Zhou Shiyu, Chen Ruixuan, Liu Jiao, Guo Zhixin, Su Licong, Li Yanqin, Zhang Xiaodong, Luo Fan, Gao Qi, Lin Yuxin, Pang Mingzhen, Cao Lisha, Xu Xin, Nie Sheng
Division of Nephrology, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China (S.Z., R.C., J.L., Z.G., L.S., Y.Li, X.Z., F.L., Q.G., Y.Lin, M.P., L.C., X.X., S.N.).
Ann Intern Med. 2024 Dec;177(12):1641-1651. doi: 10.7326/M24-0178. Epub 2024 Oct 29.
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.
To compare the real-world effectiveness and safety of rosuvastatin and atorvastatin.
Active comparator cohort study using target trial emulation.
The China Renal Data System (CRDS) and UK Biobank (UKB) databases.
Adults newly prescribed rosuvastatin or atorvastatin.
The primary outcome was all-cause mortality. Cox proportional hazards regressions were used after 1:1 multilevel propensity score matching.
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.
Possible residual confounding.
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.
National Key R&D Program of China and National Natural Science Foundation of China.
瑞舒伐他汀和阿托伐他汀是处方最广泛的中高强度他汀类药物。然而，关于它们在实际使用中的疗效和安全性的证据有限。
比较瑞舒伐他汀和阿托伐他汀在现实世界中的有效性和安全性。
采用目标试验模拟的活性对照队列研究。
中国肾脏数据系统（CRDS）和英国生物银行（UKB）数据库。
新处方瑞舒伐他汀或阿托伐他汀的成年人。
主要结局为全因死亡率。在1:1多水平倾向评分匹配后使用Cox比例风险回归。
在两个数据库的285680名符合条件的参与者中，瑞舒伐他汀的6年全因死亡率低于阿托伐他汀（CRDS数据库中每100人年分别为2.57和2.83，UKB数据库中每100人年分别为0.66和0.90），CRDS数据库中累积发病率差异为-1.03%（95%CI，-1.44%至-0.46%），UKB数据库中为-1.38%（CI，-2.50%至-0.21%）。对于两个数据库中的次要结局，瑞舒伐他汀降低了主要不良心血管事件和主要肝脏不良结局的风险。在UKB数据库中，瑞舒伐他汀导致2型糖尿病发生风险更高，两种药物在慢性肾脏病和其他他汀类药物相关不良反应的发生风险方面相似。
可能存在残余混杂因素。
本研究发现与瑞舒伐他汀和阿托伐他汀相关的一些重要结局的风险存在差异。差异相对较小，许多未达到传统的统计学显著性标准。需要进一步研究以了解这些发现是否可在临床实践中放心使用。
国家重点研发计划和国家自然科学基金。
