title: New Fixed-Dose Combinations of Fenofibrate/Simvastatin Therapy Significantly Improve the Lipid Profile of High-Risk Patients with Mixed Dyslipidemia Versus Monotherapies.
abstract: OBJECTIVE
  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.
authors.affiliation: Clinsciences, Dijon, France.
authors.forename: Christelle
authors.initials: C
authors.lastname: Foucher
authors.affiliation: Mylan EPD, BGP Product Operations GmBH, Allschwil, Switzerland.
authors.forename: Patrick
authors.initials: P
authors.lastname: Aubonnet
authors.affiliation: Samostatna ordinace lekare specialisty - internisty, Teplice, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Reichert
authors.affiliation: Centro de Diagnóstico y Rehabilitación - CEDIR, Santa Fe, Argentina.
authors.forename: Mario
authors.initials: M
authors.lastname: Berli
authors.affiliation: Essen, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Schaeffer
authors.affiliation: Diseño y Planeación en Investigación Médica, Guadalajara, Mexico.
authors.forename: Cesar Gonzalo
authors.initials: CG
authors.lastname: Calvo Vargas
authors.affiliation: Niepubliczny Zakład Opieki Zdrowotnej Centrum Medyczne "OMEGA" Sp. z o.o.ul., Płock, Poland.
authors.forename: Anna
authors.initials: A
authors.lastname: Lochocka
authors.affiliation: Clinical Emergency Hospital, Novosibirsk, Russian Federation.
authors.forename: Dmitry
authors.initials: D
authors.lastname: Belenky
authors.affiliation: Mylan EPD, Clinical development biometrics, Hannover, Germany.
authors.forename: Hans-Friedrich
authors.initials: HF
authors.lastname: Koch
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000097:blood; D002097:C-Reactive Protein / Q000378:metabolism; D008076:Cholesterol, HDL / Q000097:blood*; D055316:Cystatin C / Q000097:blood; D004311:Double-Blind Method; D004338:Drug Combinations; D050171:Dyslipidemias / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D011345:Fenofibrate / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D019821:Simvastatin / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood*
chemical_list: D015415:Biomarkers; C525030:CST3 protein, human; D008076:Cholesterol, HDL; D055316:Cystatin C; D004338:Drug Combinations; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D014280:Triglycerides; D002097:C-Reactive Protein; D019821:Simvastatin; D011345:Fenofibrate
keywords: Cardiovascular disease; Fenofibrate; Fixed-dose combination; Mixed dyslipidemia; Simvastatin