Details

Autor(en) / Beteiligte

• Foucher, Christelle
• Aubonnet, Patrick
• Reichert, Petr
• Berli, Mario
• Schaeffer, Axel
• Calvo Vargas, Cesar Gonzalo
• Lochocka, Anna
• Belenky, Dmitry
• Koch, Hans‐Friedrich

Titel

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

Ist Teil von

• Cardiovascular therapeutics, 2015-12, Vol.33 (6), p.329-337

Ort / Verlag

England: Hindawi Limited

Erscheinungsjahr

2015

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• 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.