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.


OBJECTIVE
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.
Pepine
Carl J
CJ
Division of Cardiovscular Medicine, The University of Florida, Gainesville, Florida.
Jacobson
Terry A
TA
Department of Medicine, Emory University, Atlanta, Georgia.
Carlson
Dawn M
DM
Abbott, Abbott Park, Illinois.
Kelly
Maureen T
MT
Abbott, Abbott Park, Illinois.
Setze
Carolyn M
CM
Abbott, Abbott Park, Illinois.
Gold
Alex
A
AstraZeneca, Wilmington, Delaware.
Stolzenbach
James C
JC
Abbott, Abbott Park, Illinois.
Williams
Laura A
LA
Abbott, Abbott Park, Illinois.
D000368:Aged; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D050171:Dyslipidemias / Q000097:blood / Q000188:drug therapy*; D005260:Female; D011345:Fenofibrate / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005464:Fluorobenzenes / Q000008:administration & dosage / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D008055:Lipids / Q000097:blood*; D008297:Male; D011743:Pyrimidines / Q000008:administration & dosage / Q000627:therapeutic use*; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000960:Hypolipidemic Agents; D008055:Lipids; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium; C006012:fenofibric acid; D011345:Fenofibrate