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. Author manuscript; available in PMC: 2015 Jul 1.
Published in final edited form as: JAMA Intern Med. 2014 Jul 1;174(7):1176–1182. doi: 10.1001/jamainternmed.2014.1371
  • 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:

    • All subjects participated in the blood sugar trial

    • Subjects were then randomized to either the blood pressure or lipid control arm

  • 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)

  • 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.