Statins Plus Fibrates Show No Benefit

These US authors investigated whether combination therapy with a statin plus a fibrate, as compared with statin monotherapy, would reduce the risk of cardiovascular disease in patients with Type 2 diabetes mellitus who were at high risk for cardiovascular disease. They randomly assigned 5,518 patients with Type 2 diabetes who were being treated with open-label simvastatin to receive either masked fenofibrate or placebo. The primary outcome was the first occurrence of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The mean follow-up was 4.7 years.

They found, "The annual rate of the primary outcome was 2.2% in the fenofibrate group and 2.4% in the placebo group (hazard ratio in the fenofibrate group, 0.92, NS). There were also no significant differences between the two study groups with respect to any secondary outcome. Annual rates of death were 1.5% in the fenofibrate group and 1.6% in the placebo group. Prespecified subgroup analyses suggested heterogeneity in treatment effect according to sex, with a benefit for men and possible harm for women, and a possible interaction according to lipid subgroup, with a possible benefit for patients with both a high baseline triglyceride level and a low baseline level of high-density lipoprotein cholesterol."

The authors concluded, "The combination of fenofibrate and simvastatin did not reduce the rate of fatal cardiovascular events, nonfatal myocardial infarction, or nonfatal stroke, as compared with simvastatin alone. These results do not support the routine use of combination therapy with fenofibrate and simvastatin to reduce cardiovascular risk in the majority of high-risk patients with Type 2 diabetes."

N Engl J Med 362(17):1563-1574, 29 April 2010 © 2010 to the Massachusetts Medical Society
Effects of Combination Lipid Therapy in Type 2 Diabetes Mellitus-The ACCORD Study Group. Henry N. Ginsberg, Marshall B. Elam, Laura C. Lovato, et al.