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依洛尤单抗对不同种族和民族的低密度脂蛋白胆固醇、非高密度脂蛋白胆固醇、载脂蛋白 B 和脂蛋白(a)的影响:来自双盲和开放标签延伸研究的个体参与者数据的荟萃分析。

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.

机构信息

University of Illinois at Chicago IL.

Tulane University New Orleans LA.

出版信息

J Am Heart Assoc. 2021 Jan 5;10(1):e016839. doi: 10.1161/JAHA.120.016839. Epub 2020 Dec 16.


DOI:10.1161/JAHA.120.016839
PMID:33325247
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7955505/
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 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.

摘要

背景:心血管疾病风险因素的流行率和动脉粥样硬化性心血管疾病结局的发生率在不同种族/民族群体之间存在差异。本分析检查了依洛尤单抗对低密度脂蛋白胆固醇(LDL-C)水平和 LDL-C 达标率的影响按种族/民族划分。

方法和结果:来自 15 项依洛尤单抗与安慰剂或依折麦布治疗的 2 期和 3 期研究的数据进行了汇总(n=7669)。根据参与者的临床特征和自我认定的种族/民族对结果进行了分析。主要结局包括 LDL-C 从基线的百分比变化、LDL-C<70mg/dL 的达标率以及 12 周和 1 至 5 年时 LDL-C 降低≥50%的比例。在 12 周的研究中,依洛尤单抗治疗参与者的 LDL-C 从基线的平均百分比变化为:白人参与者为-52%至-59%,非白人参与者为-46%至-67%,跨越各临床特征组。LDL-C<70mg/dL 的达标率分别为 43%至 84%和 62%至 94%,LDL-C 降低≥50%的比例分别为 63%至 78%和 58%至 86%。在 1 至 5 年的研究中,白人参与者的 LDL-C 从基线的平均百分比变化为-46%至-52%,非白人参与者为-49%至-55%。LDL-C<70mg/dL 的达标率分别为 53%至 84%和 66%至 77%,LDL-C 降低≥50%的比例分别为 53%至 67%和 58%至 68%。在 2 型糖尿病患者中,依洛尤单抗对 LDL-C 平均百分比变化的治疗效果仅存在差异,亚洲患者的降幅更大。定性交互值无统计学意义,表明作用方向一致。

结论:在 12 周和 1 至 5 年的研究中,依洛尤单抗在不同种族/民族群体中观察到 LDL-C 水平的相似降低。在患有糖尿病的患者中,亚洲患者的 LDL-C 降低幅度更大。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8cc4/7955505/64019f8df451/JAH3-10-e016839-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8cc4/7955505/962829066c93/JAH3-10-e016839-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8cc4/7955505/64019f8df451/JAH3-10-e016839-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8cc4/7955505/962829066c93/JAH3-10-e016839-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8cc4/7955505/64019f8df451/JAH3-10-e016839-g002.jpg

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[1]
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.

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Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies.

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