文献检索文档翻译深度研究
Suppr Zotero 插件Zotero 插件
邀请有礼套餐&价格历史记录

新学期,新优惠

限时优惠:9月1日-9月22日

30天高级会员仅需29元

1天体验卡首发特惠仅需5.99元

了解详情
不再提醒
插件&应用
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
高级版
套餐订阅购买积分包
AI 工具
文献检索文档翻译深度研究
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2025

在PROFICIO研究的患者亚组中,依洛尤单抗治疗低密度脂蛋白胆固醇(LDL-C)的反应一致:一项对来自3期研究的3146例患者的汇总分析

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

作者信息

Stroes Erik, Robinson Jennifer G, Raal Frederick J, Dufour Robert, Sullivan David, Kassahun Helina, Ma Yuhui, Wasserman Scott M, Koren Michael J

机构信息

Department of Vascular Medicine, Academic Medical Center of Amsterdam, Amsterdam, Netherlands.

Departments of Epidemiology and Medicine, University of Iowa, Iowa City, Iowa.

出版信息

Clin Cardiol. 2018 Oct;41(10):1328-1335. doi: 10.1002/clc.23049. Epub 2018 Oct 21.


DOI:10.1002/clc.23049
PMID:30120772
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6489970/
Abstract

BACKGROUND: Evolocumab significantly lowers low-density lipoprotein cholesterol (LDL-C) when dosed 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM) subcutaneously. HYPOTHESIS: LDL-C changes are comparable among different patient subgroups in a pooled analysis of data from phase 3 trials. METHODS: A total of 3146 patients received ≥1 dose of evolocumab or control in four 12-week phase 3 studies. Percent change from baseline in LDL-C for evolocumab 140 mg Q2W or 420 mg QM vs control was reported as the average of week 10 and 12 values. Quantitative and qualitative interactions between treatment group and subgroup by dose regimen were tested. RESULTS: In the pooled analysis, treatment differences vs placebo or ezetimibe were similar for both 140 mg Q2W and 420 mg QM doses across ages (<65 years, ≥65 years); gender; race (Asian, black, white, other); ethnicity (Hispanic, non-Hispanic); region (Europe, North America, Asia Pacific); glucose tolerance status (type 2 diabetes mellitus, metabolic syndrome, neither); National Cholesterol Education Program risk categories (high, moderately high, moderate, low); and European Society of Cardiology/European Atherosclerosis Society risk categories (very high, high, moderate, or low). Certain low-magnitude variations in LDL-C lowering among subgroups led to significant quantitative interaction P values that, when tested by qualitative interaction, were not significant. The incidences of adverse events were similar across groups treated with each evolocumab dosing regimen or control. CONCLUSIONS: Consistent reductions in LDL-C were observed in the evolocumab group regardless of demographic and disease characteristics.

摘要

背景:每2周皮下注射140mg(Q2W)或每月皮下注射420mg(QM)的依洛尤单抗可显著降低低密度脂蛋白胆固醇(LDL-C)水平。 假设:在3期试验数据的汇总分析中,不同患者亚组的LDL-C变化具有可比性。 方法:在四项为期12周的3期研究中,共有3146例患者接受了≥1剂依洛尤单抗或对照治疗。依洛尤单抗140mg Q2W或420mg QM与对照相比,LDL-C自基线的百分比变化报告为第10周和第12周数值的平均值。对治疗组和剂量方案亚组之间的定量和定性相互作用进行了测试。 结果:在汇总分析中,140mg Q2W和420mg QM剂量组与安慰剂或依折麦布相比,在各年龄组(<65岁、≥65岁)、性别、种族(亚洲、黑人、白人、其他)、族裔(西班牙裔、非西班牙裔)、地区(欧洲、北美、亚太地区)、糖耐量状态(2型糖尿病、代谢综合征、均无)、美国国家胆固醇教育计划风险类别(高、中度高、中度、低)以及欧洲心脏病学会/欧洲动脉粥样硬化学会风险类别(极高、高、中度或低)中的治疗差异相似。亚组间LDL-C降低幅度存在一定程度的微小差异,导致定量相互作用P值具有显著性,但经定性相互作用检验后并不显著。各依洛尤单抗给药方案组或对照组的不良事件发生率相似。 结论:无论人口统计学和疾病特征如何,依洛尤单抗组均观察到LDL-C持续降低。

相似文献

[1]
Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies.

Clin Cardiol. 2018-10

[2]
Comparison of LDL-C Reduction Using Different Evolocumab Doses and Intervals: Biological Insights and Treatment Implications.

