Open AccessNew Fixed‐Dose Combinations of Fenofibrate/Simvastatin Therapy Significantly Improve the Lipid Profile of High‐Risk Patients with Mixed Dyslipidemia Versus Monotherapies
Author(s) -
Foucher Christelle,
Aubonnet Patrick,
Reichert Petr,
Berli Mario,
Schaeffer Axel,
Calvo Vargas Cesar Gonzalo,
Lochocka Anna,
Belenky Dmitry,
Koch HansFriedrich
Publication year - 2015
Publication title -
cardiovascular therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.818
H-Index - 46
eISSN - 1755-5922
pISSN - 1755-5914
DOI - 10.1111/1755-5922.12148
Subject(s) - medicine , fenofibrate , simvastatin , dyslipidemia , fixed dose combination , lipid profile , pharmacology , cholesterol , obesity
Summary Aims 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. Methods 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. Results 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. Conclusions FDC fenofibrate/simvastatin are effective and well‐tolerated therapies to improve the TG and HDLC profile in high‐risk patients with mixed dyslipidemia.