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依洛尤单抗在瑞士多中心前瞻性观察研究中的疗效、依从性和安全性。

Effectiveness, Adherence, and Safety of Evolocumab in a Swiss Multicenter Prospective Observational Study.

机构信息

Center for Primary Care and Public Health, University of Lausanne, Lausanne, Switzerland.

Division of Cardiology, Department of Medicine, Geneva University Hospital, Geneva, Switzerland.

出版信息

Adv Ther. 2022 Jan;39(1):504-517. doi: 10.1007/s12325-021-01962-w. Epub 2021 Nov 18.


DOI:10.1007/s12325-021-01962-w
PMID:34796465
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8799585/
Abstract

INTRODUCTION: The aims of this study were to describe patient characteristics, lipid parameters, lipid-lowering drug use, and safety of patients receiving evolocumab in a real-world clinical setting. METHODS: We conducted a 1-year multicenter observational study of adults using evolocumab with confirmed atherosclerotic cardiovascular disease (CVD) or at high cardiovascular risk, and elevated LDL-C despite maximally tolerated statin doses. An e-health application optionally supported patient management. The primary outcome was change in lipid parameters over time. The secondary outcomes included evolocumab safety. RESULTS: Of 100 participants, 81% had pre-existing CVD, 71% self-reported statin-related muscle symptoms, 44% received statins. All patients received evolocumab, 65% were PCSK9i pre-treated at baseline. PCSK9i-naïve patients achieved a mean LDL-C reduction of 60% within 3 months of evolocumab treatment, which was maintained thereafter; 74% achieved LDL-C < 1.8 mmol/L at least once during observation, 69% attained < 1.4 mmol/L. In PCSK9i pre-treated patients, LDL-C remained stable throughout; 79% and 74% attained < 1.8 mmol/L and < 1.4 mmol/L, respectively, at least once. Goal attainment was higher with any combination of evolocumab, statin, and/or ezetimibe. Overall, 89% self-reported full evolocumab adherence. Treatment-emergent adverse events (TEAE) were reported in 30% of patients, two serious TEAEs occurred in one patient; three patients discontinued evolocumab because of TEAEs. CONCLUSION: In real-world clinical practice, evolocumab was mainly used in patients with statin intolerance and pre-existing CVD. In this population, adherence to evolocumab and low LDL-C levels were maintained over 1 year, with better LDL-C goal achievement in patients using evolocumab in combination with other lipid-lowering drugs. Safety of evolocumab was similar to that documented in randomized controlled trials.

摘要

简介:本研究旨在描述接受依洛尤单抗治疗的患者的临床特征、血脂参数、降脂药物使用情况及安全性,该研究为真实世界临床环境下的研究。

方法:我们进行了一项为期 1 年的多中心观察性研究,纳入使用依洛尤单抗治疗的患有动脉粥样硬化性心血管疾病(CVD)或心血管疾病风险高、最大耐受剂量他汀类药物治疗后 LDL-C 仍升高的成年患者。可选电子健康应用程序支持患者管理。主要结局是随时间变化的血脂参数变化。次要结局包括依洛尤单抗的安全性。

结果:在 100 名参与者中,81%有既往 CVD,71%自述他汀类药物相关肌肉症状,44%接受他汀类药物治疗。所有患者均接受依洛尤单抗治疗,65%患者基线时为 PCSK9i 预处理。PCSK9i 初治患者在依洛尤单抗治疗 3 个月内 LDL-C 降低 60%,此后保持稳定;74%患者在观察期间至少有一次 LDL-C<1.8mmol/L,69%患者 LDL-C<1.4mmol/L。在 PCSK9i 预处理患者中,LDL-C 始终保持稳定;79%和 74%患者至少有一次 LDL-C<1.8mmol/L 和<1.4mmol/L。依洛尤单抗、他汀类药物和/或依折麦布联合使用时,达标率更高。总体而言,89%患者报告了依洛尤单抗的完全依从性。30%的患者报告了治疗中出现的不良事件(TEAE),1 名患者发生 2 例严重 TEAE;3 名患者因 TEAE 停止使用依洛尤单抗。

结论:在真实世界临床实践中,依洛尤单抗主要用于他汀类药物不耐受和既往 CVD 的患者。在该人群中,依洛尤单抗的依从性和 LDL-C 水平在 1 年内保持稳定,与单独使用降脂药物相比,联合使用依洛尤单抗和其他降脂药物可更好地实现 LDL-C 目标。依洛尤单抗的安全性与随机对照试验中记录的安全性相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef63/8799585/0715ba276020/12325_2021_1962_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef63/8799585/f28024d3663a/12325_2021_1962_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef63/8799585/0715ba276020/12325_2021_1962_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef63/8799585/f28024d3663a/12325_2021_1962_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef63/8799585/0715ba276020/12325_2021_1962_Fig2_HTML.jpg

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引用本文的文献

[1]
LDL-C Reduction with Evolocumab Among Patients with ASCVD in China: Real-World Evidence from Tianjin Metropolitan Area.

Adv Ther. 2025-6

[2]
Real-World safety and effectiveness of evolocumab in primary hypercholesterolemia and mixed dyslipidemia in Saudi Arabia.

Saudi Pharm J. 2024-12

[3]
PCSK9 Inhibitors and Infection-Related Adverse Events: A Pharmacovigilance Study Using the World Health Organization VigiBase.

Drugs Real World Outcomes. 2024-9

[4]
Evolocumab use in clinical practice in Switzerland: final data of the observational HEYMANS cohort study.

Ther Adv Cardiovasc Dis. 2024

[5]
Real-World Insights into Evolocumab Use in Patients with Hyperlipidemia Across Five Countries: Analysis from the ZERBINI Study.

Cardiol Ther. 2023-12

[6]
Novel Insights into the Management of Patients with Very High Cardiovascular Risk Eligible for PCSK9 Inhibitor Treatment: Baseline Findings from the PERI-DYS Study.

Cardiovasc Drugs Ther. 2024-2

[7]
PCSK9 Inhibitors in the Management of Cardiovascular Risk: A Practical Guidance.

Vasc Health Risk Manag. 2022

本文引用的文献

[1]
Statin treatment and LDL target value achievement in Swiss general practice - a retrospective observational study.

Swiss Med Wkly. 2020-5-18

[2]
Ezetimibe Use and LDL-C Goal Achievement: A Retrospective Database Analysis of Patients with Clinical Atherosclerotic Cardiovascular Disease or Probable Heterozygous Familial Hypercholesterolemia.

J Manag Care Spec Pharm. 2017-9-25

[3]
Comprehensive efforts to increase adherence to statin therapy.

Eur Heart J. 2017-8-21

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