Trilipix Efficacy in Question, Says FDA

New ACCORD Data Prompt Changes to Cholesterol Drug's Label

November 16, 2011 06:10 pm News Staff

Fenofibric acid, an active form of fenofibrate that is marketed as Trilipix, may not reduce the risk of heart attack or stroke, according to a Nov. 9 FDA safety announcement( Family physicians may wish to notify their patients that although the drug has not been shown to lower these cardiovascular risks, patients should not stop taking the medication without first consulting their physician.

[FDA News]

The efficacy of the cholesterol-lowering medication is being called into question based on data from the recent Action to Control Cardiovascular Risk in Diabetes, or ACCORD, Lipid trial, which evaluated the efficacy and safety of fenofibrate plus simvastatin combination therapy versus simvastatin alone in patients with type 2 diabetes mellitus.

According to the FDA report, fenofibrate, at a dose equivalent to 135 mg of Trilipix, was not shown to reduce coronary heart disease morbidity and mortality in patients in two large randomized controlled trials. Based on that finding, the agency required that information from the ACCORD trial be added to the "Important Limitations of Use" and "Warnings and Precautions" sections of the Trilipix package label and to the patient medication guide that accompanies the drug.

In addition, 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 versus simvastatin alone. However, the clinical significance of this subgroup finding is unclear because this finding was not observed in a separate, large, randomized clinical trial involving fenofibrate versus placebo.

The FDA suggests that health care professionals

  • consider the benefits and risks of fenofibric acid when deciding whether to prescribe the drug to patients, and counsel patients about those benefits and risks,
  • encourage patients to read the medication guide they receive along with their fenofibric acid prescription, and
  • report adverse events involving fenofibric acid to the FDA's MedWatch program(

The FDA now is requiring the drug's manufacturer to conduct a clinical trial evaluating the cardiovascular effects of fenofibric acid in patients at high risk for cardiovascular disease who are already taking statins. Specifically, the trial is to assess whether the medication significantly reduces the incidence of major adverse cardiovascular events in high-risk men and women who are at their LDL cholesterol goal on statin therapy but have residually high triglycerides and low HDL cholesterol.