The FDA said it was concerned about trial data suggesting that adding a fibrate drug to a statin increased the risk of cardiac events in women and will convene an advisory committee meeting next month to review the findings.
The agency was reacting to a new analysis of the ACCORD-Lipid trial, which tested the addition of delayed-release fenofibric acid (Trilipix) to simvastatin (Zocor) in diabetic patients.
Main results from the trial, announced in March 2010, indicated that the combination did not reduce cardiovascular events relative to patients receiving only the statin drug.
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