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The ACCORD trial was a 2 ×2 factorial trial that examined the effect of intensive blood pressure, blood sugar and lipid control on the rate of cardiovascular events among patients with type 2 diabetes mellitus:
The lipid control arm randomized 5,518 patients to fenofibrate or placebo in addition to baseline statin therapy
Fenofibrate was not associated with improvement in the risk of cardiovascular events when compared with placebo (Hazard Ratio [HR], 0.92; [95% CI: 0.79 to 1.08]; P=0.32)
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Two subgroup analyses are particularly notable:
The effect of fibrates was significantly different among men and women (P value for interaction 0.01), as fenofibrate lowered CV risk in men but elevated CV risk among women.
The effect of fibrates was nearly significantly different among patients with elevated triglyceride (≥204 mg/dL) and reduced high-density lipoprotein levels (≤34 mg/dL) (P value for interaction 0.06), as fenofibrate lowered CV risk among these patients but had no effect among all other patients.
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