钠-葡萄糖共转运蛋白 2 抑制剂与 5 期慢性肾脏病患者透析和心血管疾病风险。
Sodium-Glucose Cotransporter-2 Inhibitors and the Risk for Dialysis and Cardiovascular Disease in Patients With Stage 5 Chronic Kidney Disease.
机构信息
Dr. Yen's Clinic, Taoyuan, Taiwan (F.-S.Y.).
Faculty of Medicine, National Yang Ming Chiao Tung University School of Medicine, and Section of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan (C.-M.H.).
出版信息
Ann Intern Med. 2024 Jun;177(6):693-700. doi: 10.7326/M23-1874. Epub 2024 Apr 30.
BACKGROUND
No studies have reported the long-term outcomes of initiating sodium-glucose cotransporter-2 inhibitors (SGLT2is) in patients with estimated glomerular filtration rates less than 20 mL/min/1.73 m to predialysis.
OBJECTIVE
To compare the risk for dialysis, cardiovascular events, and death between SGLT2i users and nonusers in patients with type 2 diabetes (T2D) and stage 5 chronic kidney disease (CKD).
DESIGN
Target trial emulation study.
SETTING
Taiwan's National Health Insurance Research Database (NHIRD).
PARTICIPANTS
By applying sequential target trial emulation principle, 23 854 SGLT2i users and 23 892 SGLT2i nonusers were selected from the NHIRD for patients with T2D and stage 5 CKD from 1 May 2016 to 31 October 2021.
MEASUREMENTS
Conditional Cox proportional hazards models were used to compare the risks for dialysis, hospitalization for heart failure, acute myocardial infarction (AMI), diabetic ketoacidosis (DKA), acute kidney injury (AKI), and all-cause mortality between SGLT2i users and nonusers.
RESULTS
In the intention-to-treat model, compared with no SGLT2i use, SGLT2i use was associated with lower risks for dialysis (hazard ratio [HR], 0.34 [95% CI, 0.27 to 0.43]), hospitalization for heart failure (HR, 0.80 [CI, 0.73 to 0.86]), AMI (HR, 0.61 [CI, 0.52 to 0.73]), DKA (HR, 0.78 [CI, 0.71 to 0.85]), and AKI (HR, 0.80 [CI, 0.70 to 0.90]), but there was no difference in the risk for all-cause mortality (HR, 1.11 [CI, 0.99 to 1.24]). The Kaplan-Meier curves and subgroup analyses also showed that initiation of an SGLT2i in stage 5 CKD was associated with a lower risk for long-term dialysis than no SGLT2i use.
LIMITATION
This result may not apply to patients without T2D.
CONCLUSION
This emulated target trial showed that SGLT2i use was associated with a lower risk for dialysis, cardiovascular events, DKA, and AKI than no SGLT2i use in patients with T2D and stage 5 CKD.
PRIMARY FUNDING SOURCE
National Health Research Institutes, Taiwan.
背景
尚无研究报告估算肾小球滤过率（eGFR）小于 20 mL/min/1.73 m 至透析前的患者开始使用钠-葡萄糖共转运蛋白 2 抑制剂（SGLT2i）的长期结局。
目的
比较 2 型糖尿病（T2D）和 5 期慢性肾脏病（CKD）患者中 SGLT2i 使用者与非使用者之间发生透析、心血管事件和死亡的风险。
设计
目标试验仿真研究。
设置
台湾全民健康保险研究数据库（NHIRD）。
参与者
通过应用序贯目标试验仿真原理，从 NHIRD 中选择 2016 年 5 月 1 日至 2021 年 10 月 31 日期间患有 T2D 和 5 期 CKD 的 23854 名 SGLT2i 使用者和 23892 名 SGLT2i 非使用者。
测量
条件 Cox 比例风险模型用于比较 SGLT2i 使用者与非使用者之间发生透析、心力衰竭住院、急性心肌梗死（AMI）、糖尿病酮症酸中毒（DKA）、急性肾损伤（AKI）和全因死亡率的风险。
结果
在意向治疗模型中，与未使用 SGLT2i 相比，使用 SGLT2i 与较低的透析风险相关（风险比 [HR]，0.34 [95%CI，0.27 至 0.43]）、心力衰竭住院（HR，0.80 [CI，0.73 至 0.86]）、AMI（HR，0.61 [CI，0.52 至 0.73]）、DKA（HR，0.78 [CI，0.71 至 0.85]）和 AKI（HR，0.80 [CI，0.70 至 0.90]），但全因死亡率风险无差异（HR，1.11 [CI，0.99 至 1.24]）。Kaplan-Meier 曲线和亚组分析也表明，在 5 期 CKD 中开始使用 SGLT2i 与降低长期透析风险相关，而非不使用 SGLT2i。
局限性
该结果可能不适用于没有 T2D 的患者。
结论
本仿真目标试验表明，在患有 T2D 和 5 期 CKD 的患者中，与不使用 SGLT2i 相比，使用 SGLT2i 与较低的透析、心血管事件、DKA 和 AKI 风险相关。
主要资金来源
台湾国家卫生研究院。
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