Efficacy and safety of fenofibric acid in combination with atorvastatin and ezetimibe in patients with mixed dyslipidemia

Background: Statin and ezetimibe combination therapy may be insufficient to improve lipid and nonlipid parameters beyond low-density lipoprotein cholesterol (LDL-C) in patients with mixed dyslipidemia. Methods: In this phase 3, multicenter, double-blind study, a total of 543 patients with triglycerides >150 mg/dL and <400 mg/dL, high-density lipoprotein cholesterol (HDL-C) <40 mg/dL (<50 mg/dL for women), and LDL-C >130 mg/dL were randomized to 12 weeks of treatment with fenofibric acid 135 mg (FA) or placebo, each coadministered with atorvastatin 40 mg + ezetimibe 10 mg (Atorva/Eze). Results: Both treatment regimens lowered LDL-C by >50%; however, FA + Atorva/Eze resulted in significantly (P < .001) greater improvements in HDL-C (13.0% vs 4.2%), triglycerides (-57.3% vs -39.7%), non-HDL-C (-55.6% vs -51.0%), and apoprotein B (-49.1% vs -44.7%) compared with Atorva/Eze. Overall, adverse events were similar in the 2 treatment groups. No unexpected muscle, hepatic, or renal safety signals were identified with either treatment combination. Conclusions: In patients with mixed dyslipidemia, the combination of FA + Atorva/Eze significantly improved lipid and nonlipid parameters compared with Atorva/Eze and was generally well tolerated.