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他汀类药物对肾衰竭患者的长期益处及安全性:一项目标试验模拟研究

Long-Term Benefits and Safety of Statins in Patients with Kidney Failure: A Target Trial Emulation Study.

作者信息

Cheng Franco Wing Tak, Xu Wanchun, Tang Sydney Chi Wai, Wan Eric Yuk Fai

机构信息

Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.

Pharmacy Department, Gleneagles Hong Kong Hospital, Hong Kong SAR, China.

出版信息

J Am Soc Nephrol. 2025 May 1;36(5):882-889. doi: 10.1681/ASN.0000000554. Epub 2024 Oct 31.

Abstract

KEY POINTS

Patients with kidney failure are at a higher risk of cardiovascular diseases, but the evidence for statin therapy remains inconclusive. The long-term benefits and risks of statin therapy in patients with kidney failure were analyzed using public electronic health records in Hong Kong. Statin therapy was associated with a lower risk of major cardiovascular diseases and all-cause mortality without a higher risk of major adverse events.

BACKGROUND

Patients with kidney failure are at elevated risk of cardiovascular diseases. Although statins are commonly used to mitigate cardiovascular risk among the population with high risk, the evidence for initiating statin therapy among patients with kidney failure remains inconclusive. This study aimed to investigate the long-term benefits and risks associated with statin therapy in patients with kidney failure.

METHODS

Using territory-wide public electronic health records in Hong Kong, 3019 statin-eligible individuals with kidney failure and elevated LDL cholesterol ≥100 mg/dl from January 2008 to December 2015 were included for analysis. The framework of target trial emulation was adopted to investigate the risk of the major cardiovascular diseases (., a composite of myocardial infarction, heart failure, and stroke), all-cause mortality, and major adverse events (., myopathies and liver dysfunction) between statin initiators and statin noninitiators. The pooled logistic model was used to obtain the hazard ratio for the outcomes of interest in both intention-to-treat (ITT) analysis and per-protocol (PP) analysis.

RESULTS

Significant risk reduction associated with statin therapy (hazard ratio [95% confidence interval]) was observed for major cardiovascular diseases (ITT: 0.78 [0.62 to 0.98]; PP: 0.66 [0.50 to 0.87]) and all-cause mortality (ITT: 0.80 [0.68 to 0.95]; PP: 0.60 [0.48 to 0.76]). The standardized 5- and 10-year absolute risk reduction in PP analysis was 7% (3% to 11%) and 11% (4% to 18%), respectively. No significant risks for the major adverse events were observed.

CONCLUSIONS

Statin therapy was associated with lower risks of cardiovascular diseases and all-cause mortality in patients with kidney failure without a higher risk of major adverse events.

摘要

要点

肾衰竭患者患心血管疾病的风险更高,但他汀类药物治疗的证据仍不确凿。利用香港的公共电子健康记录分析了他汀类药物治疗对肾衰竭患者的长期益处和风险。他汀类药物治疗与主要心血管疾病风险降低及全因死亡率降低相关,且主要不良事件风险未增加。

背景

肾衰竭患者患心血管疾病的风险升高。尽管他汀类药物常用于降低高危人群的心血管风险,但在肾衰竭患者中启动他汀类药物治疗的证据仍不确凿。本研究旨在调查他汀类药物治疗对肾衰竭患者的长期益处和风险。

方法

利用香港全地区的公共电子健康记录,纳入2008年1月至2015年12月期间3019名符合他汀类药物治疗条件、患有肾衰竭且低密度脂蛋白胆固醇≥100mg/dl的个体进行分析。采用目标试验模拟框架,调查他汀类药物启动者和未启动者之间主要心血管疾病(即心肌梗死、心力衰竭和中风的综合)、全因死亡率及主要不良事件(即肌病和肝功能障碍)的风险。采用汇总逻辑模型在意向性分析(ITT)和符合方案分析(PP)中获取感兴趣结局的风险比。

结果

观察到他汀类药物治疗与主要心血管疾病(ITT:0.78[0.62至0.98];PP:0.66[0.50至0.87])和全因死亡率(ITT:0.80[0.68至0.95];PP:0.60[0.48至0.76])显著降低相关。PP分析中标准化的5年和10年绝对风险降低分别为7%(3%至11%)和11%(4%至18%)。未观察到主要不良事件的显著风险。

结论

他汀类药物治疗与肾衰竭患者心血管疾病和全因死亡率风险降低相关,且主要不良事件风险未增加。

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