title: Effect of alirocumab on specific lipoprotein non-high-density lipoprotein cholesterol and subfractions as measured by the vertical auto profile method: analysis of 3 randomized trials versus placebo.
abstract: BACKGROUND
  The effect of alirocumab on potentially atherogenic lipoprotein subfractions was assessed in a post hoc analysis using the vertical auto profile (VAP) method.
  
  
  METHODS
  Patients from three Phase II studies with low-density lipoprotein cholesterol (LDL-C) ≥ 2.59 mmol/L (100 mg/dL) at baseline on stable statin therapy were randomised to receive subcutaneous alirocumab 50-150 mg every 2 weeks (Q2W) or 150-300 mg every 4 weeks (according to study) or placebo for 8-12 weeks. Samples from patients treated with alirocumab 150 mg Q2W (n = 74; dose common to all three trials) or placebo (n = 71) were analysed by VAP. Percent change in lipoprotein subfractions with alirocumab vs. placebo was analysed at Weeks 6, 8 or 12 using analysis of covariance.
  
  
  RESULTS
  Alirocumab significantly reduced LDL-C and the cholesterol content of subfractions LDL1, LDL2 and LDL3+4. Significant reductions were also observed in triglycerides, apolipoproteins CII and CIII and the cholesterol content of very low-density, intermediate-density, and remnant lipoproteins.
  
  
  CONCLUSIONS
  Alirocumab achieved reductions across a spectrum of atherogenic lipoproteins in patients receiving background statin therapy.
  
  
  BACKGROUND
  Clinicaltrials.gov identifiers: NCT01288443, NCT01288469, NCT01266876.
authors.affiliation: CGH Medical Center, 101 East Miller Rd, Sterling, Illinois, 61081, USA. peter.toth@cghmc.com.|University of Illinois School of Medicine, Peoria, IL, USA. peter.toth@cghmc.com.|Johns Hopkins University School of Medicine, Baltimore, MD, USA. peter.toth@cghmc.com.
authors.forename: Peter P
authors.initials: PP
authors.lastname: Toth
authors.affiliation: Regeneron, Tarrytown, NY, USA.
authors.forename: Sara C
authors.initials: SC
authors.lastname: Hamon
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors.forename: Steven R
authors.initials: SR
authors.lastname: Jones
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors.forename: Seth S
authors.initials: SS
authors.lastname: Martin
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, MD, USA.|University of Texas Southwestern Medical Center, Dallas, TX, USA.
authors.forename: Parag H
authors.initials: PH
authors.lastname: Joshi
authors.affiliation: Atherotech, Birmingham, AL, USA.
authors.forename: Krishnaji R
authors.initials: KR
authors.lastname: Kulkarni
authors.affiliation: Regeneron, Tarrytown, NY, USA.
authors.forename: Poulabi
authors.initials: P
authors.lastname: Banerjee
authors.affiliation: Sanofi, Paris, France.
authors.forename: Corinne
authors.initials: C
authors.lastname: Hanotin
authors.affiliation: The Sterling Research Group, Cincinnati, OH, USA.
authors.forename: Eli M
authors.initials: EM
authors.lastname: Roth
authors.affiliation: Virginia Commonwealth University, Richmond, VA, USA.
authors.forename: James M
authors.initials: JM
authors.lastname: McKenney
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D008078:Cholesterol, LDL; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy; D050356:Lipid Metabolism / Q000187:drug effects; D008074:Lipoproteins / Q000097:blood*; D008075:Lipoproteins, HDL / Q000097:blood; D008079:Lipoproteins, VLDL / Q000097:blood; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D014280:Triglycerides / Q000097:blood
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D008078:Cholesterol, LDL; D008074:Lipoproteins; D008075:Lipoproteins, HDL; D008079:Lipoproteins, VLDL; D014280:Triglycerides; C571059:alirocumab