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.

Abstract

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) ≥130mg/dL, triglycerides (TG) ≥150mg/dL, and high-density lipoprotein cholesterol (HDL-C) <40mg/dL (men) or <50mg/dL (women). A total of 2715 patients were randomly assigned to 12-week treatment with fenofibric acid 135mg 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-dose statin increased HDL-C (18.1% vs. 7.4%) and reduced TG (-43.9% vs. -16.8%) 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-dose statin increased HDL-C (17.5% 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.

• Authors: Peter H Jones, Michael H Davidson, Anne C Goldberg, Carl J Pepine, Maureen T Kelly, Susan M Buttler, Carolyn M Setze, Aditya Lele, Darryl J Sleep, James C Stolzenbach
• Journal: Journal of clinical lipidology (J Clin Lipidol) Vol. 3 Issue 2 Pg. 125-37 (Apr 2009) ISSN: 1933-2874 [Print] United States
• PMID: 21291802 (Publication Type: Journal Article)