Harlan M. Krumholz, MD, SM reviewing Elam MB et al. JAMA Cardiol 2016 Dec 28.

Five years after the ACCORD study ended, fenofibrate in diabetes patients showed a significant hazard for women and no evidence of clinical effectiveness.

In the randomized, placebo-controlled Lipid Study of ACCORD (Action to Control Cardiovascular Risk in Diabetes), researchers found a lack of efficacy for what was then a blockbuster drug — fenofibrate — in patients with diabetes who were taking statins. Now, investigators have reported outcomes of the study participants 5 years after the study ended.

Findings from this passive follow-up study largely confirmed the original results. With a mean of 9.7 years of follow-up data, there was still no evidence of efficacy (although only 4% continued on fenofibrate after the study's end). In fact, the results appeared the same at the end of ACCORD and at this follow-up. There remained a concerning and highly significant association of fenofibrate with a hazard on the primary combined outcome of myocardial infarction and stroke in women (P=0.003). Fenofibrate also showed some improvement, with borderline significance, in patients with dyslipidemia (triglycerides, >204 mg/dL; HDL cholesterol, <34 mg/dL).

CITATION(S):

Elam MB et al. Association of fenofibrate therapy with long-term cardiovascular risk in statin-treated patients with type 2 diabetes. JAMA Cardiol 2016 Dec 28; [e-pub]. 

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