Difference in Gastrointestinal Risk Associated with Use of GLP-1 Receptor Agonists: A Real-World Pharmacovigilance Study

Yu Zhou,1 Mingyu Chen,1 Libin Liu,2 Zhou Chen1 1Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy, Fujian Medical University, Fuzhou, People’s Republic of China; 2Department of Endocrinology, Fujian Medical University Union Hospital, Fuzhou, People’s Republic of ChinaCo...

Full description

Bibliographic Details
Main Authors: Zhou Y, Chen M, Liu L, Chen Z
Format: Article
Language:English
Published: Dove Medical Press 2022-01-01
Series:Diabetes, Metabolic Syndrome and Obesity
Subjects:
Online Access:https://www.dovepress.com/difference-in-gastrointestinal-risk-associated-with-use-of-glp-1-recep-peer-reviewed-fulltext-article-DMSO
_version_ 1811173913839796224
author Zhou Y
Chen M
Liu L
Chen Z
author_facet Zhou Y
Chen M
Liu L
Chen Z
author_sort Zhou Y
collection DOAJ
description Yu Zhou,1 Mingyu Chen,1 Libin Liu,2 Zhou Chen1 1Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy, Fujian Medical University, Fuzhou, People’s Republic of China; 2Department of Endocrinology, Fujian Medical University Union Hospital, Fuzhou, People’s Republic of ChinaCorrespondence: Zhou Chen; Libin Liu Tel +86-591-22862587; +86-591-86218562Email chenzhou@fjmu.edu.cn; libinliu@fjmu.edu.cnBackground: Glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1RAs) are promising weight-loss drugs, but real-world data concerning the liability of GLP-1RAs in gastrointestinal safety are lacking. We examined the differences in gastrointestinal safety between semaglutide and liraglutide.Materials and Methods: We used the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database and retrieved data during the first three years of semaglutide and liraglutide approved by the FDA. Thirteen main gastrointestinal adverse drug reactions (GADRs) were evaluated. Patient demographics, treatment information, and outcome of events were summarized. Disproportionality analyses were conducted by estimating the reporting odds ratios (RORs) and 95% confidence intervals (CIs).Results: In the reported cases of semaglutide (n = 2047) and liraglutide (n = 4175), semaglutide had a higher pooled ROR and later pooled time-to-onset median of GADRs compared with those of liraglutide (5.53, 95% CI 5.23– 5.85 vs 3.95, 95% CI 3.81– 4.10; 7 days, Q1–Q3: 0– 48 vs 4 days, Q1–Q3: 0– 34.5). The thirteen GADRs associated with these two GLP-1RAs showed a significant difference in the profile of reporting risk and time-to-onset.Conclusion: GLP-1RAs produce a spectrum of distinct classes of GADRs. The individual properties of GADRs between semaglutide and liraglutide might enable incretin-based treatment of obesity to be “tailored” to the needs of each patient.Keywords: GLP-1 receptor agonists, gastrointestinal adverse drug reactions, pharmacovigilance database
first_indexed 2024-04-10T17:54:43Z
format Article
id doaj.art-1516b354a90c4fcc8927a85abe4b137c
institution Directory Open Access Journal
issn 1178-7007
language English
last_indexed 2024-04-10T17:54:43Z
publishDate 2022-01-01
publisher Dove Medical Press
record_format Article
series Diabetes, Metabolic Syndrome and Obesity
