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Fenofibric acid may not lower risk for MI, stroke
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The FDA announced in a press release today that fenofibric acid may not lower MI or stroke risk, and that the warning label of the drug has been amended accordingly.
The announcement came in the wake of results of the ACCORD Lipid trial, which compared the efficacy and safety of combination fenofibrate/simvastatin therapy with simvastatin (Zocor, Merck) alone in patients with type 2 diabetes. The FDA has been conducting an ongoing investigation of the safety and efficacy of fenofibric acid (Trilipix, Abbott).
The administration is requiring the company to conduct a clinical trial to evaluate the CV effects of the drug in patients at high risk for CVD who are already taking statins.
The Important Limitations of Use and Warnings and Precautions sections of the physician label now include information from ACCORD, as does the patient Medication Guide.
No significant differences in risk for experiencing major adverse CV events were observed between the combination therapy and monotherapy groups. Results of a subgroup analysis indicated that relative to treatment in men, the risk for major adverse CV events was increased in women receiving combination therapy compared with those women receiving only simvastatin.
“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 vs. placebo,” FDA officials wrote in the press release.
Health care professionals are urged to consider the risks and benefits of fenofibric acid, and patients should contact their provider if questions or concerns about the drug.
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