Using Fibrates to Lower Diabetic Patients' Cardiac Risks

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Using Fibrates to Lower Diabetic Patients' Cardiac Risks
This viewpoint offers commentary on important clinical research in the area of pharmacy.

Effects of Long-term Fenofibrate Therapy on Cardiovascular Events in 9795 People With Type 2 Diabetes Mellitus (the FIELD Study): Randomised Controlled Trial


Kumar A, Soares H, Wells R, et al
BMJ. 2005;331(7528):1295

Keech A, Simes RJ, Barter P, et al
Lancet. 2005;366(9500):1849-1861

Study Summary


Patients with diabetes have lipid patterns that differ from those of the general population. These patterns can be corrected with fibrates. Treatment with fibrates generally increases high-density lipoprotein (HDL) cholesterol concentrations and lowers triglycerides while decreasing total cholesterol. This study was initiated to provide an assessment of the effects of fenofibrate treatment on coronary morbidity and mortality in patients with type 2 diabetes.

The 9795 patients were randomized to treatment with either fenofibrate or placebo and were not taking statins at study entry. Once the treatment had begun, the physician was allowed to add additional lipid-lowering therapy if needed. During the 5 years of the study duration, more patients receiving placebo than fenofibrate required additional lipid-lowering therapy (17% vs 8%). Patients receiving fenofibrate had a relative reduction of 11% in the occurrence of a coronary event (P = NS) and a 24% relative reduction in the incidence of a nonfatal myocardial infarction (P = .01).

Viewpoint


Despite the scientific rigor of the paper, the findings here are mixed. Total mortality was lower in the placebo group (P = NS), and fenofibrate did not significantly reduce the risk of coronary events (primary outcome). These results may be due to the increased use of additional lipid-lowering therapy in the placebo group. However, fibrates were well tolerated, and they did reduce nonfatal myocardial infarctions. Future research may better clarify the role of these agents in combination treatment with statins.

Abstract

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