Trends in the use of sodium-glucose cotransporter-2 inhibitors and characteristics of adverse event reporting in patients with heart failure in Japan: reports from the medical administration database and the adverse event reporting database

Heart failure (HF) is a global health issue with a high prevalence in aging populations. Sodium-glucose cotransporter-2 (SGLT2) inhibitors reduce HF-related hospitalizations and mortality; however, their adverse drug events (ADEs) require further evaluation. Using the Japan Medical Data Center and Japanese Adverse Drug Event Report (JADER) databases, we analyzed prescribing trends and ADE risk factors. Multivariate logistic regression assessed associations between patient characteristics and ADEs, adjusting for age, sex, medication use, and comorbidities. Decision tree analyses stratified ADE risks. SGLT2 inhibitor prescriptions increased from 1.63% (2018) to 9.08% (2022), with a notable rise in 2021. JADER analysis showed an increasing number of ADE reports, primarily dehydration, urinary tract infections, and renal impairment. Decision tree analyses identified risk factors: dehydration (age ≥80 years, tolvaptan use), urinary tract infection (female sex, renal dysfunction), and renal impairment (angiotensin receptor-neprilysin inhibitor use, history of renal dysfunction). Personalized risk assessment and monitoring are crucial for optimizing SGLT2 inhibitor therapy, particularly in older patients with HF and renal impairment.