FDA adds warning to Trilipix

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Abbott’s cholesterol drug fenofibrate (Trilipix) has made news again after the FDA put out a drug safety communication statement warning the public that the drug may not be all it's cracked up to be in terms of lowering a patient’s risk of MI or stroke. These data are based on the ACCORD Lipid trial, which evaluated the safety of fenofibrate plus simvastatin combination therapy versus simvastatin (Zocor, Merck Pharmaceuticals) alone in diabetic patients.

Back in May, members of the Endocrinologic and Metabolic Drug Advisory Committee  met to question the future of fenofibrate and evaluated whether the drug should still be allowed on the market. The 13 voting members voted unanimously in favor of the drug company conducting a trial to gain more evidence as to whether or not add-on fenofibrate reduced the risk of major adverse cardiovascular events (MACE) in high-risk patients with high triglycerides and low high-density lipoprotein cholesterol (HDL-C).

FDA has added the results to the "Limitations of Use and Warnings section" of fenofibric acid after it found that a 135 mg dose of Trilipix did not reduce coronary heart disease morbidity and mortality in patients in two clinical trials studying diabetics. During the ACCORD Lipid trial, results showed no significant difference in the risk of experiencing a major CV event between the group treated with fenofibrate and simvastatin compared with simvastatin alone. In a subgroup analysis, it was reported that there was an increase in the risk of MACE in women receiving the combination therapy versus simvastatin alone.  However, FDA said that, “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.“

FDA will now require Abbott to conduct a clinical trial that will evaluate the cardiovascular effects of fenofibric acid in patients at a high-risk for CV disease who are already administered statins. However, FDA said that patients should not cease taking Trilipix without first consulting a physician.

Trilipix was approved in 2008 as the first and only fibrate approved for use in combination with statin to lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems.