U.S. health regulators on Wednesday said Abbott Laboratories' cholesterol drug Trilipix may not lower the risk of a heart attack or stroke.
The U.S. Food and Drug Administration reviewed data from a study, known as Accord-Lipid, that tested the efficacy and safety of a combination of fenofibrate and a cholesterol-lowering statin against the statin alone, in patients with type 2 diabetes.
Fenofibrate is similar to the active ingredient in Abbott's Trilipix.
There was no significant difference in the risk of experiencing a major adverse cardiac event between the two groups, FDA said on its website.
Based on results from Accord that was funded by the U.S. government and other trials of drugs similar to Trilipix, FDA said it requires Abbott to conduct a trial to test the cardiovascular effects of Trilipix in patients taking statins and at high risk for heart disease.
Trilipix belongs to a class of drugs known as fibrates that are designed to lower blood fats known as triglycerides and raise HDL or "good" cholesterol.
Combining Trilipix or other fibrates with statins has been a matter of much discussion. The Accord-Lipid study had found that combining a similar drug, TriCor, with a statin failed to reduce heart attacks and other cardiac problems.
[Updates: info on Humira, Tofacitinib, and VX-509 from ACR; FDA approves Xience Prime; PRGO submits Androgel ANDA; FDA requests phase-4 “outcomes” trial for TriLipix.]
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