PMID- 38390214
OWN - NLM
STAT- MEDLINE
DCOM- 20240226
LR  - 20240306
IS  - 1664-2392 (Print)
IS  - 1664-2392 (Electronic)
IS  - 1664-2392 (Linking)
VI  - 15
DP  - 2024
TI  - Psychiatric adverse events associated with GLP-1 receptor agonists: a real-world 
      pharmacovigilance study based on the FDA Adverse Event Reporting System database.
PG  - 1330936
LID - 10.3389/fendo.2024.1330936 [doi]
LID - 1330936
AB  - BACKGROUND: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are widely used 
      due to their profound efficacy in glycemic control and weight management. Within 
      real-world contexts, the manifestation of certain psychiatric adverse events 
      (AEs) has been observed, which is potentially linked to the administration of 
      GLP-1 RAs. The objective of this study was to undertake a comprehensive 
      investigation and characterization of the psychiatric AEs associated with GLP-1 
      RAs. METHODS: We retrieved reports of AEs associated with treatment with GLP-1 
      RAs during the period from the first quarter (Q1) of 2004 to Q1 2023 from the FDA 
      Adverse Event Reporting System (FAERS) database. Descriptive analysis was 
      performed to examine the clinical characteristics and time to onset of the 
      psychiatric AEs caused by GLP-1 RAs. Moreover, disproportionality analyses were 
      performed using the reporting odds ratio (ROR) to identify GLP-1 RA-related 
      psychiatric AEs. RESULTS: A total of 8,240 reports of psychiatric AEs were 
      analyzed out of 181,238 AE reports with treatment with GLP-1 RAs. Among these 
      cases, a higher percentage was represented by women compared to men (65.89% vs. 
      30.96%). The median age of these patients was 56 years, with an interquartile 
      range (IQR) of 48-67 years, based on data available in 286 case reports. This 
      study showed that the median time to onset of the overall GLP-1 RA-related AEs 
      was 31 days (IQR = 7-145.4 days), which varied among GLP-1 RA regimens. 
      Specifically, exenatide had a significantly longer onset time at 45 days (IQR = 
      11-213 days), with statistically significant differences from the onset times of 
      the other five GLP-1 RAs (p< 0.0001). Moreover, eight categories of psychiatric 
      AEs, namely, nervousness (ROR = 1.97, 95% CI = 1.85-2.11), stress (ROR = 1.28, 
      95% CI = 1.19-1.38), eating disorder (ROR = 1.57, 95% CI = 1.40-1.77), fear of 
      injection (ROR = 1.96, 95% CI = 1.60-2.40), sleep disorder due to general medical 
      condition-insomnia type (ROR = 2.01, 95% CI = 1.60-2.52), binge eating (ROR = 
      2.70, 95% CI = 1.75-4.16), fear of eating (ROR 3.35, 95% CI = 1.65-6.78), and 
      self-induced vomiting (ROR = 3.77, 95% CI = 1.77-8.03), were defined as GLP-1 
      RA-related psychiatric AEs through disproportionality analysis. CONCLUSION: Our 
      findings demonstrate a significant association between GLP-1 RAs and the 
      development of specific psychiatric AEs. Despite the observational nature of this 
      pharmacovigilance study and the inherent limitations of the FAERS database, our 
      preliminary findings in this work could provide a better basis for understanding 
      the potential psychiatric AEs that may occur with GLP-1 RA treatment, assisting 
      clinicians to focus on these AEs and provide early intervention for optimal risk 
      management.
CI  - Copyright (c) 2024 Chen, Cai, Zou and Fu.
FAU - Chen, Wei
AU  - Chen W
AD  - Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei, China.
FAU - Cai, Peishan
AU  - Cai P
AD  - Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei, China.
FAU - Zou, Wenbin
AU  - Zou W
AD  - Department of Thoracic Surgery, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei, China.
FAU - Fu, Zhiwen
AU  - Fu Z
AD  - Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, Hubei, China.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20240206
PL  - Switzerland
TA  - Front Endocrinol (Lausanne)
JT  - Frontiers in endocrinology
JID - 101555782
RN  - 0 (Glucagon-Like Peptide-1 Receptor Agonists)
RN  - 89750-14-1 (Glucagon-Like Peptide 1)
SB  - IM
MH  - Male
MH  - Humans
MH  - Female
MH  - Middle Aged
MH  - Aged
MH  - *Glucagon-Like Peptide-1 Receptor Agonists
MH  - Pharmacovigilance
MH  - *Binge-Eating Disorder
MH  - Databases, Factual
MH  - Glucagon-Like Peptide 1/adverse effects
PMC - PMC10882716
OTO - NOTNLM
OT  - FAERS database
OT  - disproportionality analyses
OT  - glucagon-like peptide-1 receptor agonists
OT  - pharmacovigilance study
OT  - psychiatric adverse events
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- 2024/02/23 06:42
MHDA- 2024/02/26 06:43
PMCR- 2024/01/01
CRDT- 2024/02/23 03:53
PHST- 2023/10/31 00:00 [received]
PHST- 2024/01/02 00:00 [accepted]
PHST- 2024/02/26 06:43 [medline]
PHST- 2024/02/23 06:42 [pubmed]
PHST- 2024/02/23 03:53 [entrez]
PHST- 2024/01/01 00:00 [pmc-release]
AID - 10.3389/fendo.2024.1330936 [doi]
PST - epublish
SO  - Front Endocrinol (Lausanne). 2024 Feb 6;15:1330936. doi: 
      10.3389/fendo.2024.1330936. eCollection 2024.