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
{"title":"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","authors":"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","doi":"10.1007/s12325-025-03199-3","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>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.</p><h3>Methods</h3><p>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.</p><h3>Results</h3><p>At baseline, the median (interquartile range [IQR]) LDL-C level was 3.44 (2.73–4.15) mmol/L in the evolocumab cohort (<i>n</i> = 395) and 2.20 (1.72–2.92) mmol/L in the stable statin cohort (<i>n</i> = 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.</p><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 6","pages":"2874 - 2887"},"PeriodicalIF":3.4000,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"LDL-C Reduction with Evolocumab Among Patients with ASCVD in China: Real-World Evidence from Tianjin Metropolitan Area\",\"authors\":\"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\",\"doi\":\"10.1007/s12325-025-03199-3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>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.</p><h3>Methods</h3><p>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.</p><h3>Results</h3><p>At baseline, the median (interquartile range [IQR]) LDL-C level was 3.44 (2.73–4.15) mmol/L in the evolocumab cohort (<i>n</i> = 395) and 2.20 (1.72–2.92) mmol/L in the stable statin cohort (<i>n</i> = 4160). 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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.
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.