Home » Drug Information » FDA-Approved Drugs » 1997
Medical Areas: Cardiology/Vascular Diseases | Endocrinology
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Sanofi-aventis, Bristol-Myers Squibb
Approval Status: Approved November 1997
Treatment Area: atherosclerosis
PLAVIX (clopidogrel bisulfate) has been approved for the
reduction of atherosclerotic events (myocardial infaraction,
stroke, vascular deaths) in patients with atherosclerosis
documented by recent myocardial infarctions, recent stroke, or
established peripheral arterial disease.
The clearance to market PLAVIX was based primarily on the
results of the CAPRIE clinical trial, a randomized, double-blind
trial that enrolled 19,185 patients who had suffered a recent
ischemic stroke, recent heart attack, or had established peripheral
arterial disease.
CAPRIE compared the efficacy and safety of clopidogrel and
aspirin in reducing subsequent strokes, heart attacks, and other
vascular events in patients treated for a period of one to three
years.
PLAVIX is contraindicated in patients with active pathologic
bleeding or who have shown hypersensitivity to the drug or any
component of the drug and should be used with caution in patients
with severe liver disease. The most frequent side effects are rash,
diarrhea, and pruritis.
