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Author Notes:

Carl J. Pepine, MD Division of Cardiovascular Medicine 1600 SW Archer Road, Box 100277 Gainesville, FL 32610-0277 carl.pepine@medicine.ufl.edu

The authors would like to thank Hsiaoming Sun, MS, and Aditya Lele, MS, of Abbott for providing assistance with statistical analyses; Noreen Travers, RN, MSN, and Lura Morris, BA, of Abbott for providing assistance with clinical study management; and Erin Blondell, PhD, of Abbott for providing assistance with the writing and preparation of this manuscript.

Subject:

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

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

Tools:

Journal Title:

Clinical Cardiology

Volume:

Volume 33, Number 10

Publisher:

, Pages 609-619

Type of Work:

Article | Final Publisher PDF

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.

Copyright information:

© 2010 Wiley Periodicals, Inc.

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