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Introduction <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> Methods <p>The data source was the Tianjin Regional Healthcare Database (TRHD), which includes linked electronic health records (EHR) of public hospitals serving over 15&#xa0;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&#xa0;days before initiation) and follow-up (15–90&#xa0;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&#xa0;days)—a cohort with minimal clinical expectation of further LDL-C change over time.</p> Results <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&#xa0;[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> Conclusions <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>

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

  • 期刊论文

  • 发表日期：

    2025年4月25日

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  • 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

摘要

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.