{"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":3.2000,"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\":3.2000,\"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}
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.
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.
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