The following information is obtained from various newswires,
published medical journal articles, and medical conference presentations.
Company: Sanofi-Synthelabo
Approval Status: Approved February 2002
Treatment for: Acute coronary syndrome
General Information
Plavix has been approved by the FDA for the treatment of acute coronary syndrome (ACS), which is defined as unstable angina and non-Q-wave myocardial infarction (mild heart attack). Plavix works by preventing platelets from sticking together to form clots that would restrict blood flow.
Plavix was first approved for use in the United States in 1997. In addition to the new ACS indication, Plavix is currently used for the reduction of atherosclerotic events (myocardial infarction, stroke, and vascular death) in patients with atherosclerosis documented by recent stroke, recent myocardial infarction, or established peripheral arterial disease.
Clinical Results
The new indication of ACS was supported by positive results from the CURE (Clopidogrel in Unstable Angina to Prevent Recurrent Events) trial. The trial, which included 12,562 ACS subjects, compared Plavix to placebo, with both groups receiving standard therapy including aspirin. Results of the trial demonstrated that treatment with Plavix reduced the risk of heart attack, stroke or cardiovascular death by 20% in subjects with mild heart attack or unstable angina.
Side Effects
Plavix should not be used by individuals with active pathologic bleeding, such as peptic ulcer or intracranial hemorrhage.
Side effects reported in clinical trials include (but are not limited to) the following:
- Pruritus (localized or generalized itching)
- Purpura (purple discoloring of the skin)
- Diarrhea
- Rash
- Severe neutropenia (decrease in white blood cells)
Mechanism of Action
Clopidogrel is an inhibitor of platelet aggregation. A variety of drugs that inhibit platelet function have been shown to decrease morbid events in people with established atherosclerotic cardiovascular disease as evidenced by stroke or transient ischemic attacks, myocardial infarction, or need for bypass or angioplasty. This indicates that platelets participate in the initiation and/or evolution of these events and that inhibiting them can reduce the event rate. (from Plavix Prescribing Information)
Additional Information
Clopidogrel is marketed by Sanofi-Synthelabo and Bristol-Myers Squibb under the trade names Plavix and Iscover.
For additional information on Plavix, please visit the product web site at www.plavix.com.
