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The ACCORD Lipid Study: Fenofibrate Doesn't Help

Although 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 levels increased 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, SM

Published in Journal Watch Cardiology March 14, 2010

Citation(s):

The ACCORD Study Group. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010 Mar 14; [e-pub ahead of print]. (http://dx.doi.org/10.1056/NEJMoa1001282)

Reader Remarks:

Review and add to remarks on this article

• Fenofibrate in Accord Study
  Brunel Bredy, MD, Soledad, CA, 15 Mar 2010 2:20 PM EST
  Does this study look at those diabetics who have higher triglyceride levels, and the benefit of fenofibrate use in these... [more]
• ACCORD lipid trial
  Lisa W Martin, 15 Mar 2010 2:20 PM EST
  The enrollment criteria in this study is very important. The subgroup analysis showed benefit for those patients with the dyslipidemia... [more]
• ACCORD Lipids
  Eliot Brinton, University of Utah, 16 Mar 2010 8:24 AM EST
  Despite Professor Krumholz’s statement to the contrary, it is not “a common strategy in diabetic patients… to add fibrate therapy”... [more]
• Accord lipid trial
  Alfonso E. Sierra, Private practice Newport RI, 18 Mar 2010 4:18 PM EST
  How important was the decrease in the GFR? 1?, 5? 10?, 20?, was it consistent?
• Response from the summary author
  Harlan Krumholz, Editor-in-Chief, Journal Watch Cardiology, 23 Mar 2010 11:53 AM EST
  Great discussion. What I can say is that someone is using fenofibrate since sales in the US are $1.3 billion... [more]

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