TY - JOUR
T1 - Effect of evolocumab on non-high-density lipoprotein cholesterol, apolipoprotein b, and lipoprotein(A)
T2 - A pooled analysis of phase 2 and phase 3 studies
AU - Toth, Peter P.
AU - Jones, Steven R.
AU - Monsalvo, Maria Laura
AU - Elliott-Davey, Mary
AU - Lóopez, J. Antonio G.
AU - Banach, Maciej
N1 - Funding Information:
Toth is a member of the speaker’s bureau for Amarin, Amgen, Kowa, Merck, Novo-Nordisk, Regeneron, and Sanofi; he is a consultant to Amarin, Amgen, Novo-Nordisk, Resverlogix, and Theravance. Jones receives grant support from the David and June Trone Family Foundation (significant). Monsalvo, Elliott-Davey, and López are employees of and stockholders in Amgen Inc (significant). Banach has received research grant (s)/support from Sanofi and Valeant and has served as a consultant for Mylan (modest), Amgen (significant), KRKA (modest), Polfarmex (significant), Polpharma (modest), Sanofi-Aventis (significant), Servier (modest), and Esperion (modest).
Funding Information:
The authors thank Maya Shehayeb, of Amgen Inc., for medical writing and editorial support and Ben Wang and Joshua Givens, on behalf of Amgen Inc., for statistical support. This work was supported by Amgen Inc.
Funding Information:
This work was supported by Amgen Inc.
Publisher Copyright:
© 2020 The Authors and Amgen Inc. Published on behalf of the American Heart Association, Inc., by Wiley.
PY - 2020
Y1 - 2020
N2 - 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.
AB - 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.
KW - Lipids and lipoproteins
KW - Low-density lipoprotein cholesterol
KW - apolipoprotein
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U2 - 10.1161/JAHA.119.014129
DO - 10.1161/JAHA.119.014129
M3 - Article
C2 - 32114889
AN - SCOPUS:85080840659
SN - 2047-9980
VL - 9
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
IS - 5
M1 - e014129
ER -