A study published in JAMA Cardiology suggests that fenofibrate therapy may reduce cardiovascular disease (CVD) in patients with diabetes with hypertriglyceridemia and low high-density lipoprotein (HDL) cholesterol.
Individuals with type 2 diabetes have a high risk of CVD partly due to high triglyceride levels and low HDL levels. “It is unknown whether adding triglyceride-lowering treatment to statin reduces this risk,” explained study author Marshall B. Elam, PhD, MD, from the Memphis Veterans Affairs Medical Center and University of Tennessee Health Sciences Center, Memphis, TN. To assess whether fenofibrate reduces CVD risk in statin-treated patients with type 2 diabetes, study authors extended the post-trial follow-up of the ACCORD (Action to Control Cardiovascular Risk in Diabetes) Lipid Study patients between July 2009 and October 2014.
The 5-year extended follow-up included 4,644 surviving ACCORD Lipid Trial patients of the original 5,518; patients were selected based on the presence of type 2 diabetes and either prevalent CVD or CVD risk factors and HDL <50mg/dL (<55mg/dL for women and African-Americans). The main study outcome was occurrence of cardiovascular outcomes including primary composite outcome of fatal and nonfatal myocardial infarction and stroke in all participants and in prespecified subgroups.
The data showed HDL and triglyceride levels quickly normalized among patients that were initially randomized to fenofibrate or placebo.Over a median 9.7 follow-up years post-randomization, the hazard ratio (HR) for the primary outcome among patients originally randomized to fenofibrate vs. placebo (HR 0.93, 95% CI: 0.83–1.05; P=0.25) was similar to that originally seen in the ACCORD Lipid Trial (HR 0.92, 95% CI: 0.79–1.08; P=0.32).
“Despite these overall neutral results, we continued to find evidence that fenofibrate therapy effectively reduced CVD in study participants with dyslipidemia,” noted Dr. Elam. Dyslipidemia was defined as patients having triglycerides >204mg/dL and HDL <34mg/dL (HR 0.73, 95% CI: 0.56–0.95).
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