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FDA to Review Adverse Events Seen With Trilipix Zocor Combination

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Washington, DCNew data from the ACCORD-Lipid trial has the Food and Drug Administration (FDA) concerned because they show that adding a fibrate drug to a statin increased the risk of cardiac events in women. The FDA plans to set up an advisory committee meeting in May to review the results.

The new analysis of the ACCORD-Lipid trial looked at the addition of delayed-release fenofibric acid (Trilipix) to simvastatin (Zocor) in diabetic patients. Although the FDA has said the significance of the findings is unclear, a subgroup analysis showed major adverse cardiac events occurred more frequently in women on combination therapy, compared with those taking just simvistatin.

The main finding from the trial was that combination therapy didn't reduce the incidence of cardiovascular events compared with patients taking statins alone.

The FDA reportedly plans to review the ACCORD-Lipid data with a specific focus on the approved labeling for Trilipix, which is currently approved for reducing triglyceride and cholesterol levels in patients with hyperlipidemia.

The FDA Endocrinologic and Metabolic Drugs Advisory Committee will meet May 19 to review the ACCORD results as they relate to the efficacy and safety of the delayed-release fenofibric acid.

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