中国临床实践中PCSK9i依从性与LDL降低和变异性之间关系的真实世界评估

IF 3.4 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
Clinical Epidemiology Pub Date : 2025-06-09 eCollection Date: 2025-01-01 DOI:10.2147/CLEP.S507761
Xiaomin Ye, Shaozhao Zhang, Xiangbin Zhong, Miaohong Li, Menghui Liu, Xiaodong Zhuang, Xinxue Liao
{"title":"中国临床实践中PCSK9i依从性与LDL降低和变异性之间关系的真实世界评估","authors":"Xiaomin Ye, Shaozhao Zhang, Xiangbin Zhong, Miaohong Li, Menghui Liu, Xiaodong Zhuang, Xinxue Liao","doi":"10.2147/CLEP.S507761","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Real-world evidence about adherence to proprotein convertase subtilisin/kexin type-9 inhibition (PCSK9i) is needed in Chinese population.</p><p><strong>Objective: </strong>We aimed to evaluate the adherence patterns using anti-PCSK9 monoclonal antibody in Chinese clinical practice and explored the association between adherence to PCSK9i and low-density lipoprotein cholesterol (LDL-C) reduction ratio and variability.</p><p><strong>Methods: </strong>A total of 5373 patients initiating PCSK9i in the First Affiliated Hospital of Sun Yat-sen University were included as sub-analysis of the RED-CARPET registry. Adherence to PCSK9i was measured by proportion of days covered (PDC), calculated for treatment covered days divided by 365 days during a one-year period. Reduction ratio (percentage points, range 0-100) was calculated as the ratio of reduction degree (difference between baseline value and the lowest value) to the baseline value. LDL-C variability was measured as standard deviation of three LDL-C measurement 2 weeks after medication initiation. We used linear regression to measure the association between PCSK9i PDC and the reduction ratio and variability of LDL-C. PDC (range 0-1) was scaled by 10 in the model.</p><p><strong>Results: </strong>At 12 months, the mean PDC was 0.09 ± 0.10. PCSK9i PDC was positively associated with LDL-C reduction ratio after adjustment for traditional risk factors (Adjusted β 4.05, 95% CI [2.61, 5.50]), p<0.001), which means for every 0.1-unit increase in PDC, the LDL-C reduction ratio increases by 4.05 percentage points. PCSK9i PDC was negatively associated with LDL-C standard deviation after fully adjustment (Adjusted β -0.042, 95% CI [-0.066, -0.018]), p=0.001). For every 0.1-unit increase in PDC, the LDL-C standard deviation decreased by 0.042 units, indicating improved lipid stability with higher adherence.</p><p><strong>Conclusion: </strong>The adherence to PCSK9i presented as a skewed distribution, most people only received one injection, which did not reach the ideal adherence goal. Unsatisfactory adherence to PCSK9i reduce the lipid-lowering effect of PCSK9i.</p>","PeriodicalId":10362,"journal":{"name":"Clinical Epidemiology","volume":"17 ","pages":"537-546"},"PeriodicalIF":3.4000,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12164899/pdf/","citationCount":"0","resultStr":"{\"title\":\"Real-World Assessment of the Association Between PCSK9i Adherence and LDL Reduction and Variability in a Chinese Clinical Practice.\",\"authors\":\"Xiaomin Ye, Shaozhao Zhang, Xiangbin Zhong, Miaohong Li, Menghui Liu, Xiaodong Zhuang, Xinxue Liao\",\"doi\":\"10.2147/CLEP.S507761\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Real-world evidence about adherence to proprotein convertase subtilisin/kexin type-9 inhibition (PCSK9i) is needed in Chinese population.</p><p><strong>Objective: </strong>We aimed to evaluate the adherence patterns using anti-PCSK9 monoclonal antibody in Chinese clinical practice and explored the association between adherence to PCSK9i and low-density lipoprotein cholesterol (LDL-C) reduction ratio and variability.</p><p><strong>Methods: </strong>A total of 5373 patients initiating PCSK9i in the First Affiliated Hospital of Sun Yat-sen University were included as sub-analysis of the RED-CARPET registry. Adherence to PCSK9i was measured by proportion of days covered (PDC), calculated for treatment covered days divided by 365 days during a one-year period. Reduction ratio (percentage points, range 0-100) was calculated as the ratio of reduction degree (difference between baseline value and the lowest value) to the baseline value. LDL-C variability was measured as standard deviation of three LDL-C measurement 2 weeks after medication initiation. We used linear regression to measure the association between PCSK9i PDC and the reduction ratio and variability of LDL-C. PDC (range 0-1) was scaled by 10 in the model.</p><p><strong>Results: </strong>At 12 months, the mean PDC was 0.09 ± 0.10. PCSK9i PDC was positively associated with LDL-C reduction ratio after adjustment for traditional risk factors (Adjusted β 4.05, 95% CI [2.61, 5.50]), p<0.001), which means for every 0.1-unit increase in PDC, the LDL-C reduction ratio increases by 4.05 percentage points. PCSK9i PDC was negatively associated with LDL-C standard deviation after fully adjustment (Adjusted β -0.042, 95% CI [-0.066, -0.018]), p=0.001). For every 0.1-unit increase in PDC, the LDL-C standard deviation decreased by 0.042 units, indicating improved lipid stability with higher adherence.</p><p><strong>Conclusion: </strong>The adherence to PCSK9i presented as a skewed distribution, most people only received one injection, which did not reach the ideal adherence goal. Unsatisfactory adherence to PCSK9i reduce the lipid-lowering effect of PCSK9i.</p>\",\"PeriodicalId\":10362,\"journal\":{\"name\":\"Clinical Epidemiology\",\"volume\":\"17 \",\"pages\":\"537-546\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-06-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12164899/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Epidemiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2147/CLEP.S507761\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Epidemiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/CLEP.S507761","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
引用次数: 0

