PMID- 36339230
OWN - NLM
STAT- MEDLINE
DCOM- 20221108
LR  - 20230125
IS  - 2296-2565 (Electronic)
IS  - 2296-2565 (Linking)
VI  - 10
DP  - 2022
TI  - Gastrointestinal adverse events associated with semaglutide: A pharmacovigilance 
      study based on FDA adverse event reporting system.
PG  - 996179
LID - 10.3389/fpubh.2022.996179 [doi]
LID - 996179
AB  - BACKGROUND: Semaglutide was approved for treatment of type 2 diabetes mellitus 
      (T2DM) and chronic weight management in obesity or overweight adults. However, 
      real-world data regarding its long-term gastrointestinal safety and tolerability 
      in large sample population are incomplete. We evaluated semaglutide-associated 
      gastrointestinal safety signals by data mining of the FDA pharmacovigilance 
      database. METHODS: Reporting odds ratio (ROR) was employed to quantify the 
      signals of semaglutide-related gastrointestinal adverse events (AEs) from 2018 to 
      2022. Serious and non-serious cases were compared by Mann-Whitney U test or 
      Chi-squared (chi(2)) test, and signals were prioritized using a rating scale. 
      RESULTS: We identified 5,442 cases of semaglutide-associated gastrointestinal 
      AEs, with 45 signals detected, ranging from a ROR(025) of 1.01 (hypoaesthesia 
      oral) to 42.03 (eructation), among which 17 AEs were identified as new and 
      unexpected signals. Patient age (p < 0.001) and body weight (p = 0.006) rather 
      than sex (p = 0.251) might be associated with an increased risk of 
      gastrointestinal AEs severity. Notably, the association between semaglutide and 
      gastrointestinal disorders remained when stratified by age, body weight, sex and 
      reporter type. One strong, 22 moderate and 22 weak clinical priority signals were 
      defined. The median time-to-onset (TTO) for strong clinical priority signal was 
      23 days, while for moderate and weak, they were 6 and 7 days, respectively. All 
      of the disproportionality signals had early failure type features, suggesting 
      that the risk of gastrointestinal AEs occurrence gradually decreased over time. 
      CONCLUSION: Our study provided a deeper and broader understanding of 
      semaglutide's gastrointestinal safety profiles, which would help healthcare 
      professionals to mitigate the risk of gastrointestinal AEs in clinical practice.
CI  - Copyright (c) 2022 Shu, He, Wu, Liu, Ding and Zhang.
FAU - Shu, Yamin
AU  - Shu Y
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
FAU - He, Xucheng
AU  - He X
AD  - Department of Pharmacy, Pengzhou Second People's Hospital, Pengzhou, China.
FAU - Wu, Pan
AU  - Wu P
AD  - Department of Pharmacy, Chengfei Hospital, Chengdu, China.
FAU - Liu, Yanxin
AU  - Liu Y
AD  - Department of Pharmacy, Pengzhou People's Hospital, Pengzhou, China.
FAU - Ding, Yufeng
AU  - Ding Y
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
FAU - Zhang, Qilin
AU  - Zhang Q
AD  - Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20221020
PL  - Switzerland
TA  - Front Public Health
JT  - Frontiers in public health
JID - 101616579
RN  - 53AXN4NNHX (semaglutide)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Pharmacovigilance
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Body Weight
PMC - PMC9631444
OTO - NOTNLM
OT  - FAERS
OT  - data mining
OT  - gastrointestinal adverse events
OT  - pharmacovigilance
OT  - semaglutide
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- 2022/11/08 06:00
MHDA- 2022/11/09 06:00
PMCR- 2022/10/20
CRDT- 2022/11/07 04:41
PHST- 2022/07/17 00:00 [received]
PHST- 2022/09/30 00:00 [accepted]
PHST- 2022/11/07 04:41 [entrez]
PHST- 2022/11/08 06:00 [pubmed]
PHST- 2022/11/09 06:00 [medline]
PHST- 2022/10/20 00:00 [pmc-release]
AID - 10.3389/fpubh.2022.996179 [doi]
PST - epublish
SO  - Front Public Health. 2022 Oct 20;10:996179. doi: 10.3389/fpubh.2022.996179. 
      eCollection 2022.