New use for Plavix

FDA Consumer, Nov-Dec, 2006

The FDA has approved the use of Plavix (clopidogrel) for people who have had a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI), and who are not going to have coronary artery repair (angioplasty).

A STEMI is a severe heart attack caused by the sudden, total blockage of an artery. Each year, an estimated 500,000 Americans have a STEMI heart attack, according to the American Heart Association. In STEMI patients, Plavix prevents subsequent blockage in the already-damaged heart vessel, which could lead to more heart attacks, stroke, and possibly death.

The FDA approved Plavix in November 1997 to decrease platelet function in people who suffer from acute coronary syndrome. Platelets are sticky blood cells that help form a clot, and can contribute to blocked coronary arteries.

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 are supported by 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 with placebo.

Serious side effects of Plavix include bleeding and, rarely, low white blood cell counts or low platelet counts with spontaneous bleeding and clotting (thrombotic thrombocytopenic purpura).

Plavix is manufactured by Sanofi Aventis of Bridgewater, N.J.