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The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that it will review the primary data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid Trial, which evaluated the potential cardiovascular benefits in patients with type 2 diabetes mellitus taking simvastatin plus fenofibrate.
Presented at the American College of Cardiology conference on March 14, 2010, the ACCORD Lipid Trial, funded by the National Institutes of Health (NIH), evaluated the occurrence of major cardiovascular events (nonfatal heart attack, nonfatal stroke, cardiovascular death) in patients receiving simvastatin plus fenofibrate, compared to simvastatin alone. All patients in the study had a history of type 2 diabetes mellitus, were at high risk for cardiovascular disease, and were followed on average for 4.7 years. The trial found that there was no difference in cardiovascular outcomes between the two groups (Hazard Ratio = 0.92; 95% Confidence Interval: 0.79 – 1.08; p = 0.32).
At this time, FDA has made no new conclusions or recommendations regarding the combination use of simvastatin or other statin drugs and fenofibrate. The agency will conduct a thorough review of the primary ACCORD data as soon as they become available.
For more information please visit: ACCORD
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