摘要

背景:需要真实世界的证据来证明中国人群对蛋白转化酶枯草杆菌素/克辛蛋白9型抑制(PCSK9i)的依从性。目的:评价中国临床应用抗pcsk9单克隆抗体的依从性模式,探讨PCSK9i依从性与低密度脂蛋白胆固醇(LDL-C)降低率和变异性的关系。方法:选取中山大学第一附属医院5373例启动PCSK9i的患者作为RED-CARPET登记的亚分析。对PCSK9i的依从性通过覆盖天数的比例(PDC)来衡量,PDC计算的是治疗覆盖天数除以一年期间的365天。还原率(百分比,范围0-100)计算为还原度(基线值与最低值之差)与基线值之比。LDL-C变异性以开始用药2周后3次LDL-C测量的标准差来测量。我们使用线性回归来测量PCSK9i PDC与LDL-C降低率和变异性之间的关系。模型中PDC(范围0-1)按10进行缩放。结果:12个月时,平均PDC为0.09±0.10。经传统危险因素校正后,PCSK9i PDC与LDL-C降低率呈正相关(Adjusted β 4.05, 95% CI[2.61, 5.50])。结论:PCSK9i的依从性呈偏态分布,大部分患者只注射一次,未达到理想的依从性目标。对PCSK9i的依从性不理想会降低PCSK9i的降脂作用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Real-World Assessment of the Association Between PCSK9i Adherence and LDL Reduction and Variability in a Chinese Clinical Practice.

Background: Real-world evidence about adherence to proprotein convertase subtilisin/kexin type-9 inhibition (PCSK9i) is needed in Chinese population.

Objective: We aimed to evaluate the adherence patterns using anti-PCSK9 monoclonal antibody in Chinese clinical practice and explored the association between adherence to PCSK9i and low-density lipoprotein cholesterol (LDL-C) reduction ratio and variability.

Methods: A total of 5373 patients initiating PCSK9i in the First Affiliated Hospital of Sun Yat-sen University were included as sub-analysis of the RED-CARPET registry. Adherence to PCSK9i was measured by proportion of days covered (PDC), calculated for treatment covered days divided by 365 days during a one-year period. Reduction ratio (percentage points, range 0-100) was calculated as the ratio of reduction degree (difference between baseline value and the lowest value) to the baseline value. LDL-C variability was measured as standard deviation of three LDL-C measurement 2 weeks after medication initiation. We used linear regression to measure the association between PCSK9i PDC and the reduction ratio and variability of LDL-C. PDC (range 0-1) was scaled by 10 in the model.

Results: At 12 months, the mean PDC was 0.09 ± 0.10. PCSK9i PDC was positively associated with LDL-C reduction ratio after adjustment for traditional risk factors (Adjusted β 4.05, 95% CI [2.61, 5.50]), p<0.001), which means for every 0.1-unit increase in PDC, the LDL-C reduction ratio increases by 4.05 percentage points. PCSK9i PDC was negatively associated with LDL-C standard deviation after fully adjustment (Adjusted β -0.042, 95% CI [-0.066, -0.018]), p=0.001). For every 0.1-unit increase in PDC, the LDL-C standard deviation decreased by 0.042 units, indicating improved lipid stability with higher adherence.

Conclusion: The adherence to PCSK9i presented as a skewed distribution, most people only received one injection, which did not reach the ideal adherence goal. Unsatisfactory adherence to PCSK9i reduce the lipid-lowering effect of PCSK9i.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Clinical Epidemiology
Clinical Epidemiology Medicine-Epidemiology
CiteScore
6.30
自引率
5.10%
发文量
169
审稿时长
16 weeks
期刊介绍: Clinical Epidemiology is an international, peer reviewed, open access journal. Clinical Epidemiology focuses on the application of epidemiological principles and questions relating to patients and clinical care in terms of prevention, diagnosis, prognosis, and treatment. Clinical Epidemiology welcomes papers covering these topics in form of original research and systematic reviews. Clinical Epidemiology has a special interest in international electronic medical patient records and other routine health care data, especially as applied to safety of medical interventions, clinical utility of diagnostic procedures, understanding short- and long-term clinical course of diseases, clinical epidemiological and biostatistical methods, and systematic reviews. When considering submission of a paper utilizing publicly-available data, authors should ensure that such studies add significantly to the body of knowledge and that they use appropriate validated methods for identifying health outcomes. The journal has launched special series describing existing data sources for clinical epidemiology, international health care systems and validation studies of algorithms based on databases and registries.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信