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
School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, Jiangsu, China.
Center for Observational Research, Amgen China, Shanghai, China.
Adv Ther. 2025 Jun;42(6):2874-2887. doi: 10.1007/s12325-025-03199-3. Epub 2025 Apr 25.
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.
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。
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