New Fixed-Dose Combinations of Fenofibrate/Simvastatin Therapy Significantly Improve the Lipid Profile of High-Risk Patients with Mixed Dyslipidemia Versus Monotherapies

Guidelines propose additional therapy to statin to treat elevated triglycerides (TG) and low high-density lipoprotein cholesterol (HDLC) in dyslipidemic patients. We evaluated the effects of new fixed-dose combinations (FDC) of fenofibrate/simvastatin on plasma lipids versus simvastatin or fenofibra...

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Bibliographic Details
Published in:	Cardiovascular therapeutics Vol. 33; no. 6; p. 329
Main Authors:	Foucher, Christelle, Aubonnet, Patrick, Reichert, Petr, Berli, Mario, Schaeffer, Axel, Calvo Vargas, Cesar Gonzalo, Lochocka, Anna, Belenky, Dmitry, Koch, Hans-Friedrich
Format:	Journal Article
Language:	English
Published:	England 01-12-2015
Subjects:	Aged Biomarkers - blood C-Reactive Protein - metabolism Cholesterol, HDL - blood Cystatin C - blood Double-Blind Method Drug Combinations Dyslipidemias - blood Dyslipidemias - diagnosis Dyslipidemias - drug therapy Female Fenofibrate - adverse effects Fenofibrate - therapeutic use Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use Male Middle Aged Simvastatin - adverse effects Simvastatin - therapeutic use Time Factors Treatment Outcome Triglycerides - blood Fenofibrate Cardiovascular disease Mixed dyslipidemia Fixed-dose combination Simvastatin
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Summary:	Guidelines propose additional therapy to statin to treat elevated triglycerides (TG) and low high-density lipoprotein cholesterol (HDLC) in dyslipidemic patients. We evaluated the effects of new fixed-dose combinations (FDC) of fenofibrate/simvastatin on plasma lipids versus simvastatin or fenofibrate monotherapies. Subjects with mixed dyslipidemia at high or very high cardiovascular risk on stable statin therapy for at least 3 months were included in a randomized, double-blind, active-control, parallel-group study. Patients were treated with FDC fenofibrate/simvastatin 145/20 mg or 145/40 mg, simvastatin 20 mg or 40 mg, or fenofibrate 145 mg for 12 weeks. Plasma lipids, C-reactive protein, and cystatin C were measured before and after treatments. Differences in % changes were compared between FDC fenofibrate/simvastatin and monotherapies. Significant differences between FDC fenofibrate/simvastatin and simvastatin monotherapies were observed for the % change of TG (LS mean difference [two-sided 95% CI]: -32.2% [-38.6%, -25.8%], P < 0.001) and HDL-C (7.5% [4.7%, 10.2%], P < 0.001). A significant difference between the FDC fenofibrate/simvastatin and fenofibrate was observed for LDLC % changes (-34.7% [-40.8%, -28.5%], P < 0.001). Significant differences between FDC fenofibrate/simvastatin and their respective monotherapies were also observed for Apo B and non-HDLC % changes. The FDC were well tolerated with a similar safety profile compared with monotherapies. FDC fenofibrate/simvastatin are effective and well-tolerated therapies to improve the TG and HDLC profile in high-risk patients with mixed dyslipidemia.
ISSN:	1755-5922
DOI:	10.1111/1755-5922.12148