Fenofibric acid does not reduce cardiac risk
FDA: Fenofibric acid does not reduce cardiac risk
Literature - FDA, November 9, 2011The FDA ordered on Wednesday that the label for fenofibric acid should be changed to indicate that the lipid-lowering drug has not been shown to reduce the risk of heart attack or stroke.
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 ACCORD data covered about 5,500 patients randomized to the combination or to simvastatin alone. After a median of 4.7 years of follow-up, the addition of fenofibric acid reduced major cardiovascular events by a statistically insignificant 8% (P=0.32). 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, although 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.
In Europe there seems to be a slightly more favorable view of the ACCORD Lipid results. An expert consensus panel from the European Atherosclerosis Society (EAS) recently recommended fibrates as one option for patients with elevated triglycerides and low HDL-cholesterol levels, although it acknowledged that the data were mixed and somewhat controversial.
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 ACCORD data covered about 5,500 patients randomized to the combination or to simvastatin alone. After a median of 4.7 years of follow-up, the addition of fenofibric acid reduced major cardiovascular events by a statistically insignificant 8% (P=0.32). 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, although 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.
In Europe there seems to be a slightly more favorable view of the ACCORD Lipid results. An expert consensus panel from the European Atherosclerosis Society (EAS) recently recommended fibrates as one option for patients with elevated triglycerides and low HDL-cholesterol levels, although it acknowledged that the data were mixed and somewhat controversial.
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