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

• Published in: Clinical cardiology (Mahwah, N.J.) N.J.), 2010-10, Vol.33 (10), p.609-619
• Main Authors: Pepine, Carl J., Jacobson, Terry A., Carlson, Dawn M., Kelly, Maureen T., Setze, Carolyn M., Gold, Alex, Stolzenbach, James C., Williams, Laura A.
• Format: Article
• Language: English
• Subjects: Age; Aged; Biological and medical sciences; Cardiology. Vascular system; Cardiovascular disease; Cholesterol; Clinical Investigation; Clinical Investigations; Creatinine; Dose-Response Relationship, Drug; Drug dosages; Drug Therapy, Combination; Dyslipidemias - blood; Dyslipidemias - drug therapy; FDA approval; Female; Fenofibrate - administration & dosage; Fenofibrate - analogs & derivatives; Fenofibrate - therapeutic use; Fluorobenzenes - administration & dosage; Fluorobenzenes - therapeutic use; Follow-Up Studies; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Hypolipidemic Agents - administration & dosage; Hypolipidemic Agents - therapeutic use; Lipids; Lipids - blood; Lipoproteins; Male; Medical sciences; Metabolic disorders; Pyrimidines - administration & dosage; Pyrimidines - therapeutic use; Rosuvastatin Calcium; Statins; Sulfonamides - administration & dosage; Sulfonamides - therapeutic use; Treatment Outcome
• ISSN: 0160-9289; 1932-8737
• DOI: 10.1002/clc.20830

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.