使用 SGLT2 抑制剂与其他降血糖药物的 2 型糖尿病患者的急性肾损伤事件：一项回顾性队列研究。
Acute Kidney Injury Events in Patients With Type 2 Diabetes Using SGLT2 Inhibitors Versus Other Glucose-Lowering Drugs: A Retrospective Cohort Study.
机构信息
University of Manitoba, Rady Faculty of Health Sciences, Max Rady College of Medicine, Departments of Internal Medicine, Winnipeg, Canada.
University of Manitoba, Rady Faculty of Health Sciences, Max Rady College of Medicineand Endocrinology, Winnipeg, Canada.
出版信息
Am J Kidney Dis. 2020 Oct;76(4):471-479.e1. doi: 10.1053/j.ajkd.2020.03.019. Epub 2020 May 25.
RATIONALE & OBJECTIVE: Sodium/glucose cotransporter 2 (SGLT2) inhibitors slow the progression of chronic kidney disease and prevent heart failure events. However, SGLT2 inhibitors may increase the risk for acute kidney injury (AKI). Our objective was to assess whether SGLT2 inhibitor use, compared with all other glucose-lowering drugs (oGLDs), is associated with increased rates of AKI.
STUDY DESIGN
Retrospective cohort study.
SETTING & PARTICIPANTS: Adults in Manitoba, Canada, with type 2 diabetes mellitus followed up from June 2014 until March 2017.
EXPOSURES
Initial SGLT2 inhibitor or oGLD use ascertained through a province-wide outpatient prescription database.
OUTCOME
The primary outcome was incident AKI, identified either by an increase in serum creatinine level and/or hospital discharge codes for AKI while taking glucose-lowering drugs (on-treatment approach).
ANALYTICAL APPROACH
A propensity score analysis was used to assemble groups of incident users of SGLT2 inhibitors and a 1:1 matched set of oGLD users. The rate of AKI was compared across matched groups using cause-specific hazards models. Sensitivity analyses considered exposure to be constant throughout follow-up after initiation of the drug treatment (intention-to-treat approach) or incorporated recurrent exposures (new user design).
RESULTS
Comparing 4,778 incident users of SGLT2 inhibitors with 4,778 incident users of oGLDs, there were no differences observed in the primary outcome (HR, 0.64; 95% CI, 0.40-1.03; P = 0.06) using an on-treatment approach. In neither set of sensitivity analyses were SGLT2 inhibitors associated with increased risk for AKI.
LIMITATIONS
Drug choice may have been related to AKI risk, laboratory data were obtained from clinical care, and changes in adverse event reporting may have followed the US Food and Drug Administration warning. There were insufficient data to compare individual SGLT2 inhibitors.
CONCLUSIONS
Compared with oGLDs, SGLT2 inhibitors were not observed to be associated with increased risk for AKI in a clinical population-based cohort.
背景与目的
钠-葡萄糖共转运蛋白 2（SGLT2）抑制剂可减缓慢性肾脏病的进展并预防心力衰竭事件。然而，SGLT2 抑制剂可能会增加急性肾损伤（AKI）的风险。我们的目的是评估与所有其他降糖药物（oGLD）相比，SGLT2 抑制剂的使用是否与 AKI 发生率的增加相关。
研究设计
回顾性队列研究。
设置与参与者
加拿大马尼托巴省 2014 年 6 月至 2017 年 3 月期间随访的患有 2 型糖尿病的成年人。
暴露
通过全省门诊处方数据库确定初始 SGLT2 抑制剂或 oGLD 的使用情况。
结局
主要结局是 AKI 的发生，通过服用降糖药物时血清肌酐水平升高和/或 AKI 住院出院代码来确定（治疗方法）。
分析方法
使用倾向评分分析来组建 SGLT2 抑制剂新使用者和 oGLD 新使用者的匹配组。使用特定原因的风险模型比较匹配组之间 AKI 的发生率。敏感性分析考虑了药物治疗开始后整个随访期间的暴露情况（意向治疗方法）或纳入了复发性暴露（新用户设计）。
结果
与 4778 例 SGLT2 抑制剂新使用者和 4778 例 oGLD 新使用者相比，在治疗方法中，主要结局没有差异（HR，0.64；95%CI，0.40-1.03；P=0.06）。在敏感性分析中，SGLT2 抑制剂都未与 AKI 风险增加相关。
局限性
药物选择可能与 AKI 风险有关，实验室数据来自临床护理，不良事件报告的变化可能遵循美国食品和药物管理局的警告。没有足够的数据来比较个别 SGLT2 抑制剂。
结论
与 oGLD 相比，在临床人群队列中，SGLT2 抑制剂与 AKI 风险增加无关。
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