Real-World Adverse Event Profile of Glucagon-Like Peptide-1 Receptor Agonists in Overweight and Obese US Adults
Author(s)
Rohan Vashi, PharmD, MS, David Iwanyckyj, BA, Pablo Racana, BS, Melanie Jardim, PhD.
Amplity, Langhorne, PA, USA.
Amplity, Langhorne, PA, USA.
Presentation Documents
OBJECTIVES: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are an effective therapy for type 2 diabetes and weight loss. Growing popularity of GLP-1 RAs in multiple patient populations may result in a different adverse event (AE) profile than reported in prescribing information. This research aims to determine the real-world adverse event profile of GLP-1 RAs.
METHODS: Natural language processing (NLP) was used to search and analyze the Amplity AnswerY™ real-world database, composed of AI and NLP compliantly reviewed US-based transcribed physician notes, for patients who had received any GLP-1 RA from January 1, 2017, to October 30, 2024. AEs were identified from a pre-defined list compiled from product websites and described as frequencies and percentages. Results are summarized for all GLP-1 RA utilizing patients, overweight or obese patients with and without diabetes, and BMI <25, 25-26, 27-29, and ≥30.
RESULTS: AnswerY identified 124,400 patients utilizing a GLP-1 RA. Among overweight or obese patients, patients with diabetes comprised 92.4% (n=50,079) of the population. BMI cohorts (<25, 25-26, 27-29, and 30+) identified 213, 469, 1123, and 3895 patients respectively. Among all patients reporting AEs, gastrointestinal issues were the most frequently reported common AEs (7.7%), with 4.4% related to treatment and 2.2% leading to treatment disruption. Rates of gastrointestinal issues decreased as BMI increased (12.2%/12.2%/10.0%/7.0%) and were lower among patients with or without diabetes (7.7%/7.4%). Serious AEs were present in 3.9% of patients utilizing GLP-1 RAs, the most common being hypoglycemia (0.6%) and pancreatitis (0.9%). Rates of serious AEs were greater in overweight or obese patients with diabetes (4.3%) compared with patients with no diabetes (1.9%).
CONCLUSIONS: Based on the AnswerY database, gastrointestinal issues were present in all BMI and diabetes cohorts, with rates decreasing as BMI increased. Findings indicated that diabetes and increased BMI appeared to increase serious AE rates, suggesting a need for increased patient monitoring.
METHODS: Natural language processing (NLP) was used to search and analyze the Amplity AnswerY™ real-world database, composed of AI and NLP compliantly reviewed US-based transcribed physician notes, for patients who had received any GLP-1 RA from January 1, 2017, to October 30, 2024. AEs were identified from a pre-defined list compiled from product websites and described as frequencies and percentages. Results are summarized for all GLP-1 RA utilizing patients, overweight or obese patients with and without diabetes, and BMI <25, 25-26, 27-29, and ≥30.
RESULTS: AnswerY identified 124,400 patients utilizing a GLP-1 RA. Among overweight or obese patients, patients with diabetes comprised 92.4% (n=50,079) of the population. BMI cohorts (<25, 25-26, 27-29, and 30+) identified 213, 469, 1123, and 3895 patients respectively. Among all patients reporting AEs, gastrointestinal issues were the most frequently reported common AEs (7.7%), with 4.4% related to treatment and 2.2% leading to treatment disruption. Rates of gastrointestinal issues decreased as BMI increased (12.2%/12.2%/10.0%/7.0%) and were lower among patients with or without diabetes (7.7%/7.4%). Serious AEs were present in 3.9% of patients utilizing GLP-1 RAs, the most common being hypoglycemia (0.6%) and pancreatitis (0.9%). Rates of serious AEs were greater in overweight or obese patients with diabetes (4.3%) compared with patients with no diabetes (1.9%).
CONCLUSIONS: Based on the AnswerY database, gastrointestinal issues were present in all BMI and diabetes cohorts, with rates decreasing as BMI increased. Findings indicated that diabetes and increased BMI appeared to increase serious AE rates, suggesting a need for increased patient monitoring.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
RWD130
Topic
Real World Data & Information Systems
Topic Subcategory
Health & Insurance Records Systems
Disease
SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity)