Gastrointestinal Safety Assessment of GLP-1 Receptor Agonists in the US: A Real-World Adverse Events Analysis from the FAERS Database
<b>Background:</b> Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are commonly used to treat obesity and diabetes but are linked to a variety of gastrointestinal (GI) adverse events (AEs). Real-world data on GLP-1 RA-related GI AEs and outcomes are limited. This study assessed GI...
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2024-12-01
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| author | Samuel Prince Osei Edwin Akomaning Teodora Francesca Florut Mohit Sodhi Brian E. Lacy Wafa A. Aldhaleei Akshaya Srikanth Bhagavathula |
| author_facet | Samuel Prince Osei Edwin Akomaning Teodora Francesca Florut Mohit Sodhi Brian E. Lacy Wafa A. Aldhaleei Akshaya Srikanth Bhagavathula |
| author_sort | Samuel Prince Osei |
| collection | DOAJ |
| description | <b>Background:</b> Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are commonly used to treat obesity and diabetes but are linked to a variety of gastrointestinal (GI) adverse events (AEs). Real-world data on GLP-1 RA-related GI AEs and outcomes are limited. This study assessed GI AEs and adverse outcomes using the US FDA Adverse Event Reporting System (FAERS). <b>Methods:</b> This retrospective pharmacovigilance study used the US FDA FAERS database (2007–2023). We searched GLP-1 RA medications, AEs, and adverse outcomes. Demographic, treatment indication, and AE data were collected. Descriptive analysis involved frequencies and percentages, while reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and multivariate logistic regression were used to analyze GLP-1 RA-related GI AEs and outcomes. <b>Results:</b> From 2007 to 2023, a total of 187,757 AEs were reported with GLP-1 RAs, and 16,568 were GLP-1 RA-associated GI AEs in the US. Semaglutide was linked to higher odds of nausea (IC<sub>025</sub>: 0.151, β<sub>Coeff</sub>: 0.314), vomiting (IC<sub>025</sub>: 0.334, β<sub>Coeff</sub>: 0.495), and delayed gastric emptying (IC<sub>025</sub>: 0.342, β<sub>Coeff</sub>: 0.453). Exenatide was associated with pancreatitis (IC<sub>025</sub>: 0.601, β<sub>Coeff</sub>: 0.851) and death (ROR: 4.50, IC<sub>025</sub>: 1.101). Overall, semaglutide had a broader range of notable adverse effects; by comparison, dulaglutide and liraglutide use was associated with fewer significant GI AEs. <b>Conclusions:</b> Analysis of the FAERS data reveals that GLP-1 RAs, particularly semaglutide and exenatide, are significantly associated with specific GI AEs, such as nausea, vomiting, delayed gastric emptying, and pancreatitis. Clinicians should be aware of these potential risks to ensure optimal monitoring and patient safety. This study demonstrated the utility of pharmacovigilance data in identifying safety signals, which can inform future pharmacoepidemiological investigations to confirm causal relationships. Clinicians should be aware of these potential risks to ensure optimal monitoring and patient safety. |
| format | Article |
| id | doaj-art-71268045f4af4e49ab97a269aedade20 |
| institution | OA Journals |
| issn | 2075-4418 |
| language | English |
| publishDate | 2024-12-01 |
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| spelling | doaj-art-71268045f4af4e49ab97a269aedade202025-08-20T02:00:37ZengMDPI AGDiagnostics2075-44182024-12-011424282910.3390/diagnostics14242829Gastrointestinal Safety Assessment of GLP-1 Receptor Agonists in the US: A Real-World Adverse Events Analysis from the FAERS DatabaseSamuel Prince Osei0Edwin Akomaning1Teodora Francesca Florut2Mohit Sodhi3Brian E. Lacy4Wafa A. Aldhaleei5Akshaya Srikanth Bhagavathula6Department of Public Health, North Dakota State University, Fargo, ND 58108, USADepartment of Public Health, North Dakota State University, Fargo, ND 58108, USAFaculty of Health Sciences, Simon Fraser University, Burnaby, BC V5A 1S6, CanadaFaculty of Medicine, University of British Columbia, Vancouver, BC V6T 1Z1, CanadaDivision of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL 