Abstract:

Calcineurin inhibitors (CNIs) have significantly enhanced both organ and patient survival rates following transplantation. However, their safety profile remains a concern due to the heightened risk of ventricular hypertrophy, a condition that can be life-threatening. This study aimed to evaluate the clinical characteristics, population-specific risks, and contributing factors to fatal outcomes associated with CNI-induced ventricular hypertrophy. We conducted an observational, retrospective pharmacovigilance analysis utilizing real-world data from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database, spanning from its inception until the third quarter of 2023. A total of 131 cases of CNI-related ventricular hypertrophy were identified, with our findings demonstrating a significant correlation between CNIs and ventricular hypertrophy [ROR = 3.03 (2.54–3.61), IC = 1.55 (1.29–1.81)]. Male patients were found to have an increased risk of fatal outcomes in CNI-associated ventricular hypertrophy (P = 0.005). Given these findings, clinicians are urged to maintain heightened vigilance regarding this severe complication. Regular and comprehensive cardiac function assessments, including both global and regional cardiac evaluations, are particularly recommended for patients on long-term CNI therapy, with a specific focus on older male individuals.

Key words: Calcineurin inhibitors, Ventricular hypertrophy, Hypertrophic cardiomyopathy, FDA Adverse Events Reporting System, Pharmacovigilance, Disproportionality analysis, Real-world study