Data mining study on adverse events of tirzepatide based on FAERS database

Area of Science:

• Pharmacovigilance
• Endocrinology
• Clinical Safety

Background:

• Tirzepatide is a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 receptor agonist (GLP-1 RA).
• It is indicated for type 2 diabetes and obesity management.
• Understanding its real-world safety profile is essential.

Purpose of the Study:

• To investigate the safety profile of tirzepatide in real-world clinical settings.
• To identify potential adverse events (AEs) associated with tirzepatide use.
• To analyze the onset patterns of these AEs.

Main Methods:

• Retrospective analysis of AE reports from the FDA Adverse Event Reporting System (FAERS) database (Q2 2022 - Q4 2023).
• Signal mining using the Reporting Odds Ratio (ROR) method.
• Analysis of AE onset time using the Weibull Shape Parameter (WSP).

Main Results:

• 25,215 AE reports for tirzepatide were identified, primarily in individuals aged 65-85.
• Four positive safety signals at the system organ class level and 109 at the preferred terms level were detected.
• Novel signals included thyroid mass, medullary thyroid carcinoma, and reproductive/breast conditions. Most AEs occurred within 30 days, with a WSP of 0.66 indicating early onset.

Conclusions:

• This study identified novel adverse event signals for tirzepatide.
• Findings underscore the importance of vigilant monitoring for tirzepatide.
• Particular attention should be paid to early treatment stages and specific AE profiles.