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No Added Benefit of Fenofibrate for Cardiovascular Risk in Diabetes Mellitus
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Am Fam Physician. 2011 Mar 1;83(5):612.
Background: Statins reduce the increased cardiovascular risk seen in patients with type 2 diabetes mellitus, but do not eliminate it. Studies have shown conflicting results as to whether fibrates may also help reduce cardiovascular disease in this population. Ginsberg and colleagues used the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial to determine if combination lipid therapy could reduce cardiovascular risk in patients with type 2 diabetes.
The Study: A total of 5,518 patients with type 2 diabetes were randomized to receive simvastatin (Zocor) at 40 mg per day or less, in addition to fenofibrate (Tricor; initial dosage of 160 mg per day) or placebo. All patients had an A1C level of 7.5 percent or more, a low-density lipoprotein cholesterol level of 60 to 180 mg per dL (1.55 to 4.66 mmol per L), a high-density lipoprotein (HDL) cholesterol level of less than 55 mg per dL (1.42 mmol per L), and a triglyceride level of less than 750 mg per dL (8.47 mmol per L). The mean follow-up period was 4.7 years. The primary outcome was a composite of the first occurrence of a major fatal or nonfatal cardiovascular event (i.e., myocardial infarction or stroke). Baseline characteristics were similar between groups: 37 percent had experienced a previous cardiovascular event and 60 percent were taking a statin before enrollment.
Results: No difference was noted between groups with regard to the composite cardiovascular outcome (2.2 versus 2.4 percent annual incidence for the fibrate and placebo groups, respectively). However, analysis based on sex showed that fibrates might have a benefit in men (11.2 versus 13.3 percent incidence of the primary outcome in the fibrate versus placebo group during the entire study; P = .01), whereas the reverse occurred in women (9.1 versus 6.6 percent, respectively; P = .01). A nonsignificant trend toward benefit occurred overall in patients with a triglyceride level of 204 mg per dL (2.31 mmol per L) or more and an HDL level of 34 mg per dL (0.88 mmol per L) or less. No differences were noted in most secondary outcomes (i.e., congestive heart failure, all-cause mortality, or separate analyses of myocardial infarction or stroke).
Conclusion: The authors conclude that, compared with simvastatin monotherapy, adding fenofibrate does not reduce the risk of cardiovascular events in patients with type 2 diabetes. This combination is not supported to prevent cardiovascular risk in most patients with type 2 diabetes; however, a small potential benefit occurred in men using both agents.
The ACCORD Study Group, Ginsberg HN, et al. Effects of combination lipid therapy in type 2 diabetes mellitus [published correction appears in N Engl J Med. 2010;362(18):1748]. N Engl J Med. April 29, 2010;362(17):1563–1574.
Copyright © 2011 by the American Academy of Family Physicians.
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