Mapping the use, effectiveness and safety of the glucagon-like peptide-1 (GLP-1) receptors agonists: a real-world data analysis

• Grant number: 25/03911-1
• Support Opportunities: Scholarships abroad - Research
• Start date: February 02, 2026
• End date: February 01, 2027
• Field of knowledge: Health Sciences - Pharmacy
• Principal Investigator: Fabiana Rossi Varallo
• Grantee: Fabiana Rossi Varallo
• Host Investigator: Mina Tadrous
• Host Institution: Faculdade de Ciências Farmacêuticas de Ribeirão Preto (FCFRP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil
• Institution abroad: University of Toronto (U of T), Canada

Abstract

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have emerged as a significant therapeutic advancement for obesity and type 2 diabetes mellitus. However, their increasing use, particularly for cosmetic weight loss, raises safety concerns. This study aims to map the usage, safety, and effectiveness of GLP-1 RAs in Canada, the United States (US), the European Union (EU), and Brazil from January 1, 2014, to December 31, 2023. It will be conducted in three phases. Phase 1: A systematic review will identify significant drug safety signals and risk factors associated with GLP-1 RAs, following Cochrane Handbook and PRISMA guidelines. Phase 2: A cross-sectional analysis of individual case safety reports (ICSRs) from Health Canada, the Food and Drug Administration, European Medicines Agency, and Brazilian Sanitary Surveillance Agency will evaluate drug safety signals, therapeutic failure, and data completeness. Variables collected will include demographics (sex, age), medication suspected (dose, route of administration, monotherapy vs combination therapy), and adverse event (unfavorable outcomes, seriousness) characteristics. Phase 3: A repeated cross-sectional study using IQVIA MIDAS database will assess GLP-1 RAs utilization and dose distribution among high, middle and low-income countires. The protocol and reports of observational studies will adhere to the STROBE statement. Findings will provide real-world evidence on GLP-1 RA prescribing patterns, safety, and effectiveness, which could contribute to clinical and regulatory decision-making. (AU)