MedPage Today (11/10, Gever) reports, "The FDA ordered on Wednesday that the label for fenofibric acid [Trilipix] be changed to indicate that the lipid-lowering drug has not been shown to reduce the risk of heart attack or stroke."
HeartWire (11/10, Hughes) reports, "This is based on data from the ACCORD Lipid trial, in which the combination of fenofibrate plus simvastatin was compared with simvastatin alone in patients with type 2 diabetes mellitus." Based on these findings, the FDA "has requested Abbott to conduct a clinical trial to evaluate the cardiovascular effects of fenofibric acid in patients at high risk for cardiovascular disease who are already taking statins." Also covering the story are Forbes (11/10, Husten,) and Reuters
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