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在中国患有动脉粥样硬化性心血管疾病(ASCVD)的患者中使用依洛尤单抗降低低密度脂蛋白胆固醇(LDL-C):来自天津市区的真实世界证据。

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

作者信息

Zhao Liming, Liu Jiamei, Liu Yin, Huang Zhenna, Ye Xuxiao, Lange Jeff L, Dhalwani Nafeesa, Yang Fan, Zhang Zizhao, Chen Kangyin, Zhang Hao, Zhou Jifang

机构信息

School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, Jiangsu, China.

Center for Observational Research, Amgen China, Shanghai, China.

出版信息

Adv Ther. 2025 Jun;42(6):2874-2887. doi: 10.1007/s12325-025-03199-3. Epub 2025 Apr 25.


DOI:10.1007/s12325-025-03199-3
PMID:40279014
Abstract

INTRODUCTION: Clinical trials have shown that adding evolocumab to statin therapy reduces low-density lipoprotein cholesterol (LDL-C) levels by approximately 60%. Given differences in patient characteristics and standards of care between trial and real-world settings, we conducted a cohort study to evaluate the LDL-C reduction achieved with evolocumab in clinical practice of China. METHODS: The data source was the Tianjin Regional Healthcare Database (TRHD), which includes linked electronic health records (EHR) of public hospitals serving over 15 million residents in the Tianjin metropolitan area. The study cohort included adult patients with atherosclerotic cardiovascular disease (ASCVD) who added evolocumab to their statin therapy between 2019 and 2023. Key inclusion criteria were use of the same statin intensity before and after evolocumab initiation and available LDL-C values at baseline (within 90 days before initiation) and follow-up (15-90 days after initiation). Descriptive statistics were used to analyze LDL-C change between baseline and follow-up. To provide the context for evolocumab use and for study method assessment, we included another cohort of patients with stable statin intensity (unchanged for at least 180 days)-a cohort with minimal clinical expectation of further LDL-C change over time. RESULTS: At baseline, the median (interquartile range [IQR]) LDL-C level was 3.44 (2.73-4.15) mmol/L in the evolocumab cohort (n = 395) and 2.20 (1.72-2.92) mmol/L in the stable statin cohort (n = 4160). At follow-up, the mean (95% confidence interval [CI]) percentage reduction in LDL-C levels was 63.0% (60.5-65.5%) in the evolocumab cohort and 2.5% (0.3-4.7%) in the stable statin cohort. CONCLUSIONS: LDL-C reductions in patients who added evolocumab to statin therapy in real-world clinical practice in China align with reductions observed in clinical trials.

摘要

引言:临床试验表明,在他汀类药物治疗基础上加用依洛尤单抗可使低密度脂蛋白胆固醇(LDL-C)水平降低约60%。鉴于试验环境与现实世界环境中患者特征和医疗标准存在差异,我们开展了一项队列研究,以评估在中国临床实践中使用依洛尤单抗降低LDL-C的效果。 方法:数据来源为天津地区医疗数据库(TRHD),该数据库包含为天津市区超过1500万居民提供服务的公立医院的关联电子健康记录(EHR)。研究队列包括2019年至2023年间在他汀类药物治疗基础上加用依洛尤单抗的成年动脉粥样硬化性心血管疾病(ASCVD)患者。关键纳入标准为在开始使用依洛尤单抗前后使用相同强度的他汀类药物,以及在基线(开始前90天内)和随访(开始后15 - 90天)时有可用的LDL-C值。采用描述性统计分析基线和随访之间LDL-C的变化。为了提供使用依洛尤单抗的背景信息以及评估研究方法,我们纳入了另一组他汀类药物强度稳定(至少180天未改变)的患者队列——这是一个随着时间推移LDL-C变化临床预期极小的队列。 结果:在基线时,依洛尤单抗队列(n = 395)的LDL-C水平中位数(四分位间距[IQR])为3.44(2.73 - 4.15)mmol/L,稳定他汀类药物队列(n = 4160)为2.20(1.72 - 2.92)mmol/L。在随访时,依洛尤单抗队列LDL-C水平的平均(95%置信区间[CI])降低百分比为63.0%(60.5 - 65.5%),稳定他汀类药物队列则为2.5%(0.3 - 4.7%)。 结论:在中国现实世界临床实践中,在他汀类药物治疗基础上加用依洛尤单抗的患者LDL-C降低情况与临床试验中观察到的降低情况一致。

相似文献

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

Adv Ther. 2025-6

[2]
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JAMA Cardiol. 2019-1-1

[3]
A retrospective nationwide analysis of evolocumab use in Sweden and its effect on low-density lipoprotein cholesterol levels.

Ups J Med Sci. 2024

[4]
Effectiveness, Adherence, and Safety of Evolocumab in a Swiss Multicenter Prospective Observational Study.

Adv Ther. 2022-1

[5]
Clinical Efficacy and Safety of Evolocumab in High-Risk Patients Receiving a Statin: Secondary Analysis of Patients With Low LDL Cholesterol Levels and in Those Already Receiving a Maximal-Potency Statin in a Randomized Clinical Trial.

JAMA Cardiol. 2017-12-1

[6]
Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease.

N Engl J Med. 2017-3-17

[7]
Low-density lipoprotein cholesterol lowering in real-world patients treated with evolocumab.

Clin Cardiol. 2021-5

[8]
Evolocumab in HIV-Infected Patients With Dyslipidemia: Primary Results of the Randomized, Double-Blind BEIJERINCK Study.

J Am Coll Cardiol. 2020-5-26

[9]
Simulation of Lipid-Lowering Therapy Intensification in a Population With Atherosclerotic Cardiovascular Disease.

JAMA Cardiol. 2017-9-1

[10]
Evolocumab for Early Reduction of LDL Cholesterol Levels in Patients With Acute Coronary Syndromes (EVOPACS).

J Am Coll Cardiol. 2019-8-31

本文引用的文献

[1]
Asia-Pacific Real-World Evolocumab Use, LDL-C Reduction, Physician Goals, and Patient Perceptions: HALES Observational Study.

Cardiol Ther. 2024-12

[2]
Comorbidities among adult patients with psoriasis in Tianjin: a cross-sectional analysis of the Health Database study.

BMJ Open. 2024-5-21

[3]
Comparison of clinical characteristics and disease burden between early- and late-onset type 2 diabetes patients: a population-based cohort study.

BMC Public Health. 2023-12-4

[4]
Real-World Insights into Evolocumab Use in Patients with Hyperlipidemia Across Five Countries: Analysis from the ZERBINI Study.

Cardiol Ther. 2023-12

[5]
2023 Chinese guideline for lipid management.

Front Pharmacol. 2023-8-29

[6]
Evolocumab effectiveness in the real-world setting: Austrian data from the pan-European observational HEYMANS study.

Wien Klin Wochenschr. 2024-2

[7]
Evolocumab Application in Real World From a Single-Center Registry in China.

Am J Ther. 2023-5-1

[8]
Evolving Management of Low-Density Lipoprotein Cholesterol: A Personalized Approach to Preventing Atherosclerotic Cardiovascular Disease Across the Risk Continuum.

J Am Heart Assoc. 2023-6-6

[9]
Lipid lowering effects and safety of evolocumab in Chinese patients at very high cardiovascular risk: a single-center study.

Chin Med J (Engl). 2023-6-5

[10]
PCSK9 inhibitors and reduction in cardiovascular events: Current evidence and future perspectives.

Kardiol Pol. 2023

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