clot-dissolving medicines) reduced the odds of STEMI patients having another occluded artery, or a second heart attack or death by 36 percent by day eight of hospitalization or hospital discharge (event rate: 15.0% in clopidogrel arm vs. 21.7% in placebo; P<0.001). Results of the COMMIT/CCS-2 trial demonstrated that in the 28 days following randomization, clopidogrel, taken with ASA and standard therapy, reduced the relative risk of death in STEMI patients by 7 percent (event rate: 7.5% vs. 8.1%; P=0.03), and reduced the relative risk of MI, stroke or death by 9 percent (event rate: 9.2% vs. 10.1%; P=0.02).
"Survivors of STEMI events are at high risk of suffering another event," said Professor Fox. "The results of the CLARITY-TIMI 28 and COMMIT trials represent a major advance for patients who have had a severe heart attack, and this indication for clopidogrel provides clinicians with a new option for treating STEMI patients in order to reduce their risk of heart attack, stroke or death."
In both trials, the rates of major bleeding and intracranial hemorrhage were similar in both the Plavix groups and the placebo groups.
Plavix received approval for the STEMI indication by the US Food and Drug Administration on August 17, 2006.
The new STEMI indication reinforces the strong commitment of two research and development pharmaceutical companies dedicated to improving patient health.