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FDA Drug Safety Podcast for Healthcare Professsionals: Review update of Trilipix (fenofibric acid) and the ACCORD Lipid trial

Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today's topic: Review update of Trilipix (fenofibric acid) and the ACCORD Lipid trial.

Kim Wu, a pharmacist in the Division, will provide you with additional information about this Communication.

Guest Speaker: On November 9, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that the cholesterol-lowering medicine Trilipix, active ingredient 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, or the 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 the 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.

At this time, FDA recommends that Healthcare Professionals should be aware that:

  1. 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.
  2. They should consider the benefits and risks of Trilipix when deciding to prescribe the drug to patients, and counsel patients about those benefits and risks.
  3. They should encourage patients to read the Medication Guide they receive along with their Trilipix prescription.
  4. Adverse events involving Trilipix should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

Follow us on Twitter @FDA_Drug_Info for up to the minute important drug information. Know the moment it happens.



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