Trilipix Not Found to Reduce Risk of Coronary Events

FDA advises physicians to counsel patients on risks and benefits

WEDNESDAY, Nov. 9 (HealthDay News) -- Trilipix (fenofibric acid), a cholesterol-lowering medication, may not reduce the risk of heart attack or stroke, and physicians should consider the risks and benefits of the drug before prescribing it to patients, according to a safety communication issued Nov. 9 by the U.S. Food and Drug Administration.

The agency's update is due to the results of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial, which found no difference in the risk of heart attack or stroke between groups taking fenofibrate plus simvastatin or the statin alone.

The FDA advises patients taking Trilipix not to discontinue it before consulting with their provider to discuss the associated risks and benefits, and to read the medication guide they receive with a Trilipix prescription. Providers are advised to counsel patients on risks and benefits and to encourage them to read the medication guide.

According to the FDA, "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 of patients with type 2 diabetes mellitus; health care professionals should consider the benefits and risks of Trilipix when deciding to prescribe the drug to patients, and counsel patients about those benefits and risks."

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