The ACCORD Lipid Study: Fenofibrate Doesn't Help in Diabetic Patients

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Summary and CommentThe ACCORD Lipid Study: Fenofibrate Doesn't HelpAlthough triglyceride levels improved markedly with fenofibrate, incidence of adverse cardiovascular events was not affected.Interventions that improve lipid profiles do not always improve patient outcomes. A common strategy in diabetic patients — who often have low HDL and elevated triglyceride levels — is to add fibrate therapy, despite mixed results in previous studies. In the government-funded ACCORD Lipid Study, researchers evaluated whether adding fenofibrate to statin therapy prevents adverse cardiovascular events in patients with type 2 diabetes.More than 5000 diabetic adults (mean age, 62; 31% women; glycosylated hemoglobin, 7.5%; LDL cholesterol, 60–180 mg/dL; HDL cholesterol, <55 mg/dL for women and blacks and <50 mg/dL for all others) were enrolled. All participants received simvastatin and also were assigned to daily fenofibrate (160 mg) or placebo. Mean follow-up was 4.7 years.In both groups, mean LDL levels dropped from 100 mg/dL to 80 mg/dL. Mean HDL levelsincreased from 38.0 mg/dL to 41.2 mg/dL in the fenofibrate group and to 40.5 mg/dL in the placebo group. Median triglyceride levels decreased from about 160 mg/dL to 122 mg/dL in the fenofibrate group and to 144 mg/dL in the placebo group. The primary endpoint, adverse cardiovascular events, occurred with similar frequency in the two groups (2.2% vs. 2.4% per year; hazard ratio, 0.92;P=0.32). No subgroup analysis was strongly positive, although women assigned to fenofibrate had higher adverse event rates than did women assigned to placebo. Fenofibrate recipients were significantly more likely than placebo recipients to leave the study (2.4% vs. 1.1%) because of a decrease in glomerular filtration rate.Comment: This important negative trial

indicates that fenofibrate should not be used for high-risk diabetic patients. Although it improved triglyceride profiles, no clinical benefit was seen. Moreover, worsening of renal function occurred more often with fenofibrate. The burden of proof is firmly on advocates of this drug to justify the cost and risk to patients.— Harlan M. Krumholz, MD, SMPublished in Journal Watch Cardiology March 14, 2010Citation(s):The ACCORD Study Group. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med2010 Mar 14; [e-pub ahead of print]. (http://dx.doi.org/10.1056/NEJMoa1001282) Regards, Vergelpowerusa dot org