Trilipix® (Fenofibric Acid)
November 10, 2011
FDA is alerting healthcare professionals and consumers that fenofibric acid (Trilipix®) and fenofibrate at a dose equivalent to Trilipix® 135 mg did not reduce the risk of heart attack or stroke in clinical trials. FDA reviewed the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial as part of an ongoing investigation on the efficacy and safety of Trilipix. The ACCORD trial evaluated the efficacy and safety of fenofibrate plus simvastatin (n=2765) compared to simvastatin alone (n=2753) in patients with type 2 diabetes. The trial found no significant difference between groups in the risk of cardiovascular events. There was a trend toward increased risk of major cardiovascular adverse events in women treated with fenofibrate plus simvastatin compared to women treated with simvastatin alone (hazard ratio 1.38; 95% CI 0.98 to 1.94). Fenofibrate at a dose equivalent to Trilipix 135 mg did not reduce cardiovascular morbidity and mortality in 2 large clinical trials in patients with type 2 diabetes.
Trilipix is labeled to reduce triglycerides and low-density lipoprotein (LDL) cholesterol and increase high-density lipoprotein (HDL) cholesterol in patients with various hyperlipidemias. The Trilipix product label has been updated to include information regarding the ACCORD trial results. FDA is requiring the manufacturer of Trilipix to conduct an additional clinical trial to evaluate the cardiovascular benefits of Trilipix in patients at high risk for cardiovascular disease with statin-controlled LDL cholesterol.
Do not stop Trilipix therapy without consulting a healthcare provider. Consider the risks and benefits of Trilipix and counsel patients on these prior to treatment with Trilipix.
Additional information is available at the following links:
- MedWatch Alert:
- Drug Safety Communication:
- Trilipix Package Insert (updated September 2011):
November 10, 2011. University of Utah Drug Information Service. Copyright 2011, Drug Information Service, Universtiy of Utah, Salt Lake City, Utah.