Authors

  1. Aschenbrenner, Diane S. MS, APRN, BC

Article Content

According to these studies:

 

* The drug has been found to be effective in patients with myocardial infarction with acute ST-segment elevation.

 

 

The labeling of clopidogrel (Plavix), a drug that inhibits platelet aggregation, has been revised to include a new indication-the prevention of thrombotic events in patients who have had myocardial infarction with acute ST-segment elevation and who are not going to have coronary artery repair. Clopidogrel in these patients has been found to reduce both the mortality rate and the combined number of recurrent heart attacks, strokes, and deaths, compared with placebo, findings that likely result from improved coronary artery blood flow and the consequent prevention of the reocclusion of arteries. Revisions to the label were prompted by findings of the Clopidogrel and Metoprolol in Myocardial Infarction Trial, conducted in China among 46,000 patients, and of the Clopidogrel as Adjunctive Reperfusion Therapy study involving 3,500 patients.

 

Clopidogrel already has as labeled indications the reduction of atherosclerotic events in patients who recently suffered myocardial infarction or stroke or who have established peripheral artery disease, and use in patients with non-ST-segment elevation acute coronary syndrome who are either to be medically managed or to receive percutaneous coronary intervention (with or without stenting) or coronary artery bypass graft.

 

DA

 
 

Chen ZM, et al. Lancet 2005;366(9497):1607-21

 

Scirica BM, et al. J Am Coll Cardiol 2006;48(1):37-42

 

U.S. Food and Drug Administration. Center for Drug Evaluation and Research. Revised label for Plavix. 2006. http://www.fda.gov/cder/foi/label/2006/020839s034lbl.pdf

 

U.S. Food and Drug Administration. FDA approves new medical use for plavix: drug benefits patients with common form of heart attack. 2006. http://www.fda.gov/bbs/topics/NEWS/2006/NEW01431.html.