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钠-葡萄糖共转运蛋白 2 抑制剂在住院患者中的安全性和疗效的系统评价和荟萃分析

A Systematic Review and Meta-analysis on the Safety and Efficacy of Sodium-Glucose Cotransporter 2 Inhibitor Use in Hospitalized Patients.

机构信息

Department of Endocrinology, Austin Hospital, Melbourne, Australia.

Department of Medicine, Austin Health, Melbourne Medical School, The University of Melbourne, Melbourne, Australia.

出版信息

Diabetes Care. 2024 Dec 1;47(12):2275-2290. doi: 10.2337/dc24-0946.

Abstract

BACKGROUND

The safety and efficacy of sodium-glucose cotransporter 2 (SGLT2) inhibitors in hospitalized patients are unclear.

PURPOSE

To evaluate outcomes of inpatient SGLT2 inhibitor use.

DATA SOURCES

MEDLINE, Embase, Emcare, and Cochrane databases were searched through 29 May 2024.

STUDY SELECTION

Randomized controlled trials (RCTs) and observational cohort studies with assessment of SGLT2 inhibitor use in patients hospitalized for any reason were included.

DATA EXTRACTION

Study characteristics and clinical outcomes were extracted.

DATA SYNTHESIS

We performed a random-effects meta-analysis analyzing RCTs and cohort studies separately. Heterogeneity was quantified with the I2 statistic. Twenty-three RCTs comprising 19,846 participants (29.5% with type 2 diabetes) with comparison of SGLT2 inhibitors with placebo or active comparator were included. Ketoacidosis rates were 0.210 per 100 person-years (95% CI 0.119, 0.370) for SGLT2 inhibitors and 0.140 per 100 person-years (95% CI 0.070, 0.280) for control (rate ratio 1.50 [95 CI 0.56, 4.23], P = 0.38). SGLT2 inhibitor use was associated with fewer readmissions and urgent visits (odds ratio [OR] 0.64 [95 CI 0.47, 0.86], P < 0.01) and lower mortality rates (OR 0.74 [95% CI 0.56, 0.98], P = 0.03) in heart failure trials and lower incidence of acute kidney injury (OR 0.76 [95% CI 0.60, 0.97], P = 0.03) among all RCTs. Twenty observational studies were included and did not show increased adverse events.

LIMITATIONS

Ketoacidosis rates were low, likely leading to lack of power to detect significant differences.

CONCLUSIONS

SGLT2 inhibitor use among hospitalized patients was associated with numerically higher rates of ketoacidosis, although further studies are required.

摘要

背景

钠-葡萄糖共转运蛋白 2(SGLT2)抑制剂在住院患者中的安全性和疗效尚不清楚。

目的

评估住院患者使用 SGLT2 抑制剂的结局。

数据来源

通过 2024 年 5 月 29 日检索 MEDLINE、Embase、Emcare 和 Cochrane 数据库。

研究选择

纳入评估任何原因住院患者 SGLT2 抑制剂使用情况的随机对照试验(RCT)和观察性队列研究。

数据提取

提取研究特征和临床结局。

数据综合

我们分别对 RCT 和队列研究进行了随机效应荟萃分析。使用 I2 统计量量化异质性。纳入 23 项 RCT,共纳入 19846 名参与者(29.5%患有 2 型糖尿病),比较 SGLT2 抑制剂与安慰剂或活性对照药物的疗效。SGLT2 抑制剂组酮症酸中毒发生率为每 100 人年 0.210(95%CI 0.119,0.370),对照组为每 100 人年 0.140(95%CI 0.070,0.280)(发生率比 1.50[95%CI 0.56,4.23],P = 0.38)。SGLT2 抑制剂的使用与再入院和急诊就诊次数减少(比值比 [OR] 0.64[95%CI 0.47,0.86],P <0.01)和心力衰竭试验中的死亡率降低(OR 0.74[95%CI 0.56,0.98],P = 0.03)相关,所有 RCT 中 SGLT2 抑制剂的使用与急性肾损伤发生率降低相关(OR 0.76[95%CI 0.60,0.97],P = 0.03)。纳入 20 项观察性研究,未发现不良事件增加。

局限性

酮症酸中毒发生率较低,可能导致缺乏检测差异的能力。

结论

住院患者使用 SGLT2 抑制剂与酮症酸中毒发生率略有增加相关,但还需要进一步研究。

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