Safety Assessment of Glucagon-Like Peptide 1 Receptor Agonists Based on the FAERS Database: Focus on Tumorigenic Risk...

Area of Science:

• Pharmacovigilance
• Endocrinology
• Oncology

Background:

• Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are widely prescribed for Type 2 diabetes.
• Clinical observations suggest potential adverse events, including an association with tumor development, warranting further investigation.

Purpose of the Study:

• To investigate the association between GLP-1RAs and adverse events, with a specific focus on tumorigenic risks.
• To analyze the influence of patient demographics (age, sex, weight) on GLP-1RA-related tumor risks.

Main Methods:

• Utilized data from the FDA Adverse Event Reporting System (FAERS) spanning Q1 2005 to Q4 2023.
• Employed the proportional reporting ratio (PRR) method to identify and quantify GLP-1RA-associated adverse events.
• Conducted detailed analyses of event distribution across demographics, focusing on tumor-related events.

Main Results:

• A total of 195,250 GLP-1RA-related adverse event reports were identified across 25 system organ classes.
• Gastrointestinal disorders, investigative findings, and metabolism/nutrition disorders were the most frequently reported.
• 7,457 reports involved tumors (benign, malignant, unspecified) with a PRR of 0.5.
• Tumorigenesis risk associated with GLP-1RAs demonstrated variability across different age groups, genders, and body weights.

Conclusions:

• GLP-1RA use is associated with a range of adverse events, including a notable incidence of tumor development.
• The risk of tumorigenesis appears to be influenced by patient-specific factors such as age, sex, and body weight.
• Clinical practice should incorporate patient-specific risk assessments to ensure the safe and effective use of GLP-1RAs, particularly in vulnerable subpopulations.