Shiyu Zhou, Ruixuan Chen, Jiao Liu, Zhixin Guo, Licong Su, Yanqin Li, Xiaodong Zhang, Fan Luo, Qi Gao, Yuxin Lin, Mingzhen Pang, Lisha Cao, Xin Xu, Sheng Nie
{"title":"阿托伐他汀与瑞舒伐他汀的有效性和安全性比较：一项多数据库队列研究。","authors":"Shiyu Zhou, Ruixuan Chen, Jiao Liu, Zhixin Guo, Licong Su, Yanqin Li, Xiaodong Zhang, Fan Luo, Qi Gao, Yuxin Lin, Mingzhen Pang, Lisha Cao, Xin Xu, Sheng Nie","doi":"10.7326/M24-0178","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Rosuvastatin and atorvastatin are the most widely prescribed moderate- to high-intensity statins. However, evidence on their efficacy and safety during actual use is limited.</p><p><strong>Objective: </strong>To compare the real-world effectiveness and safety of rosuvastatin and atorvastatin.</p><p><strong>Design: </strong>Active comparator cohort study using target trial emulation.</p><p><strong>Setting: </strong>The China Renal Data System (CRDS) and UK Biobank (UKB) databases.</p><p><strong>Participants: </strong>Adults newly prescribed rosuvastatin or atorvastatin.</p><p><strong>Measurements: </strong>The primary outcome was all-cause mortality. Cox proportional hazards regressions were used after 1:1 multilevel propensity score matching.</p><p><strong>Results: </strong>Among the 285 680 eligible participants in both databases, 6-year all-cause mortality was lower for rosuvastatin than for atorvastatin (2.57 vs. 2.83 per 100 person-years in the CRDS database and 0.66 vs. 0.90 per 100 person-years in the UKB database), with differences in cumulative incidence of -1.03% (95% CI, -1.44% to -0.46%) in the CRDS database and -1.38% (CI, -2.50% to -0.21%) in the UKB database. For secondary outcomes in both databases, rosuvastatin conferred lower risks for major adverse cardiovascular events and major adverse liver outcomes. In the UKB database, the risk for development of type 2 diabetes mellitus was higher with rosuvastatin, and the 2 medications carried similar risks for development of chronic kidney disease and other statin-related adverse effects.</p><p><strong>Limitation: </strong>Possible residual confounding.</p><p><strong>Conclusion: </strong>This study found differences in risks for some important outcomes associated with rosuvastatin and atorvastatin. The differences were relatively small, and many did not meet traditional standards for statistical significance. Further research is needed to understand whether these findings can be used with confidence in clinical practice.</p><p><strong>Primary funding source: </strong>National Key R&D Program of China and National Natural Science Foundation of China.</p>","PeriodicalId":7932,"journal":{"name":"Annals of Internal Medicine","volume":" ","pages":""},"PeriodicalIF":19.6000,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparative Effectiveness and Safety of Atorvastatin Versus Rosuvastatin : A Multi-database Cohort Study.\",\"authors\":\"Shiyu Zhou, Ruixuan Chen, Jiao Liu, Zhixin Guo, Licong Su, Yanqin Li, Xiaodong Zhang, Fan Luo, Qi Gao, Yuxin Lin, Mingzhen Pang, Lisha Cao, Xin Xu, Sheng Nie\",\"doi\":\"10.7326/M24-0178\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Rosuvastatin and atorvastatin are the most widely prescribed moderate- to high-intensity statins. However, evidence on their efficacy and safety during actual use is limited.</p><p><strong>Objective: </strong>To compare the real-world effectiveness and safety of rosuvastatin and atorvastatin.</p><p><strong>Design: </strong>Active comparator cohort study using target trial emulation.</p><p><strong>Setting: </strong>The China Renal Data System (CRDS) and UK Biobank (UKB) databases.</p><p><strong>Participants: </strong>Adults newly prescribed rosuvastatin or atorvastatin.</p><p><strong>Measurements: </strong>The primary outcome was all-cause mortality. Cox proportional hazards regressions were used after 1:1 multilevel propensity score matching.</p><p><strong>Results: </strong>Among the 285 680 eligible participants in both databases, 6-year all-cause mortality was lower for rosuvastatin than for atorvastatin (2.57 vs. 2.83 per 100 person-years in the CRDS database and 0.66 vs. 0.90 per 100 person-years in the UKB database), with differences in cumulative incidence of -1.03% (95% CI, -1.44% to -0.46%) in the CRDS database and -1.38% (CI, -2.50% to -0.21%) in the UKB database. For secondary outcomes in both databases, rosuvastatin conferred lower risks for major adverse cardiovascular events and major adverse liver outcomes. In the UKB database, the risk for development of type 2 diabetes mellitus was higher with rosuvastatin, and the 2 medications carried similar risks for development of chronic kidney disease and other statin-related adverse effects.