FDA warns fenofibric acid may not lower heart attack, stroke risk
MedWire News: The US Food and Drug Administration (FDA) has announced that the cholesterol-lowering agent fenofibric acid may not lower a patient's risk for experiencing a heart attack or stroke.
The safety communication comes following the FDA's review of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial, which evaluated the efficacy and safety of fenofibrate plus simvastatin combination therapy versus simvastatin alone in patients with Type 2 diabetes.
As reported previously by MedWire News, ACCORD randomly allocated patients to receive treatment with simvastatin plus fenofibrate (n=2765) or simvastatin plus placebo (n=2753).
Over a mean follow-up period of 4.7 years, fenofibrate plus simvastatin combination therapy reduced the relative risk for major adverse cardiovascular events (MACE; composite of myocardial infarction, nonfatal stroke, and cardiac mortality) by a nonsignificant 8%, compared with simvastatin plus placebo.
Subgroup analysis revealed that men receiving combination therapy were 18% less likely to experience MACE than those receiving simvastatin monotherapy. In contrast, women receiving combination therapy were 38% more likely to experience MACE than those receiving simvastatin monotherapy.
The authors of the study pointed out that the clinical significance of this subgroup finding was unclear, as it was not observed in a separate large randomized controlled clinical trial of fenofibrate versus placebo.
The results from the trial were discussed at the FDA Endocrinologic and Metabolic Drugs Advisory Meeting in May of this year.
As a result, information from the trial was added to the physician label and patient medication guide for fenofibric acid, which is currently marketed in the USA as Trilipix.
Healthcare professionals should consider the benefits and risks of fenofibric acid in prescribing decisions and counsel patients accordingly, the FDA said.
They should also report adverse events involving the drug to the FDA MedWatch program, the agency added.
Based on the results of the ACCORD trial, the FDA has stated that the manufacturer of Trilipix must conduct a randomized double-blind trial to test whether fenofibric acid in combination with a statin versus a statin alone significantly reduces the incidence of cardiovascular events.
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By Piriya Mahendra