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

• Authors: Carl J. Pepine, University of Florida; Terry A Jacobson, Emory University; Dawn M. Carlson, Abbott; Maureen T. Kelly, Abbott; Carolyn M. Setze, Abbott; Alex Gold, AstraZeneca; James C. Stolzenbach, Abbott; Laura A. Williams, Abbott
• Journal Title: Clinical Cardiology
• Volume: Volume 33, Number 10
• Publisher: Wiley Open Access: Various Creative Commons Licenses | 2010-10-01, Pages 609-619
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1002/clc.20830
• Subjects: Health Sciences, Medicine and Surgery
• Keywords: Science & Technology; Life Sciences & Biomedicine; Cardiac & Cardiovascular Systems; Cardiovascular System & Cardiology; CORONARY-HEART-DISEASE; STATIN THERAPY; CARDIOVASCULAR EVENTS; MYOCARDIAL-INFARCTION; ELDERLY-PATIENTS; NATIONAL-HEALTH; US ADULTS; PHASE-III; RISK; CHOLESTEROL

Abstract

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 R 5, 10, or 20 mg or FA 135 mg), or combination therapy with R (5, 10, or 20 mg) + FA 135 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 < 0.001). Combination therapy also increased HDL-C by 21.9%-27.0% vs 5.9%-9.9% with R 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.