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FDA Date: 11/9/11
Trilipix FDA Drug Safety Communication
FDA Drug Safety Communication for Trilipix
FDA is informing the public that the cholesterol-lowering medicine Trilipix (fenofibric acid) may not lower a patient's risk of having a heart attack or stroke. This is based on data from the Action to Control Cardiovascular Risk in Diabetes (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. FDA reviewed this trial as part of its ongoing investigation of the safety and efficacy of Trilipix.
Information from the trial has been added to the Important Limitations of Use and Warnings and Precautions sections of the Trilipix physician label and to the patient Medication Guide.
Healthcare professionals should consider the benefits and risks of Trilipix when deciding to prescribe the drug to patients. Patients should contact their healthcare professional if they have any questions or concerns about Trilipix.
In the ACCORD Lipid trial, there was no significant difference in the risk of experiencing a major adverse cardiac event between the group treated with fenofibrate plus simvastatin compared with simvastatin alone. 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. The clinical significance of this subgroup finding is unclear, as this finding was not observed in a separate large randomized controlled clinical trial of fenofibrate versus placebo.
Based on results from the ACCORD Lipid trial and other clinical trials of drugs similar to Trilipix, FDA is requiring the manufacturer of Trilipix to conduct a clinical trial to evaluate the cardiovascular effects of Trilipix in patients at high risk for cardiovascular disease who are already taking statins.
FDA had previously communicated to the public about the ACCORD Lipid trial in a Statement to Healthcare Professionals on March 15, 2010. The results of this trial were later discussed at the FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting, held on May 19, 2011.