Evolocumab在中国ASCVD患者中降低LDL-C:来自天津大都市区的真实世界证据

IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
Liming Zhao, Jiamei Liu, Yin Liu, Zhenna Huang, Xuxiao Ye, Jeff L. Lange, Nafeesa Dhalwani, Fan Yang, Zizhao Zhang, Kangyin Chen, Hao Zhang, Jifang Zhou
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引用次数: 0

摘要

临床试验表明,在他汀类药物治疗中加入evolocumab可使低密度脂蛋白胆固醇(LDL-C)水平降低约60%。鉴于试验和现实环境中患者特征和护理标准的差异,我们进行了一项队列研究,以评估evolocumab在中国临床实践中降低LDL-C的效果。方法:数据来源为天津市区域卫生数据库(TRHD),该数据库包括天津市区1500多万居民的公立医院的电子健康记录(EHR)。该研究队列包括患有动脉粥样硬化性心血管疾病(ASCVD)的成年患者,他们在2019年至2023年期间在他汀类药物治疗中添加了evolocumab。主要纳入标准是evolocumab起始前后使用相同的他汀类药物强度,基线(起始前90天内)和随访(起始后15-90天)时可用LDL-C值。采用描述性统计分析基线和随访期间LDL-C的变化。为了提供evolocumab使用和研究方法评估的背景,我们纳入了另一组他汀类药物强度稳定(至少180天不变)的患者,这是一组临床预期LDL-C随时间进一步变化最小的患者。结果:基线时,evolocumab组(n = 395)的中位(四分位间距[IQR]) LDL-C水平为3.44 (2.73-4.15)mmol/L,稳定他汀组(n = 4160)的中位(四分位间距[IQR]) LDL-C水平为2.20 (1.72-2.92)mmol/L。在随访中,evolocumab组LDL-C水平的平均(95%置信区间[CI])下降百分比为63.0%(60.5-65.5%),稳定的他汀类药物组为2.5%(0.3-4.7%)。结论:在中国现实世界的临床实践中,在他汀类药物治疗中加入evolocumab的患者LDL-C降低与临床试验中观察到的降低一致。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
LDL-C Reduction with Evolocumab Among Patients with ASCVD in China: Real-World Evidence from Tianjin Metropolitan Area

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.

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来源期刊
Advances in Therapy
Advances in Therapy 医学-药学
CiteScore
7.20
自引率
2.60%
发文量
353
审稿时长
6-12 weeks
期刊介绍: Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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