Author ORCID Identifier

https://orcid.org/0000-0003-4708-294X

Date of Award

Spring 5-15-2024

Degree Type

Capstone Project

Degree Name

Master of Public Health (MPH)

Department

Public Health

First Advisor

Dr. Alexander Kirpich

Second Advisor

Dr. Ike Okosun

Abstract

INTRODUCTION: Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have emerged as a prominent treatment for type-2 diabetes (T2D) and obesity since the FDA’s approval of Exenatide in 2005. The utilization of these medications is projected to increase substantially by 2025, with reports of shortages due to high demand. Concurrently, there are growing concerns about their potential misuse, including using without proper indications and using counterfeit products. Despite their therapeutic benefits, GLP-1RAs have been associated with various adverse events, ranging from mild gastrointestinal symptoms to serious events including hospitalization and pancreatitis. As their utilization increases, there is an urgent need for comprehensive research into the factors associated with serious adverse events (SAEs) and misuse of these medications.

AIM: To investigate factors associated with SAE outcomes and misuse of GLP-1RAs using data from the FDA Adverse Event Reporting System (FAERS). METHODS: This study employed a retrospective observational analysis using FAERS quarterly data files from 2005 to 2023. Multinomial logistic regression was used to examine factors associated with SAE outcomes, while logistic regression was employed to analyze factors related to misuse. The sample included 20,704 reports after applying inclusion and exclusion criteria.

RESULTS: The multinomial logistic regression analysis revealed that compared to death/life-threatening events, each additional year of age decreased the odds of hospitalization/required immediate intervention by 1.2% (OR = 0.988 [0.985 – 0.992]). Female gender and consumer reports were associated with lower odds of fatal SAEs. Semaglutide was associated with higher odds of death/life-threatening outcomes compared to other GLP-1RAs, except for liraglutide in some instances. Misuse of GLP-1RAs was associated with higher odds of hospitalization/required immediate intervention (OR = 1.419 [1.266 – 1.589]). Logistic regression analysis of misuse factors showed that being female (OR = 1.341 [1.262 - 1.425]) and consumer-reported events (OR = 1.468 [1.377 - 1.566]) were associated with higher odds of misuse, while older age (OR = 0.995 [0.993 - 0.997]) was associated with lower odds.

DISCUSSION: This study is the first to investigate factors associated with SAE outcomes and misuse of GLP-1RAs using FAERS data. The findings have significant implications for clinical practice, as these suggest a need for age- and gender-specific risk assessment in GLP-1RA therapy. The study's strengths include its relatively large sample size, the use of multinomial logistic regression, and the inclusion of misuse as an explanatory variable. However, limitations include potential reporting bias and lack of control for certain confounding factors. Future research should address these limitations using more comprehensive data sources and advanced statistical techniques. The increasing utilization of GLP-1RAs and associated SAEs warrants attention from public health agencies, especially with the ongoing development of more convenient administration methods and potential for misuse.

DOI

https://doi.org/10.57709/37401983

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