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

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

Research output: Contribution to journalArticlepeer-review

20 Scopus citations

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) ≥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-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.

Original languageEnglish
Pages (from-to)125-137
Number of pages13
JournalJournal of Clinical Lipidology
Volume3
Issue number2
DOIs
StatePublished - Apr 1 2009
Externally publishedYes

Keywords

  • Data pooling
  • Dyslipidemia
  • Fenofibric acid
  • Fibrates
  • HDL cholesterol
  • Hydroxymethylglutaryl-CoA reductase inhibitors
  • LDL cholesterol
  • Triglycerides

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