http://www.theheart.org/article/130...il&utm_source=20111109_Breakingnews_Nov9_2011
The US FDA has issued a safety communication and updated the prescribing information for the cholesterol-lowering agent fenofibric acid (Trilipix, Abbott), stating that the drug may not lower the risk of major cardiovascular events [1]. 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.
The FDA has reviewed this trial as part of its ongoing investigation of the safety and efficacy of fenofibric acid. The agency notes that its review found that there was no significant difference in the risk of experiencing a major adverse cardiac event between the fenofibrate/simvastatin group and the simvastatin-alone group in the trial. In addition, a subgroup analysis showed that relative to treatment in men, there was an increase in the risk for major adverse cardiac events in women receiving the combination therapy vs simvastatin alone. But it adds that the clinical significance of this subgroup finding is unclear.
Based on these results and other clinical trials of similar drugs, the FDA says it 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.
These results from the trial have been added to the product label and to the patient medication guide. The agency says: "Healthcare professionals should consider the benefits and risks of Trilipix when deciding to prescribe the drug."
rest of article at link
The US FDA has issued a safety communication and updated the prescribing information for the cholesterol-lowering agent fenofibric acid (Trilipix, Abbott), stating that the drug may not lower the risk of major cardiovascular events [1]. 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.
The FDA has reviewed this trial as part of its ongoing investigation of the safety and efficacy of fenofibric acid. The agency notes that its review found that there was no significant difference in the risk of experiencing a major adverse cardiac event between the fenofibrate/simvastatin group and the simvastatin-alone group in the trial. In addition, a subgroup analysis showed that relative to treatment in men, there was an increase in the risk for major adverse cardiac events in women receiving the combination therapy vs simvastatin alone. But it adds that the clinical significance of this subgroup finding is unclear.
Based on these results and other clinical trials of similar drugs, the FDA says it 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.
These results from the trial have been added to the product label and to the patient medication guide. The agency says: "Healthcare professionals should consider the benefits and risks of Trilipix when deciding to prescribe the drug."
rest of article at link
