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

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          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 © 2010 Wiley Periodicals, Inc.

          Financial support for the studies was provided by Abbott and AstraZeneca. Dr. Pepine has served as a consultant for Abbott, Angioblast, Eli Lilly, Forest, Medtelligence, NicOx, Novartis, Sanofi‐Aventis, and SLACK, Inc.; has received research grants from Baxter, Bioheart, Inc., GlaxoSmithKline, and Pfizer; and has received unrestricted educational grants from AstraZeneca, AtCor Medical, Daiichi Sankyo, Eli Lilly, Pfizer, sanofi aventis, and Schering Plough. Dr. Jacobson is a consultant for Abbott, AstraZeneca, GlaxoSmithKline, Merck, and Schering Plough. Dr. Carlson, Dr. Kelly, Ms. Setze, Dr. Stolzenbach, and Dr. Williams are Abbott employees and stockholders. Dr. Gold is an AstraZeneca employee and stockholder.

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          Author and article information

          Contributors
          carl.pepine@medicine.ufl.edu
          Journal
          Clin Cardiol
          Clin Cardiol
          10.1002/(ISSN)1932-8737
          CLC
          Clinical Cardiology
          Wiley Periodicals, Inc. (New York )
          0160-9289
          1932-8737
          19 October 2010
          October 2010
          : 33
          : 10 ( doiID: 10.1002/clc.v33:10 )
          : 609-619
          Affiliations
          [ 1 ]Division of Cardiovscular Medicine, The University of Florida, Gainesville, Florida
          [ 2 ]Department of Medicine, Emory University, Atlanta, Georgia
          [ 3 ]Abbott, Abbott Park, Illinois
          [ 4 ]AstraZeneca, Wilmington, Delaware
          Author notes
          [*] [* ]Division of Cardiovascular Medicine 1600 SW Archer Road, Box 100277 Gainesville, FL 32610‐0277
          Article
          PMC6653092 PMC6653092 6653092 CLC20830
          10.1002/clc.20830
          6653092
          20960535
          b0a7fedb-1c7a-40b0-b909-680b4a707a97
          Copyright © 2010 Wiley Periodicals, Inc.
          History
          : 05 May 2010
          : 14 July 2010
          Page count
          Figures: 2, Tables: 3, References: 43, Pages: 11
          Categories
          Clinical Investigation
          Clinical Investigations
          Custom metadata
          2.0
          October 2010
          Converter:WILEY_ML3GV2_TO_NLMPMC version:5.6.2.1 mode:remove_FC converted:09.05.2019

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