CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

November 9th, 2011

18 Months After ACCORD, FDA Says Fenofibrate May Not Lower Risk for MI or Stroke

Eighteen months after the ACCORD (Action to Control Cardiovascular Risk in Diabetes ) trial found no benefit for the addition of fenofibrate to simvastatin in patients with type 2 diabetes, the FDA has issued a safety communication. The agency changed the label for Trilipix (fenofibric acid, Abbott) and is notifying healthcare professionals that the drug “may not lower a patient’s risk of having a heart attack or stroke.” The information about ACCORD has been added to the Important Limitations of Use and Warnings and Precautions sections of the label, as well as the patient Medication Guide.

The FDA has also required Abbott to conduct a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that fenofibrate in combination with a statin versus statin alone significantly reduces cardiovascular events in high-risk men and women who are at their LDL cholesterol goal on statin therapy, but have residually high triglycerides and low HDL cholesterol.

Categories: General, Prevention


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