BIP Trial
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BIP Trial On the Web |
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Click here to download slides for BIP Trial.
Objective
To determine the safety and efficacy of bezafibrate in raising HDL cholesterol and lowering triglycerides in patients with coronary artery disease.
Methods
This is a double-blinded study where 3090 patients with a previous myocardial infarction or stable angina with a total cholesterol of 180 - 250 mg/dL, HDL-C≤45 mg/dL, triglycerides≤300 mg/dL, and low-density lipoprotein cholesterol≤180 mg/dL were randomized to receive either 400 mg of bezafibrate per day or a placebo; they were followed for a mean of 6.2 years. fatal or nonfatal myocardial infarction or sudden death were the primary outcomes considered.
Results
- 18% increase in HDL-C and a 21% reduction observed in triglycerides.
- The reduction in the cumulative probability of the primary end point was 7.3% (P=0.24) after 6.2 years.
- Post hoc analysis in the group of patients with high baseline triglycerides (≥ 200 mg/dL) revealed a reduction by 39.5% (P=0.02) in the cumulative probability of the primary end point.
- Total and noncardiac mortality, adverse events and cancer were equally distributed between the two groups.
Conclusion
Bezafibrate was safe and effective in elevating HDL-C levels and lowering triglycerides. A reduction of the incidence of primary end points was also observed.[1]