Investigating Sodium-Glucose Cotransporter 2 Inhibitors Versus Other Glucose-Lowering Drugs on Ventricular Arrhythmias or Sudden Cardiac Death Using the US FDA Adverse Event Reporting System.

IF 3.1 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Cardiovascular Drugs and Therapy Pub Date : 2024-12-04 DOI:10.1007/s10557-024-07653-2

Bo Xu, Tianqiao Zhang, Bo Kang, Xiongwen Yang, Shaoqian Li, Jixiang Chen, Zunbo He, Jiecan Zhou

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引用次数: 0

Abstract

Purpose: Sodium-glucose cotransporter 2 (SGLT2) inhibitors have been reported to exhibit antiarrhythmic effects. However, there is conflicting evidence regarding the association between SGLT2 inhibitors and ventricular arrhythmias or sudden cardiac death (SCD). We utilized the US FDA Adverse Event Reporting System (FAERS) database to investigate the reporting frequencies of SGLT2 inhibitors with ventricular arrhythmias and SCD compared to other glucose-lowering drugs (ATC-A10B).

Methods: We used the web data mining tool AERSMine to mine reports of ventricular arrhythmias and SCD from FAERS to compare SGLT2 inhibitors versus other glucose-lowering drugs. The mining range was from 2004q1 to 2023q3. Disproportionality analysis used the proportional reporting ratio (PRR) with 95% confidence interval (CI) and information component (IC) with 95% credible interval.

Results: From 2004q1 to 2023q3, a total of 121,129 adverse events were reported for SGLT2 inhibitors, with a total of 1,127,485 in the ATC-A10B group. Ventricular arrhythmias reporting frequency in the SGLT2 inhibitors group was similar to that of the control group (1.36/1000 reports vs 1.55/1000 reports; p = 0.10), with a PRR of 0.88 (95%CI 0.75-1.03). However, the reporting frequency of SCD in the SGLT2 inhibitors group was significantly lower than that of the control group (1.43 vs 4.70/1000; p < 0.001), with a PRR of 0.30 (95%CI 0.26-0.35), and this trend was observed within individual molecules of SGLT2 inhibitors. During the sensitivity analysis process, the results obtained when restricting the scope of data mining to between 2013q1 and 2023q3 were similar to those obtained when using data from 2004q1 to 2023q3.

Conclusion: In this drug pharmacovigilance assessment, the reporting frequency of ventricular arrhythmias associated with SGLT2 inhibitors was similar to that of other antidiabetic medications, while the reporting frequency of SCD related to SGLT2 inhibitors was lower. This real-world study evidence complements existing clinical evidence.

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使用美国FDA不良事件报告系统研究钠-葡萄糖共转运蛋白2抑制剂与其他降糖药物对室性心律失常或心源性猝死的影响

目的：钠-葡萄糖共转运蛋白2 （SGLT2）抑制剂已被报道具有抗心律失常作用。然而，关于SGLT2抑制剂与室性心律失常或心源性猝死（SCD）之间的关联，存在相互矛盾的证据。我们利用美国FDA不良事件报告系统（FAERS）数据库调查了SGLT2抑制剂与其他降糖药物（ATC-A10B）相比与室性心律失常和SCD的报告频率。方法：我们使用网络数据挖掘工具AERSMine从FAERS中挖掘室性心律失常和SCD的报告，以比较SGLT2抑制剂与其他降糖药物。采矿范围从2004年第一季度到2023年第三季度。歧化分析采用95%可信区间的比例报告比（PRR）和95%可信区间的信息分量（IC）。结果：从2004年第一季度到2023年第三季度，SGLT2抑制剂共报告了121129例不良事件，其中ATC-A10B组共报告了1127485例。SGLT2抑制剂组室性心律失常报告频率与对照组相似(1.36/1000 vs 1.55/1000；p = 0.10)， PRR为0.88 （95%CI 0.75-1.03）。然而，SGLT2抑制剂组的SCD报告频率显著低于对照组(1.43 vs 4.70/1000；结论：在本次药物警戒评估中，与SGLT2抑制剂相关的室性心律失常报告频率与其他降糖药物相似，而与SGLT2抑制剂相关的SCD报告频率较低。这个真实世界的研究证据补充了现有的临床证据。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cardiovascular Drugs and Therapy 医学-心血管系统

CiteScore

8.30

自引率

0.00%

发文量

110

审稿时长

4.5 months

期刊介绍： Designed to objectively cover the process of bench to bedside development of cardiovascular drug, device and cell therapy, and to bring you the information you need most in a timely and useful format, Cardiovascular Drugs and Therapy takes a fresh and energetic look at advances in this dynamic field. Homing in on the most exciting work being done on new therapeutic agents, Cardiovascular Drugs and Therapy focusses on developments in atherosclerosis, hyperlipidemia, diabetes, ischemic syndromes and arrhythmias. The Journal is an authoritative source of current and relevant information that is indispensable for basic and clinical investigators aiming for novel, breakthrough research as well as for cardiologists seeking to best serve their patients. Providing you with a single, concise reference tool acknowledged to be among the finest in the world, Cardiovascular Drugs and Therapy is listed in Web of Science and PubMed/Medline among other abstracting and indexing services. The regular articles and frequent special topical issues equip you with an up-to-date source defined by the need for accurate information on an ever-evolving field. Cardiovascular Drugs and Therapy is a careful and accurate guide through the maze of new products and therapies which furnishes you with the details on cardiovascular pharmacology that you will refer to time and time again.