J Cardiovasc Pharmacol Ther. 2018-9

[3]
PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial.

Lancet. 2014-10-1

[4]
Effects of evolocumab (AMG 145), a monoclonal antibody to PCSK9, in hypercholesterolemic, statin-treated Japanese patients at high cardiovascular risk--primary results from the phase 2 YUKAWA study.

Circ J. 2014

[5]
Anti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: the GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of evolocumab.

J Am Coll Cardiol. 2014-3-30

[6]
Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: the LAPLACE-2 randomized clinical trial.

JAMA. 2014-5-14

[7]
Anti-PCSK9 monotherapy for hypercholesterolemia: the MENDEL-2 randomized, controlled phase III clinical trial of evolocumab.

J Am Coll Cardiol. 2014-3-29

[8]
Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance: The GAUSS-3 Randomized Clinical Trial.

JAMA. 2016-4-19

[9]
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.

J Am Heart Assoc. 2021-1-5

[10]
Efficacy and safety of adding alirocumab to rosuvastatin versus adding ezetimibe or doubling the rosuvastatin dose in high cardiovascular-risk patients: The ODYSSEY OPTIONS II randomized trial.

Atherosclerosis. 2016-1

引用本文的文献

[1]
Sex Differences in Cardiovascular Outcomes and Cholesterol-Lowering Efficacy of PCSK9 Inhibitors: Systematic Review and Meta-Analysis.

JACC Adv. 2023-10-28

[2]
PCSK-9 Inhibitors and Cardiovascular Outcomes: A Systematic Review With Meta-Analysis.

Cureus. 2023-10-6

[3]
Efficacy and Safety of Evolocumab in Chinese Patients with Primary Hypercholesterolemia and Mixed Dyslipidemia: 12-Week Primary Results of the HUA TUO Randomized Clinical Trial.

Cardiol Ther. 2023-6

[4]
Cost-Effectiveness Analysis of Evolocumab for the Treatment of Dyslipidemia in the Kingdom of Saudi Arabia.

Pharmacoecon Open. 2022-3

[5]
Effects of evolocumab in individuals with type 2 diabetes with and without atherogenic dyslipidemia: An analysis from BANTING and BERSON.

Cardiovasc Diabetol. 2021-4-30

[6]
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.

J Am Heart Assoc. 2021-1-5

[7]
PCSK9 Monoclonal Antibodies: An Overview.

Heart Views. 2020

[8]
Efficacy and safety of PCSK9 monoclonal antibodies: an evidence-based review and update.

J Drug Assess. 2020-8-11

[9]
Effects of evolocumab therapy and low LDL-C levels on vitamin E and steroid hormones in Chinese and global patients with type 2 diabetes.

Endocrinol Diabetes Metab. 2020-3-6

[10]
Proprotein convertase subtilisin/Kexin type-9 (PCSK-9) inhibitors induced liver injury - a retrospective analysis.

J Community Hosp Intern Med Perspect. 2020-2-10

本文引用的文献

[1]
2017 Focused Update of the 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways.

J Am Coll Cardiol. 2017-9-5

[2]
2016 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult.

Can J Cardiol. 2016-11

[3]
Independent Link Between Levels of Proprotein Convertase Subtilisin/Kexin Type 9 and FABP4 in a General Population Without Medication.

Am J Cardiol. 2016-7-15

[4]
Achievement of dual low-density lipoprotein cholesterol and high-sensitivity C-reactive protein targets more frequent with the addition of ezetimibe to simvastatin and associated with better outcomes in IMPROVE-IT.

Circulation. 2015-9-1

[5]
PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial.

Lancet. 2014-10-1

[6]
Very low levels of atherogenic lipoproteins and the risk for cardiovascular events: a meta-analysis of statin trials.

J Am Coll Cardiol. 2014-8-5

[7]
Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: the LAPLACE-2 randomized clinical trial.

JAMA. 2014-5-14

[8]
Anti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: the GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of evolocumab.

J Am Coll Cardiol. 2014-3-30

[9]
Anti-PCSK9 monotherapy for hypercholesterolemia: the MENDEL-2 randomized, controlled phase III clinical trial of evolocumab.

J Am Coll Cardiol. 2014-3-29

[10]
A 52-week placebo-controlled trial of evolocumab in hyperlipidemia.

N Engl J Med. 2014-3-29

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

推荐工具

医学文档翻译智能文献检索