FDA Safety Communication on Fenofibrate

Health Care 154 Comments

The US FDA has issued a safety communication on cholesterol-lowering agent fenofibric acid, stating that the drug may not lower the risk of major cardiovascular events  based on ACCORD Lipid trial, in which the combination of fenofibrate plus simvastatin was compared with simvastatin alone in patients with type 2 diabetes mellitus.

There was no significant difference in the risk of experiencing a major adverse cardiac event between the fenofibrate/simvastatin group and the simvastatin-alone group in the trial.

A  subgroup analysis showed that relative to treatment in men, there was an increase in the risk for major adverse cardiac events in women receiving the combination therapy vs simvastatin alone.

FDA advisory panel meeting earlier this year also recommended that a new trial was needed of fenofibrate in diabetic patients who have met their LDL-cholesterol goal on a statin but still have high triglycerides and low HDL cholesterol.

Fenofibrate was approved in 2008 to be used with a statin to reduce triglycerides and increase HDL cholesterol in diabetic patients with mixed dyslipidemia and coronary disease.

At 5 years of follow-up in ACCORD, the composite of fatal cardiovascular events, nonfatal MI, and nonfatal stroke was around 11% in both patients randomized to simvastatin plus fenofibrate and patients randomized to simvastatin plus placebo.

However, there was a strong trend toward fewer cardiac events in patients with high triglycerides and low HDL cholesterol treated with fenofibrate.

(Source: Medscape, Medpage, FDA)