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

Lipids in Health and Disease

Research

Krishnaji R. Kulkarni¹  Peter P. Toth²  Seth S. Martin³  Steven R. Jones³  Parag H. Joshi⁴  Poulabi Banerjee⁵  Sara C. Hamon⁵  Corinne Hanotin⁶  Eli M. Roth⁷  James M. McKenney⁸ 

[1] Atherotech, Birmingham, AL, USA;CGH Medical Center, 101 East Miller Rd, 61081, Sterling, Illinois, USA;University of Illinois School of Medicine, Peoria, IL, USA;Johns Hopkins University School of Medicine, Baltimore, MD, USA;Johns Hopkins University School of Medicine, Baltimore, MD, USA;Johns Hopkins University School of Medicine, Baltimore, MD, USA;University of Texas Southwestern Medical Center, Dallas, TX, USA;Regeneron, Tarrytown, NY, USA;Sanofi, Paris, France;The Sterling Research Group, Cincinnati, OH, USA;Virginia Commonwealth University, Richmond, VA, USA;

关键词: Alirocumab;    Hypercholesterolaemia;    Lipoprotein subfraction;    PCSK9;    VAP;   

DOI  :  10.1186/s12944-016-0197-4

 received in 2015-10-31, accepted in 2016-02-05,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundThe effect of alirocumab on potentially atherogenic lipoprotein subfractions was assessed in a post hoc analysis using the vertical auto profile (VAP) method.MethodsPatients 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.ResultsAlirocumab 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.ConclusionAlirocumab achieved reductions across a spectrum of atherogenic lipoproteins in patients receiving background statin therapy.Trial registrationClinicaltrials.gov identifiers: NCT01288443, NCT01288469, NCT01266876

【 授权许可】

CC BY   
© Toth et al. 2016