Effects of Evolocumab on Low-Density Lipoprotein Cholesterol, Non-High Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a) by Race and Ethnicity: A Meta-Analysis of Individual Participant Data From Double-Blind and Open-Label Extension Studies

Abstract

Background Prevalence of cardiovascular disease risk factors and rates of atherosclerotic cardiovascular disease outcomes vary across racial/ethnic groups. This analysis examined the effects of evolocumab on LDL-C (low-density lipoprotein cholesterol) levels and LDL-C goals achievement by race/ethnicity. Methods and Results Data from 15 phase 2 and 3 studies of treatment with evolocumab versus placebo or ezetimibe were pooled (n=7669). Results were analyzed by participant clinical characteristics and by self-identified race/ethnicity. Key outcomes included percent change from baseline in LDL-C, achievement of LDL-C <70 mg/dL, and LDL-C reduction of ≥50% at 12 weeks and at 1 to 5 years. Across 12-week studies, mean percent change in LDL-C from baseline in evolocumab-treated participants was -52% to -59% for White and -46% to -67% for non-White participants, across clinical characteristics groups. LDL-C <70 mg/dL was achieved in 43% to 84% and 62% to 94% and LDL-C reduction of ≥50% in 63% to 78% and 58% to 86%, respectively. In 1- to 5-year studies, mean percent change in LDL-C was -46% to -52% for White and -49% to -55% for non-White participants. LDL-C <70 mg/dL was achieved in 53% to 84% and 66% to 77%, and LDL-C reduction of ≥50% in 53% to 67% and 58% to 68%, respectively. The treatment effect on mean percent change in LDL-C differed only in participants with type 2 diabetes mellitus, with a larger reduction in Asian participants. The qualitative interaction P values were nonsignificant, indicating consistent directionality of effect. Conclusions Similar reduction in LDL-C levels with evolocumab was observed across racial/ethnic groups in 12-week and 1- to 5-year studies. Among those with diabetes mellitus, Asian participants had greater LDL-C reduction.

Keywords: ethnicity; evolocumab; lipids and lipoproteins; race.

Conflict of interest statement

Rodriguez has received grant funding from Amgen Inc. López, Monsalvo, and Wu are employees and shareholders of Amgen Inc. Ferdinand is a consultant for Sanofi, Amgen Inc., Boehringer Ingelheim, Eli Lilly, and Janssen. Daviglus has no disclosures to report.

Figures

Figure 1. Regional enrollment of evolocumab‐treated patients in the double‐blind studies in this analysis by race and ethnicity.

Nonpresented racial/ethnic groups include those who self‐identified as American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, and Mixed Race.

Figure 2. Mean percent change from baseline in LDL‐C with evolocumab, ezetimibe, or placebo across racial/ethnic groups.

Dots represent the mean value and bars represent the 95% CIs. *Mean percent change in LDL‐C from baseline (95% CI) for the evolocumab and ezetimibe treatment arms were: −46.0% (−58.3, −33.6) and −22.1% (−109.3, 65.1), respectively, for Non‐Hispanic Black or African American persons; −54.6% (−85.3, −24.0) and −19.0% (−33.9, −4.2), respectively, for Hispanic or Latino persons; and −49.0% (−79.7, −18.2) and −23.5% (−42.5, −4.6), respectively, for Asian persons. HeFH indicates heterozygous familial hypercholesterolemia; and LDL‐C, low‐density lipoprotein cholesterol.