32224, USADivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN 55905, USADepartment of Public Health, North Dakota State University, Fargo, ND 58108, USA<b>Background:</b> Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are commonly used to treat obesity and diabetes but are linked to a variety of gastrointestinal (GI) adverse events (AEs). Real-world data on GLP-1 RA-related GI AEs and outcomes are limited. This study assessed GI AEs and adverse outcomes using the US FDA Adverse Event Reporting System (FAERS). <b>Methods:</b> This retrospective pharmacovigilance study used the US FDA FAERS database (2007–2023). We searched GLP-1 RA medications, AEs, and adverse outcomes. Demographic, treatment indication, and AE data were collected. Descriptive analysis involved frequencies and percentages, while reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and multivariate logistic regression were used to analyze GLP-1 RA-related GI AEs and outcomes. <b>Results:</b> From 2007 to 2023, a total of 187,757 AEs were reported with GLP-1 RAs, and 16,568 were GLP-1 RA-associated GI AEs in the US. Semaglutide was linked to higher odds of nausea (IC<sub>025</sub>: 0.151, β<sub>Coeff</sub>: 0.314), vomiting (IC<sub>025</sub>: 0.334, β<sub>Coeff</sub>: 0.495), and delayed gastric emptying (IC<sub>025</sub>: 0.342, β<sub>Coeff</sub>: 0.453). Exenatide was associated with pancreatitis (IC<sub>025</sub>: 0.601, β<sub>Coeff</sub>: 0.851) and death (ROR: 4.50, IC<sub>025</sub>: 1.101). Overall, semaglutide had a broader range of notable adverse effects; by comparison, dulaglutide and liraglutide use was associated with fewer significant GI AEs. <b>Conclusions:</b> Analysis of the FAERS data reveals that GLP-1 RAs, particularly semaglutide and exenatide, are significantly associated with specific GI AEs, such as nausea, vomiting, delayed gastric emptying, and pancreatitis. Clinicians should be aware of these potential risks to ensure optimal monitoring and patient safety. This study demonstrated the utility of pharmacovigilance data in identifying safety signals, which can inform future pharmacoepidemiological investigations to confirm causal relationships. Clinicians should be aware of these potential risks to ensure optimal monitoring and patient safety.https://www.mdpi.com/2075-4418/14/24/2829glucagon-like peptide-1 receptordiabetes mellitusadverse drug reaction reporting systemsgastrointestinal diseasespharmacovigilanceweight loss agents |
| spellingShingle | Samuel Prince Osei Edwin Akomaning Teodora Francesca Florut Mohit Sodhi Brian E. Lacy Wafa A. Aldhaleei Akshaya Srikanth Bhagavathula Gastrointestinal Safety Assessment of GLP-1 Receptor Agonists in the US: A Real-World Adverse Events Analysis from the FAERS Database Diagnostics glucagon-like peptide-1 receptor diabetes mellitus adverse drug reaction reporting systems gastrointestinal diseases pharmacovigilance weight loss agents |
| title | Gastrointestinal Safety Assessment of GLP-1 Receptor Agonists in the US: A Real-World Adverse Events Analysis from the FAERS Database |
| title_full | Gastrointestinal Safety Assessment of GLP-1 Receptor Agonists in the US: A Real-World Adverse Events Analysis from the FAERS Database |
| title_fullStr | Gastrointestinal Safety Assessment of GLP-1 Receptor Agonists in the US: A Real-World Adverse Events Analysis from the FAERS Database |
| title_full_unstemmed | Gastrointestinal Safety Assessment of GLP-1 Receptor Agonists in the US: A Real-World Adverse Events Analysis from the FAERS Database |
| title_short | Gastrointestinal Safety Assessment of GLP-1 Receptor Agonists in the US: A Real-World Adverse Events Analysis from the FAERS Database |
| title_sort | gastrointestinal safety assessment of glp 1 receptor agonists in the us a real world adverse events analysis from the faers database |
| topic | glucagon-like peptide-1 receptor diabetes mellitus adverse drug reaction reporting systems gastrointestinal diseases pharmacovigilance weight loss agents |
| url | https://www.mdpi.com/2075-4418/14/24/2829 |
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