The FDA ( Food and Drug Administration ) has approved the use of Plavix ( Clopidogrel ) for treatment of acute ST-segment elevation myocardial infarction ( STEMI ), in patients who are not going to have angioplasty.

FDA approved Plavix in November 1997 to decrease platelet function in people who suffer from acute coronary syndrome ( ACS ).

Two studies have shown the effectiveness of Plavix in treating STEMI myocardial infarction 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, reduces mortality and also reduces the combined number of recurrent myocardial infarction, 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 myocardial infarction. CLARITY showed that the coronary artery blood flow was better with Clopidogrel treatment compared to placebo.

Serious side effects of Plavix include bleeding and, rarely, low white blood cell counts or thrombotic thrombocytopenic purpura.

According to the American Heart Association ( AHA ), each year an estimated 500,000 Americans have a STEMI myocardial infarction.

Source: FDA, 2006


XagenaMedicine2006