FDA says it will review the ACCORD data 1

The FDA announced today that it will conduct a review of the ACCORD data. As reported here yesterday, ACCORD found that fenofibrate, when added to statins, failed to improve outcome in patients with type 2 diabetes.

The FDA said it “has made no new conclusions or recommendations regarding the combination use of simvastatin or other statin drugs and fenofibrate.” The FDA noted that the labeling for Trilipix “currently states that no incremental benefit of Trilipix on cardiovascular morbidity and mortality over and above that demonstrated for statin use alone had been established.”

Here is the FDA statement to healthcare professionals:

Statement to Healthcare Professionals on the ACCORD Lipid Trial from the FDA’s Center for Drug Evaluation and Research

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.

In 2008, FDA approved Trilipix (fenofibric acid):

“as an adjunct to diet in combination with a statin to reduce triglycerides (TG) and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal.”

The Trilipix labeling currently states that no incremental benefit of Trilipix on cardiovascular morbidity and mortality over and above that demonstrated for statin use alone had been established. Part of FDA’s review of the ACCORD trial will be to determine how the study’s findings relate to the approved indication and labeling for Trilipix.

Healthcare professionals should consider the available clinical information on simvastatin and fenofibrate when deciding what cholesterol-lowering medications to prescribe.

Patients should not stop taking their current medications without talking to their healthcare professional.

The agency will update the public with any new recommendations or conclusions when its review of the primary ACCORD trial data is complete.

One comment

  1. Pingback: FDA Reviewers Scrutinize ACCORD and Trilipix « CardioBrief

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