Efficacy and safety of fenofibric acid in combination with a statin in patients with mixed dyslipidemia: Pooled analysis of three phase 3, 12-week randomized, controlled studies

BACKGROUND: Patients with mixed dyslipidemia often require combination therapy to manage multiple lipid abnormalities. OBJECTIVE: To evaluate fenofibric acid in combination with a statin across three Studies of patients with mixed dyslipidemia. METHODS: As prospectively planned, data were pooled from three randomized. double-blind. phase 3 studies of patients with low-density lipoprotein cholesterol (LDL-C) >= 130 mg/dL, triglycerides (TG) >= 150 mg/dL, and high-density lipoprotein cholesterol (HDL-C) < 40 mg/dL (men) or < 50 mg/dL (women). A total of 2715 patients were randomly assigned to 12-week treatment with fenofibric acid 135 mg monotherapy low-, moderate-, or high-dose statin (rosuvastatin, simvastatin, or atorvastatin, depending on study) monotherapy or fenofibric acid + low- or moderate-dose statin. The primary efficacy comparisons were mean percent change in HDL-C and TG (combination therapy vs. statin) and LDL-C (combination therapy vs. fenofibric acid). RESULTS: Fenofibric acid + low-close statin increased HDL-C (18.1% vs. 7.4%) and reduced TG (-43.9% vs. -16.9%) versus low-dose statin monotherapy and reduced LDL-C (-33.1% vs. -5.1%) versus fenofibric acid monotherapy (P <.001 for all). Fenofibric acid + moderate-close statin increased HDL-C (117.5% vs. 8.7%) and reduced TG (-42.0% vs. -23.7%) versus moderate-dose statin monotherapy and reduced LDL-C (-34.6% vs. -5.1%) versus fenofibric acid monotherapy (P <.001 for all). Combination therapy was generally well tolerated, and safety profiles were similar to monotherapies. No rhabdomyolysis was reported. CONCLUSION: In patients with mixed dyslipidemia, combination therapy simultaneously improved multiple lipid abnormalities more effectively than fenofibric acid or statin monotherapies. (c) 2009 National Lipid Association. All rights reserved.