MEMPHIS—Cardiovascular risk is increased in patients with Type 2 diabetes, at least partly because of hypertriglyceridemia and low high-density lipoprotein cholesterol.
A study published online by JAMA Cardiology sought to determine if the risk is reduced by adding fenofibrate, which lowers triglycerides, to statin therapy.1
Researchers from the Memphis VAMC and the University of Tennessee Health Sciences Center, also in Memphis, and colleagues used a post-trial follow-up of the Action to Control Cardiovascular Risk in Diabetes Lipid Study to help answer the question. Results indicate that fenofibrate therapy was associated with reduced cardiovascular disease in study participants with dyslipidemia, defined as triglyceride levels greater than 204 mg/dL and high-density lipoprotein cholesterol levels less than 34 mg/dL.
The extended post-trial follow-up of the ACCORD Lipid Study participants was conducted between July 2009 and October 2014 and involved 4,644 participants who were selected based on the presence of Type 2 diabetes and either prevalent CVD or CVD risk factors and high-density lipoprotein levels less than 50 mg/dL (<55 mg/dL for women and African-American individuals).
In the passive follow-up of study participants previously treated with fenofibrate or masked placebo, researchers were looking for occurrence of cardiovascular outcomes, including primary composite outcome of fatal and nonfatal myocardial infarction and stroke in all participants and in pre-specified subgroups.
Researchers note that only 4.3% of study participants continued treatment with fenofibrate following completion of ACCORD and that high-density lipoprotein and triglyceride values rapidly equalized among participants originally randomized to fenofibrate or placebo.
Over a median total post-randomization follow-up of 9.7 years, the hazard ratio (HR) for the primary study outcome among participants originally randomized to fenofibrate vs placebo, 0.93, was comparable with that originally observed in ACCORD, 0.92.
“Despite these overall neutral results, we continued to find evidence that fenofibrate therapy effectively reduced CVD in study participants with dyslipidemia, defined as triglyceride levels greater than 204 mg/dL and high-density lipoprotein cholesterol levels less than 34 mg/dL (HR, 0.73; 95% CI, 0.56-0.95),” according to study authors.
- Elam MB, Ginsberg HN, Lovato LC, Corson M, et. al. ACCORDION Study Investigators. Association of Fenofibrate Therapy With Long-term Cardiovascular Risk in Statin-Treated Patients With Type 2 Diabetes. JAMA Cardiol. 2016 Dec 28. doi: 10.1001/jamacardio.2016.4828. [Epub ahead of print] PubMed PMID: 28030716.