FDA changes label for Trilipix

November 28, 2011

FDA has changed the label for fenofibric acid (Trilipix, Abbott). It now carries a warning that the agent may not lower the risk of myocardial infarction or stroke.

The label for fenofibric acid (Trilipix, Abbott) now carries a warning that the agent may not lower the risk of myocardial infarction or stroke. FDA added the new information after reviewing the results of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid Trial.

In the ACCORD trial, there was no statistically significant difference in the risk of experiencing a major cardiac event between the group treated with fenofibrate plus simvastatin (Zocor, Merck) compared to simvastatin alone, said FDA pharmacist Kim Wu, PharmD, during a podcast in early November. FDA reviewed the trial as part of its ongoing investigation into the safety and efficacy of Trilipix.

Information from ACCORD was added to the Important Limitations of Use and the Warnings and Precautions sections of the package insert and the patient Medication Guide. Fenofibrate at a dose equivalent to 135 mg of Trilipix was not shown to reduce morbidity or mortality from coronary heart disease (CHD) in patients with type 2 diabetes. Similar results were seen in the Fenofibrate Intervention and Event Lower in Diabetes (or FIELD) trial.

Trilipix was approved in 2008 for use with a statin to reduce triglycerides and boost HDL cholesterol in patients with diabetes who also had mixed dyslipidemia and CHD or who were at risk for CHD and were already on optimal statin therapy to meet their LDL cholesterol goal.

FDA also directed the manufacturer to conduct a clinical trial to evaluate the cardiovascular outcomes of Trilipix in patients at high risk for cardiovascular disease who are already taking statins. Prior trials have been based on surrogate end points.