FDA Approves Plavix for Acute MI

Today the FDA approved clopidogrel (Plavix) for acute myocardial infarction when the patient is NOT a candidate for revascularization with angioplasty (opening the artery directly) and instead receives the thrombolytic (clot-busting drug) therapy.

Two studies support the effectiveness of Plavix in treating STEMI heart attack patients. A large trial, the Clopidogrel and Metoprolol in Myocardial Infarction Trial (COMMIT) study, demonstrated that Plavix, when combined with other standard treatments including thrombolysis, a procedure to dissolve clots, reduced mortality and also reduced the combined number of recurrent heart attacks, strokes and deaths. COMMIT was a randomized, double-blind, placebo-controlled trial of 46,000 patients conducted in China.

The findings in COMMIT in China are supported by the results of the Clopidogrel as Adjunctive Reperfusion Therapy (CLARITY) study. CLARITY was a clinical trial of 3,500 patients undergoing thrombolysis for STEMI heart attacks. CLARITY showed that the coronary artery blood flow was better with clopidogrel treatment compared to placebo.

For folks without easy access to a heart catheterization laboratory during a heart attack, this might help their outcome.

Given the recent release of generic forms of clopidogrel, it might not help Bristol-Meyers Squibb(BMS)/Sanofi Aventis overcome its lost market share to cardiologists, though.

--Wes