</p><p><strong>Limitation: </strong>Possible residual confounding.</p><p><strong>Conclusion: </strong>This study found differences in risks for some important outcomes associated with rosuvastatin and atorvastatin. The differences were relatively small, and many did not meet traditional standards for statistical significance. Further research is needed to understand whether these findings can be used with confidence in clinical practice.</p><p><strong>Primary funding source: </strong>National Key R&D Program of China and National Natural Science Foundation of China.</p>\",\"PeriodicalId\":7932,\"journal\":{\"name\":\"Annals of Internal Medicine\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":19.6000,\"publicationDate\":\"2024-10-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of Internal Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.7326/M24-0178\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Internal Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.7326/M24-0178","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
摘要
背景：瑞舒伐他汀和阿托伐他汀是处方量最大的中高强度他汀类药物。然而，有关它们在实际使用过程中的有效性和安全性的证据却很有限：比较罗伐他汀和阿托伐他汀在现实世界中的有效性和安全性：设计：采用目标试验模拟法进行主动比较队列研究：中国肾脏数据系统（CRDS）和英国生物库（UKB）数据库：新处方罗伐他汀或阿托伐他汀的成人：主要结果为全因死亡率。在进行1:1多层次倾向评分匹配后，采用Cox比例危险度回归：在两个数据库的285 680名合格参与者中，罗伐他汀的6年全因死亡率低于阿托伐他汀（在CRDS数据库中为每100人年2.57例 vs. 2.83例，在UKB数据库中为每100人年0.66例 vs. 0.90例），在CRDS数据库中累计发生率的差异为-1.03% (95% CI, -1.44% to -0.46%)，在UKB数据库中累计发生率的差异为-1.38% (CI, -2.50% to -0.21%)。对于两个数据库中的次要结果，罗伐他汀可降低主要不良心血管事件和主要不良肝脏结果的风险。在UKB数据库中，罗伐他汀的2型糖尿病发病风险较高，两种药物的慢性肾脏病和其他他汀相关不良反应的发病风险相似：局限性：可能存在残余混杂因素：本研究发现，罗伐他汀和阿托伐他汀对某些重要结果的风险存在差异。这些差异相对较小，而且许多差异不符合传统的统计学意义标准。要想了解这些研究结果是否可以在临床实践中放心使用，还需要进一步的研究：国家重点研发计划和国家自然科学基金。
Comparative Effectiveness and Safety of Atorvastatin Versus Rosuvastatin : A Multi-database Cohort Study.
Background: Rosuvastatin and atorvastatin are the most widely prescribed moderate- to high-intensity statins. However, evidence on their efficacy and safety during actual use is limited.
Objective: To compare the real-world effectiveness and safety of rosuvastatin and atorvastatin.
Design: Active comparator cohort study using target trial emulation.
Setting: The China Renal Data System (CRDS) and UK Biobank (UKB) databases.
Participants: Adults newly prescribed rosuvastatin or atorvastatin.
Measurements: The primary outcome was all-cause mortality. Cox proportional hazards regressions were used after 1:1 multilevel propensity score matching.
Results: Among the 285 680 eligible participants in both databases, 6-year all-cause mortality was lower for rosuvastatin than for atorvastatin (2.57 vs. 2.83 per 100 person-years in the CRDS database and 0.66 vs. 0.90 per 100 person-years in the UKB database), with differences in cumulative incidence of -1.03% (95% CI, -1.44% to -0.46%) in the CRDS database and -1.38% (CI, -2.50% to -0.21%) in the UKB database. For secondary outcomes in both databases, rosuvastatin conferred lower risks for major adverse cardiovascular events and major adverse liver outcomes. In the UKB database, the risk for development of type 2 diabetes mellitus was higher with rosuvastatin, and the 2 medications carried similar risks for development of chronic kidney disease and other statin-related adverse effects.
Limitation: Possible residual confounding.
Conclusion: This study found differences in risks for some important outcomes associated with rosuvastatin and atorvastatin. The differences were relatively small, and many did not meet traditional standards for statistical significance. Further research is needed to understand whether these findings can be used with confidence in clinical practice.
Primary funding source: National Key R&D Program of China and National Natural Science Foundation of China.
期刊介绍：
Established in 1927 by the American College of Physicians (ACP), Annals of Internal Medicine is the premier internal medicine journal. Annals of Internal Medicine’s mission is to promote excellence in medicine, enable physicians and other health care professionals to be well informed members of the medical community and society, advance standards in the conduct and reporting of medical research, and contribute to improving the health of people worldwide. To achieve this mission, the journal publishes a wide variety of original research, review articles, practice guidelines, and commentary relevant to clinical practice, health care delivery, public health, health care policy, medical education, ethics, and research methodology. In addition, the journal publishes personal narratives that convey the feeling and the art of medicine.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
