Cholesterol drug Trilipix, manufactured by Abbott Laboratories, may not lower the risk of heart attack or stroke, the FDA said Wednesday.
The agency came to the decision after reviewing data from a U.S. government-funded study known as Accord-Lipid, reports Reuters.
The study 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's properties are similar to the active ingredient found in Abbott's Trilipix.
The FDA said on its website that no significant difference was found between the two groups in the risk of experiencing a major adverse cardiac event.
The Accord-Lipid study found that combining a similar drug, TriCor, with a statin failed to reduce heart attacks and other cardiac problems, Reuters reports.
Based on Accord’s results and other trials’ findings concerning drugs similar to Trilipix, FDA said it requires Abbott to conduct a trial to test Trilipix’s cardiovascular effects 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.
Abbott’s shares dipped 1 percent to $53.70 in morning trade on the New York Stock Exchange, reports Reuters.
