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Trilipix Efficacy in Question, Says FDA
New ACCORD Data Prompt Changes to Cholesterol Drug's Label
By News Staff
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.