Adverse events associated with tirzepatide: a focus on subgroup-specific differences.

Abstract

BACKGROUND: Tirzepatide is anticipated to play a pivotal role in managing overweight/obesity and/or type 2 diabetes. Although prior studies have employed spontaneous reporting databases for large-scale safety monitoring of tirzepatide focusing on novel adverse events, current understanding of potential disparities of the adverse events among subgroups remains unexplored. OBJECTIVE: This study aimed to evaluate the differences of adverse events across subgroups related to tirzepatide. RESEARCH DESIGN AND METHODS: Using the data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) databases, the differences in adverse events across specific subgroups concerning reporter type, sex, age, dose, indication, report year, onset time, and outcome were investigated using the ROR algorithm and Chi-Square Test/Fisher’s exact test. To further verify the differences, subgroup-based stratified analyses and sensitivity analyses were conducted. RESULTS: The results showed that the adverse events related to tirzepatide showed significant difference across subgroups. Notably, males were significantly more inclined to report “gastrointestinal disorders”. Within indication-based subgroups, tirzepatide used in patients with diabetes mellitus was significantly more frequently associated with “gastrointestinal disorders” compared with patients in weight control purpose. CONCLUSION: This study provides contribution for identification potential difference across subgroups, which can guide future research and more targeted monitoring strategies for tirzepatide in clinical practice. Further studies are required to validate these observations. CLINICAL TRIAL NUMBER: Not applicable.