Scholarlink

Background <p>Hypovolemia is one of the most common adverse events (AE) of SGLT2is, which is overlooked, especially in the elderly population.</p> Objective <p>In this study, signal mining of AEs caused by SGLT2is was conducted, and the AE signals related to hypovolemia in the real world after marketing were statistically analyzed, so as to provide reference for reducing AEs and for clinical rational drug use.</p> Methods <p>The FDA adverse event reporting system (FAERS) is an important data source for spontaneous reporting of AEs. A total of 46 quarterly data from 2013 Q1 to 2024 Q2 was extracted for analysis. In this study, disproportionality analysis was used to detect the signals of AEs and four methods including ROR, MHRA, BCPNN, and MGPS were combined.</p> Results <p>5017 AE reports related to SGLT2is induced hypovolemia were included in the analysis. According to the ROR value of signal mining, empagliflozin had a higher risk of hypovolemia (ROR = 13.87), while canagliflozin had a higher risk of hypovolemic shock (ROR = 3.40). In stratification analysis by sex, the risk of hypovolemia-related AEs was higher in females using canagliflozin than in males. The most significant differences were hypovolaemia (female ROR = 10.98 vs. male ROR = 5.56). When stratified by age, it showed that patients &lt; 18&#xa0;years old, 18–44&#xa0;years old, and &gt; 75&#xa0;years old had a higher risk of hypovolemia-related AEs than other age groups.</p> Conclusions <p>Hypovolemia related AEs caused by SGLT2is were found to be more common in women and elderly patients.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Signal mining of adverse drug events related to hypovolemia caused by SGLT2 inhibitors based on FAERS database

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年6月20日

查看全文
  • Huan Li,
  • Ziwan Guan

摘要

Background

Hypovolemia is one of the most common adverse events (AE) of SGLT2is, which is overlooked, especially in the elderly population.

Objective

In this study, signal mining of AEs caused by SGLT2is was conducted, and the AE signals related to hypovolemia in the real world after marketing were statistically analyzed, so as to provide reference for reducing AEs and for clinical rational drug use.

Methods

The FDA adverse event reporting system (FAERS) is an important data source for spontaneous reporting of AEs. A total of 46 quarterly data from 2013 Q1 to 2024 Q2 was extracted for analysis. In this study, disproportionality analysis was used to detect the signals of AEs and four methods including ROR, MHRA, BCPNN, and MGPS were combined.

Results

5017 AE reports related to SGLT2is induced hypovolemia were included in the analysis. According to the ROR value of signal mining, empagliflozin had a higher risk of hypovolemia (ROR = 13.87), while canagliflozin had a higher risk of hypovolemic shock (ROR = 3.40). In stratification analysis by sex, the risk of hypovolemia-related AEs was higher in females using canagliflozin than in males. The most significant differences were hypovolaemia (female ROR = 10.98 vs. male ROR = 5.56). When stratified by age, it showed that patients < 18 years old, 18–44 years old, and > 75 years old had a higher risk of hypovolemia-related AEs than other age groups.

Conclusions

Hypovolemia related AEs caused by SGLT2is were found to be more common in women and elderly patients.