Combination Rosuvastatin Plus Fenofibric Acid in a Cohort of Patients 65 Years or Older with Mixed Dyslipidemia: Subanalysis of Two Randomized, Controlled Studies

Background: Coronary heart disease risk increases with advancing age and is further increased in patients with mixed dyslipidemia, characterized by elevated low-density lipoprotein cholesterol (LDL-C), low high-density lipoprotein cholesterol (HDL-C), and high triglycerides (TG). Combination lipid therapy is an option; however, efficacy and safety data among elderly patients are lacking.Hypothesis: The combination of rosuvastatin and fenofibric acid (R + FA) results in more comprehensive lipid improvements than corresponding-dose monotherapies, without additional safety concerns, in elderly patients with mixed dyslipidemia.Methods: This post-hoc analysis evaluated data from patients age >= 65 years (n = 401) with mixed dyslipidemia (LDL-C >= 130 mg/dL, HDL-C <40 mg/dL [men] or <50 mg/dL [women], and TG >= 150 mg/dL) in 2 randomized studies. Patients included in this analysis received either monotherapy (as R5, 10, or 20 mg or FA(135) mg), or combination therapy with R (5, 10, or 20 mg) + F-A135 mg, for 12 weeks. Data were pooled and analyzed, and mean/median percent changes in multiple lipid parameters and biomarkers were compared.Results: Combination therapy decreased LDL-C by 31.8%-47.2% vs 10.6% with FA monotherapy (P Combination therapy also increased HDL-C by 21.9%-27.0% vs 5.9%-9.9% with P. monotherapy (P < 0.001), and decreased TG by 48.3%-53.5% vs 20.7%-32.8% with R monotherapy (P < 0.001). In general, safety profiles were consistent between combination therapy and individual monotherapies. Conclusions: In these elderly patients with mixed dyslipidemia, R 5, 10, or 20 mg in combination with FA 135 mg improved the overall lipid profile, without new or unexpected safety issues.