PMID- 34987394
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220107
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 12
DP  - 2021
TI  - Safety of SGLT2 Inhibitors: A Pharmacovigilance Study from 2013 to 2021 Based on 
      FAERS.
PG  - 766125
LID - 10.3389/fphar.2021.766125 [doi]
LID - 766125
AB  - Background: Sodium-glucose co-transporter-2 inhibitors (SGLT2is) are widely used 
      in clinical practice for their demonstrated cardiorenal benefits, but multiple 
      adverse events (AEs) have been reported. We aimed to describe the distribution of 
      SGLT2i-related AEs in different systems and identify important medical event 
      (IME) signals for SGLT2i. Methods: Data from the first quarter (Q1) of 2013-2021 
      Q2 in FAERS were selected to conduct disproportionality analysis. The definition 
      of AEs and IMEs relied on the system organ classes (SOCs) and preferred terms 
      (PTs) by the Medical Dictionary for Regulatory Activities (MedDRA-version 24.0). 
      Two signal indicators, the reported odds ratio (ROR) and information component 
      (IC), were used to estimate the association between SGLT2is and IMEs. Results: A 
      total of 57,818 records related to SGLT2i, with 22,537 SGLT2i-IME pairs. Most 
      SGLT2i-related IMEs occurred in monotherapy (N = 21,408, 94.99%). Significant 
      signals emerged at the following SOCs: "metabolism and nutrition disorders" (N = 
      9,103; IC025 = 4.26), "renal and urinary disorders" (3886; 1.20), "infections and 
      infestations" (3457; 0.85). The common strong signals were observed in diabetic 
      ketoacidosis, ketoacidosis, euglycaemic diabetic ketoacidosis and Fournier's 
      gangrene. Unexpected safety signals such as cellulitis, osteomyelitis, cerebral 
      infarction and nephrolithiasis were detected. Conclusion: Our pharmacovigilance 
      analysis showed that a high frequency was reported for IMEs triggered by SGLT2i 
      monotherapy. Different SGLT2is caused different types and the association 
      strengths of IMEs, while they also shared some specific PTs. Most of the results 
      are generally consistent with previous studies, and more pharmacoepidemiological 
      studies are needed to validate for unexpected AEs. Based on risk-benefit 
      considerations, clinicians should be well informed about important medical events 
      that may be aggravated by SGLT2is.
CI  - Copyright (c) 2021 Zhou, Ye, Guo, Liu, Xu, Hu, Zhai, Gao, Xu, Dong and He.
FAU - Zhou, Xiang
AU  - Zhou X
AD  - School of Medicine, Tongji University, Shanghai, China.
FAU - Ye, Xiaofei
AU  - Ye X
AD  - Department of Health Statistics, Second Military Medical University, Shanghai, 
      China.
FAU - Guo, Xiaojing
AU  - Guo X
AD  - Department of Health Statistics, Second Military Medical University, Shanghai, 
      China.
FAU - Liu, Dongxu
AU  - Liu D
AD  - School of Medicine, Tongji University, Shanghai, China.
FAU - Xu, Jinfang
AU  - Xu J
AD  - Department of Health Statistics, Second Military Medical University, Shanghai, 
      China.
FAU - Hu, Fangyuan
AU  - Hu F
AD  - Department of Health Statistics, Second Military Medical University, Shanghai, 
      China.
FAU - Zhai, Yinghong
AU  - Zhai Y
AD  - School of Medicine, Tongji University, Shanghai, China.
FAU - Gao, Yongqing
AU  - Gao Y
AD  - School of Medicine, Tongji University, Shanghai, China.
FAU - Xu, Xiao
AU  - Xu X
AD  - School of Medicine, Tongji University, Shanghai, China.
FAU - Dong, Ziwei
AU  - Dong Z
AD  - School of Medicine, Tongji University, Shanghai, China.
FAU - He, Jia
AU  - He J
AD  - School of Medicine, Tongji University, Shanghai, China.
AD  - Department of Health Statistics, Second Military Medical University, Shanghai, 
      China.
LA  - eng
PT  - Journal Article
DEP - 20211220
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC8721280
OTO - NOTNLM
OT  - FAERS
OT  - SGLT2 inhibitor
OT  - adverse event
OT  - diabetes
OT  - disproportionality
OT  - important medical events
OT  - pharmacovigilance
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2022/01/07 06:00
MHDA- 2022/01/07 06:01
PMCR- 2021/12/20
CRDT- 2022/01/06 05:52
PHST- 2021/08/28 00:00 [received]
PHST- 2021/11/22 00:00 [accepted]
PHST- 2022/01/06 05:52 [entrez]
PHST- 2022/01/07 06:00 [pubmed]
PHST- 2022/01/07 06:01 [medline]
PHST- 2021/12/20 00:00 [pmc-release]
AID - 766125 [pii]
AID - 10.3389/fphar.2021.766125 [doi]
PST - epublish
SO  - Front Pharmacol. 2021 Dec 20;12:766125. doi: 10.3389/fphar.2021.766125. 
      eCollection 2021.