Effects of Coadministered Ezetimibe Plus Fenofibrate in Mixed Dyslipidemic Patients with Metabolic Syndrome

OBJECTIVE: Patients with metabolic syndrome are at increased risk of atherosclerotic coronary heart disease, often have mixed dyslipidemia, and may thus require more aggressive treatment of multiple lipid parameters. The objective of this investigation was to compare the treatment response of ezetimibe co-administered with fenofibrate in mixed dyslipidemic patients with and without metabolic syndrome. METHODS: This post hoc analysis evaluated 625 patients 18-75 years of age with mixed dyslipidemia, defined as elevated low-density lipoprotein cholesterol (LDL-C) levels (130-220 mg/dL) and elevated triglycerides (TG) levels (200-500 mg/dL). Patients were randomized in a 1:3:3:3 ratio to 1 of 4 treatments for 12 weeks: Placebo; ezetimibe 10 mg; fenofibrate 160 mg; or ezetimibe 10 mg plus fenofibrate 160 mg. Metabolic syndrome was defined by the National Cholesterol Education Program Adult Treatment Panel III criteria and was identified at baseline in 450 patients. RESULTS: Ezetimibe alone, fenofibrate alone, or their combination produced expected, and generally similar, lipid effects among those with or without metabolic syndrome with respect to LDL-C, apolipoprotein B (ApoB), and non-high-density lipoprotein cholesterol (HDL-C) levels. Ezetimibe alone may have resulted in greater LDL-C and ApoB lowering in the metabolic syndrome group than the non-metabolic syndrome group (P ≤ 0.05 for both). TG and high-sensitivity C-reactive protein had greater reductions in the fenofibrate and fenofibrate plus ezetimibe groups than the ezetimibe alone group (P ≤ 0.05 for both) CONCLUSIONS: In this analysis of patients with mixed dyslipidemia, the lipid effects of ezetimibe plus fenofibrate were generally similar in metabolic syndrome patients versus those without metabolic syndrome.