spelling doaj.art-1516b354a90c4fcc8927a85abe4b137c2023-02-02T18:44:26ZengDove Medical PressDiabetes, Metabolic Syndrome and Obesity1178-70072022-01-01Volume 1515516372258Difference in Gastrointestinal Risk Associated with Use of GLP-1 Receptor Agonists: A Real-World Pharmacovigilance StudyZhou YChen MLiu LChen ZYu Zhou,1 Mingyu Chen,1 Libin Liu,2 Zhou Chen1 1Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy, Fujian Medical University, Fuzhou, People’s Republic of China; 2Department of Endocrinology, Fujian Medical University Union Hospital, Fuzhou, People’s Republic of ChinaCorrespondence: Zhou Chen; Libin Liu Tel +86-591-22862587; +86-591-86218562Email chenzhou@fjmu.edu.cn; libinliu@fjmu.edu.cnBackground: Glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1RAs) are promising weight-loss drugs, but real-world data concerning the liability of GLP-1RAs in gastrointestinal safety are lacking. We examined the differences in gastrointestinal safety between semaglutide and liraglutide.Materials and Methods: We used the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database and retrieved data during the first three years of semaglutide and liraglutide approved by the FDA. Thirteen main gastrointestinal adverse drug reactions (GADRs) were evaluated. Patient demographics, treatment information, and outcome of events were summarized. Disproportionality analyses were conducted by estimating the reporting odds ratios (RORs) and 95% confidence intervals (CIs).Results: In the reported cases of semaglutide (n = 2047) and liraglutide (n = 4175), semaglutide had a higher pooled ROR and later pooled time-to-onset median of GADRs compared with those of liraglutide (5.53, 95% CI 5.23– 5.85 vs 3.95, 95% CI 3.81– 4.10; 7 days, Q1–Q3: 0– 48 vs 4 days, Q1–Q3: 0– 34.5). The thirteen GADRs associated with these two GLP-1RAs showed a significant difference in the profile of reporting risk and time-to-onset.Conclusion: GLP-1RAs produce a spectrum of distinct classes of GADRs. The individual properties of GADRs between semaglutide and liraglutide might enable incretin-based treatment of obesity to be “tailored” to the needs of each patient.Keywords: GLP-1 receptor agonists, gastrointestinal adverse drug reactions, pharmacovigilance databasehttps://www.dovepress.com/difference-in-gastrointestinal-risk-associated-with-use-of-glp-1-recep-peer-reviewed-fulltext-article-DMSOglp-1 receptor agonistsgastrointestinal adverse drug reactionspharmacovigilance database
spellingShingle Zhou Y
Chen M
Liu L
Chen Z
Difference in Gastrointestinal Risk Associated with Use of GLP-1 Receptor Agonists: A Real-World Pharmacovigilance Study
Diabetes, Metabolic Syndrome and Obesity
glp-1 receptor agonists
gastrointestinal adverse drug reactions
pharmacovigilance database
title Difference in Gastrointestinal Risk Associated with Use of GLP-1 Receptor Agonists: A Real-World Pharmacovigilance Study
title_full Difference in Gastrointestinal Risk Associated with Use of GLP-1 Receptor Agonists: A Real-World Pharmacovigilance Study
title_fullStr Difference in Gastrointestinal Risk Associated with Use of GLP-1 Receptor Agonists: A Real-World Pharmacovigilance Study
title_full_unstemmed Difference in Gastrointestinal Risk Associated with Use of GLP-1 Receptor Agonists: A Real-World Pharmacovigilance Study
title_short Difference in Gastrointestinal Risk Associated with Use of GLP-1 Receptor Agonists: A Real-World Pharmacovigilance Study
title_sort difference in gastrointestinal risk associated with use of glp 1 receptor agonists a real world pharmacovigilance study
topic glp-1 receptor agonists
gastrointestinal adverse drug reactions
pharmacovigilance database
url https://www.dovepress.com/difference-in-gastrointestinal-risk-associated-with-use-of-glp-1-recep-peer-reviewed-fulltext-article-DMSO
work_keys_str_mv AT zhouy differenceingastrointestinalriskassociatedwithuseofglp1receptoragonistsarealworldpharmacovigilancestudy
AT chenm differenceingastrointestinalriskassociatedwithuseofglp1receptoragonistsarealworldpharmacovigilancestudy
AT liul differenceingastrointestinalriskassociatedwithuseofglp1receptoragonistsarealworldpharmacovigilancestudy
AT chenz differenceingastrointestinalriskassociatedwithuseofglp1receptoragonistsarealworldpharmacovigilancestudy