Glucagon-like peptide-1 receptor agonists and impaired gastric emptying: a pharmacovigilance analysis of the US Food and Drug Administration adverse event reporting system

Haoquan Huang; Chuwen Hu; Fan Liu; Fengtao Ji; Yanni Fu; Minghui Cao

doi:10.1016/j.bja.2024.10.013

Glucagon-like peptide-1 receptor agonists and impaired gastric emptying: a pharmacovigilance analysis of the US Food and Drug Administration adverse event reporting system

Br J Anaesth. 2024 Nov 21:S0007-0912(24)00615-9. doi: 10.1016/j.bja.2024.10.013. Online ahead of print.

Authors

Haoquan Huang¹, Chuwen Hu¹, Fan Liu², Fengtao Ji³, Yanni Fu⁴, Minghui Cao⁵

Affiliations

¹ Department of Anaesthesiology, Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Shanwei, China; Department of Anaesthesiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
² Medical Research Center of Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Shanwei, China.
³ Department of Anaesthesiology, Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Shanwei, China; Department of Anaesthesiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China; Department of Pain Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Shanwei, China. Electronic address: jift@mail.sysu.edu.cn.
⁴ Department of Anaesthesiology, Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Shanwei, China; Department of Anaesthesiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China; Department of Pain Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Shanwei, China. Electronic address: fuyanni@mail.sysu.edu.cn.
⁵ Department of Anaesthesiology, Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Shanwei, China; Department of Anaesthesiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China; Department of Pain Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Shanwei, China. Electronic address: caomh@mail.sysu.edu.cn.

PMID: 39578156
DOI: 10.1016/j.bja.2024.10.013

Abstract

Background: Glucagon-like peptide-1 receptor agonists (GLP-1RAs) potentially increase the risk of pulmonary aspiration resulting from impaired gastric emptying (IGE). We evaluated the association between GLP-1RAs and IGE using the US Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods: We analysed FAERS data from 2004 Q1 to 2024 Q1, identifying the top 10 drugs linked to IGE and determining the proportion of GLP-1RA use. Disproportionality analysis using the reporting odds ratio was conducted to assess the relative IGE risk for each drug. Logistic regression analysed the impact of age, weight, and sex on IGE risk. Cumulative incidence and time to onset of IGE events were examined using Kaplan-Meier and Weibull shape parameter tests.

Results: Among the top 10 drugs associated with IGE reports, five were GLP-1RAs, accounting for 49.5% (982/1982) of cases. Dulaglutide (odds ratio [OR] 0.97, 95% confidence interval [CI] 0.94-1.00, P=0.033) and semaglutide (OR 0.96, 95% CI 0.94-0.97, P=0.001) showed lower IGE risk with older age. For exenatide, higher weight (OR 0.99, 95% CI 0.98-1.00, P=0.033) and male sex (OR 0.39, 95% CI 0.20-0.68, P=0.033) were associated with lower IGE risk. Median onset times ranged from 40.5 days (semaglutide) to 107.5 days (tirzepatide) from intitiation of therapy. The Weibull shape parameter β was <1 for all GLP-1RAs, indicating a higher IGE risk early in treatment.

Conclusions: GLP-1RAs were notably associated with reports of impaired gastric emptying in the FAERS. Age, weight, and sex were significantly associated with impaired gastric emptying risk for certain GLP-1RAs. IGE events tended to occur early in treatment, with risk diminishing over time. These findings provide valuable references for future research on perioperative safety with GLP-1RAs.

Keywords: GLP-1 receptor agonists; adverse drug events; disproportionality analysis; impaired gastric emptying; pharmacovigilance.