Effects of combination therapy with rosuvastatin and fenofibric acid in patients with mixed dyslipidemia and high-sensitivity C-reactive protein (≥ 2 mg/L). [email protected].

Abstract

BACKGROUND:

Elevated levels of high-sensitivity C-reactive protein (hsCRP) correlate with an increased risk for cardiovascular events. Combination therapy with a statin and a fibrate may be more effective than statin monotherapy for reducing hsCRP, especially in patients with mixed dyslipidemia.

OBJECTIVE:

To characterize the treatment effects of rosuvastatin and fenofibric acid combination therapy compared with individual monotherapies in mixed dyslipidemic patients with baseline hsCRP ≥2 mg/L versus <2 mg/L and to determine the effects of long-term treatment with rosuvastatin and fenofibric acid combination therapy on hsCRP and other lipids for patients with hsCRP ≥2 mg/L after treatment with rosuvastatin monotherapy.

METHODS:

Data for the post hoc analysis were derived from two 12-week controlled studies and a 52-week extension study. Patients were treated with fenofibric acid 135 mg; rosuvastatin 5, 10, 20, or 40 mg; or rosuvastatin 5, 10, or 20 mg and fenofibric acid 135 mg in the controlled studies; and with rosuvastatin 20 mg and fenofibric acid 135 mg in the extension study.

RESULTS:

In this analysis, 65% (1416/2182) of patients had pretreatment baseline hsCRP ≥2 mg/L. Among all treatment groups, larger decreases in hsCRP were observed in patients with greater baseline hsCRP; however, improvements in other lipids/apolipoprotein were comparable between the baseline hsCRP categories. Among patients with high hsCRP (≥2 mg/L) remaining after 12 weeks of rosuvastatin 10, 20, or 40 mg monotherapy, hsCRP was reduced by ∼36% after switching to rosuvastatin 20 mg and fenofibric acid 135 mg for up to 52 weeks, and ∼36% of patients shifted from hsCRP ≥2 mg/L to <2 mg/L.

CONCLUSIONS:

Combination therapy with rosuvastatin and fenofibric acid may be effective for improving the inflammatory biomarker, hsCRP as well as other lipid abnormalities in patients with mixed dyslipidemia and high hsCRP.

• Authors: Christie M Ballantyne, Michael H Davidson, Carolyn M Setze, Maureen T Kelly
• Journal: Journal of clinical lipidology (J Clin Lipidol) 2011 Sep-Oct Vol. 5 Issue 5 Pg. 401-7 ISSN: 1933-2874 [Print] United States
• PMID: 21981842 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011 National Lipid Association. Published by Elsevier Inc. All rights reserved.

Chemical References

• Cholesterol, HDL
• Cholesterol, LDL
• Fluorobenzenes
• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Pyrimidines
• Sulfonamides
• Triglycerides
• Rosuvastatin Calcium
• C-Reactive Protein
• fenofibric acid
• Fenofibrate

Topics

• Adult
• Aged
• C-Reactive Protein (analysis)
• Cholesterol, HDL (blood)
• Cholesterol, LDL (blood)
• Drug Administration Schedule
• Drug Therapy, Combination
• Dyslipidemias (drug therapy)
• Female
• Fenofibrate (analogs & derivatives, therapeutic use)
• Fluorobenzenes (therapeutic use)
• Humans
• Hydroxymethylglutaryl-CoA Reductase Inhibitors (therapeutic use)
• Male
• Middle Aged
• Pyrimidines (therapeutic use)
• Risk
• Rosuvastatin Calcium
• Sulfonamides (therapeutic use)
• Triglycerides (blood)