Safety Alerts & Recalls
What does this mean?
It is important to avoid drawing too many conclusions from the results ACCORD study until the full study results are reviewed. The FDA will update the public with any new recommendations or conclusions when its review of the ACCORD study results is complete. In the meantime, you should continue taking your current cholesterol lowering medications. If you have any concerns about the ACCORD study results, please speak with your doctor or other healthcare professional.
FDA Makes Statement on the ACCORD Lipid Trial
The U.S. Food and Drug Administration (FDA) announced that it will review the primary results from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid Trial. The ACCORD Lipid Trial evaluated the potential heart related benefits in patients with type 2 diabetes mellitus taking simvastatin plus fenofibrate.
The ACCORD Lipid Trial looked at how often major heart disease related events (heart attack, stroke, heart disease related death) occurred in patients receiving simvastatin plus fenofibrate, compared to simvastatin alone. All patients in the study had a history of type 2 diabetes mellitus, were at high risk for heart disease, and were followed almost 5 years on average. The trial found that there was no difference in the heart disease related outcomes between the two groups.
At this time the FDA has made no new conclusions or recommendations regarding the combination use of simvastatin or other statin drugs and fenofibrate. The FDA will conduct a full review of the ACCORD study results as soon as they become available. Part of the FDA's review of the ACCORD trial will be to determine how the study's findings relate to the approved indication and labeling for Trilipix (choline fenofibrate). Trilipix is the only fenofibrate product approved to be used in combination with a statin in addition to diet to reduce triglycerides and increase HDL cholesterol.
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