DRUG COMBO COULD HARM PATIENTS WITHOUT CLINICALLY EVIDENT CVD

Anna D. Garrett, PharmD, BCPS, CPP
Published Online: Thursday, June 1, 2006

A recent study of the safety and efficacy of clopidogrel (Plavix; 75 mg per day) plus aspirin (75-162 mg per day), compared with aspirin alone, resulted in findings that suggested no benefits and possible harm from the combination of the 2 drugs. The study included 15,603 patients with either clinically evident cardiovascular disease (CVD) or multiple risk factors for CVD. After a median of 28 months of follow-up, the primary efficacy end point—a composite of myocardial infarction (MI), stroke, or death from cardiovascular causes—occurred in patients with established CVD at rates of 6.8% in the clopidogrel group and 7.3% in the placebo group. In patients with risk factors but no evidence of CVD, events occurred at rates of 6.6% in the clopidogrel group versus 5.5% in the placebo group. Although this finding was not statistically significant, the rates of death between the 2 groups did reach statistically significant levels. Severe bleeding risks were elevated in the combination group (1.7% vs 1.3%), as were the risks of moderate bleeding (2.1% vs 1.3%).

The American Heart Association has issued a statement specifying those patients that may benefit from the use of clopidogrel. They include some patients who have had an MI; patients who have had angioplasty for unstable angina or heart attack; patients who have received either a bare-metal or drug-eluting stent; patients with peripheral artery disease; and patients who have had a transient ischemic attack or other stroke.

Dr. Garrett is a clinical pharmacist practitioner at Cornerstone Health Care in High Point, NC.




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