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SGLT2 抑制剂与 2 型糖尿病或心力衰竭患者心律失常和心源性猝死的关系:34 项随机对照试验的荟萃分析。

Association of SGLT2 inhibitors with arrhythmias and sudden cardiac death in patients with type 2 diabetes or heart failure: A meta-analysis of 34 randomized controlled trials.

机构信息

Division of Cardiology, University of Miami Miller School of Medicine, Miami, Florida.

Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida.

出版信息

Heart Rhythm. 2021 Jul;18(7):1098-1105. doi: 10.1016/j.hrthm.2021.03.028. Epub 2021 Mar 20.

DOI:10.1016/j.hrthm.2021.03.028
PMID:33757845
Abstract

BACKGROUND

Sodium-glucose cotransporter 2 inhibitors (SGLT2is) reduce hospitalizations and death from heart failure (HF), but their effect on arrhythmia expression has been poorly investigated.

OBJECTIVE

The purpose of this study was to evaluate the association of SGLT2is with arrhythmias in patients with type 2 diabetes mellitus (T2DM) or HF.

METHODS

We searched PubMed and ClinicalTrials.gov. Two independent investigators identified randomized double-blind trials that compared SGLT2is with placebo or active control for adults with T2DM or HF. Primary outcomes were incident atrial arrhythmias, ventricular arrhythmias (VAs), and sudden cardiac death (SCD).

RESULTS

We included 34 randomized (25 placebo-controlled and 9 active-controlled) trials with 63,166 patients (35,883 SGLT2is vs 27,273 control: mean age 53-67 years; 63% male). Medications included canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin. Except for 1 study of HF, all patients had T2DM. Follow-up ranged from 24 weeks to 5.7 years. The cumulative incidence of events was low: 3.6, 1.4, and 2.5 per 1000 patient-years for atrial arrhythmias, VAs and SCD, respectively. SGLT2i therapy was associated with a significant reduction in the risk of incident atrial arrhythmias (odds ratio 0.81; 95% confidence interval 0.69-0.95; P = .008) and the "SCD" component of the SCD outcome (odds ratio 0.72; 95% confidence interval 0.54-0.97; P = .03) compared with control. There was no significant difference in incident VA or the "cardiac arrest" SCD component between groups.

CONCLUSION

SGLT2is are associated with significantly reduced risks of incident atrial arrhythmias and SCD in patients with T2DM. Prospective trials are warranted to confirm the antiarrhythmic effect of SGLT2is and whether this is a class or drug-specific effect.

摘要

背景

钠-葡萄糖协同转运蛋白 2 抑制剂(SGLT2is)可降低心力衰竭(HF)的住院率和死亡率,但对心律失常表现的影响研究甚少。

目的

本研究旨在评估 SGLT2is 在 2 型糖尿病(T2DM)或 HF 患者中的心律失常相关性。

方法

我们检索了 PubMed 和 ClinicalTrials.gov。两位独立的调查员确定了比较 SGLT2is 与安慰剂或活性对照治疗 T2DM 或 HF 成人的随机双盲试验。主要结局为新发心房性心律失常、室性心律失常(VA)和心源性猝死(SCD)。

结果

我们纳入了 34 项随机(25 项安慰剂对照和 9 项活性对照)试验,共 63166 名患者(35883 名 SGLT2is 与 27273 名对照:平均年龄 53-67 岁;63%为男性)。所用药物包括卡格列净、达格列净、恩格列净或埃格列净。除了 1 项 HF 研究外,所有患者均患有 T2DM。随访时间从 24 周至 5.7 年不等。事件累计发生率较低:心房性心律失常、VA 和 SCD 分别为每 1000 患者年 3.6、1.4 和 2.5 例。SGLT2i 治疗与新发心房性心律失常风险显著降低相关(比值比 0.81;95%置信区间 0.69-0.95;P =.008),以及 SCD 结局的“SCD”组成部分(比值比 0.72;95%置信区间 0.54-0.97;P =.03)与对照组相比。两组间新发 VA 或“SCD”组成部分的发生率无显著差异。

结论

SGLT2is 与 T2DM 患者新发心房性心律失常和 SCD 风险显著降低相关。需要前瞻性试验来证实 SGLT2is 的抗心律失常作用以及这是否是一种药物类别或药物特异性作用。

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