Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies

Background Dyslipidemia guidelines recommend non-high-density lipoprotein cholesterol (non-HDL-C) and apolipoprotein B (ApoB) as additional targets of therapy and consider lipoprotein(a) a significant cardiovascular risk marker. The current analysis evaluates the effects of evolocumab on these param...

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Published in:	Journal of the American Heart Association 2020-03, Vol.9 (5), p.e014129
Main Authors:	Toth, Peter P, Jones, Steven R, Monsalvo, Maria Laura, Elliott-Davey, Mary, López, J Antonio G, Banach, Maciej
Format:	Article
Language:	eng
Subjects:	Adolescent Adult Aged Aged, 80 and over Antibodies, Monoclonal, Humanized - adverse effects Antibodies, Monoclonal, Humanized - therapeutic use Anticholesteremic Agents - adverse effects Anticholesteremic Agents - therapeutic use apolipoprotein Apolipoprotein B-100 - blood Biomarkers - blood Cholesterol, LDL - blood Clinical Trials, Phase II as Topic Clinical Trials, Phase III as Topic Down-Regulation Dyslipidemias - blood Dyslipidemias - diagnosis Dyslipidemias - drug therapy Female Humans lipids and lipoproteins Lipoprotein(a) - blood low‐density lipoprotein cholesterol Male Middle Aged Original Research Proprotein Convertase 9 - antagonists & inhibitors Randomized Controlled Trials as Topic Time Factors Treatment Outcome Young Adult
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Summary:	Background Dyslipidemia guidelines recommend non-high-density lipoprotein cholesterol (non-HDL-C) and apolipoprotein B (ApoB) as additional targets of therapy and consider lipoprotein(a) a significant cardiovascular risk marker. The current analysis evaluates the effects of evolocumab on these parameters in various patient populations over time. Methods and Results Data from 7690 patients, 4943 of whom received at least 1 dose of evolocumab, in 15 phase 2 and phase 3 studies with a duration ranging from 12 weeks to 5 years were pooled based on study length, patient population, and ezetimibe or placebo comparator groups. Patients could receive intensive statin therapy but not in the statin intolerance and monotherapy studies. The effects of evolocumab on percent change from baseline for non-HDL-C, ApoB, and lipoprotein(a) and achievement of treatment goals for non-HDL-C and ApoB were examined. Compared with placebo, evolocumab at both approved dosing regimens substantially reduced mean non-HDL-C (Q2W dose: -49% to -56%, monthly dose: -48% to -52%), mean ApoB (Q2W dose: -46% to -52%, monthly dose: -40% to -48%), and median lipoprotein(a) (Q2W dose: -22% to -38%, monthly dose: -20% to -33%) at 12 weeks. Effects on all 3 parameters persisted over 5 years. Lipid-lowering effects were consistent among the patient populations examined (hypercholesterolemia/mixed dyslipidemia, statin intolerance, heterozygous familial hypercholesterolemia, and type 2 diabetes mellitus). Conclusions In this pooled analysis, evolocumab substantially reduced non-HDL-C, ApoB, and lipoprotein(a) compared with placebo. The effect was consistent and maintained in various patient populations over 5 years.
ISSN:	2047-9980 2047-9980