Cardio-oncology & otherResearch article
Cardiac adverse events associated with dual immune checkpoint inhibitors: a pharmacovigilance analysis from the FDA adverse event reporting system
- pharmacovigilance analysis
- disproportionality analysis
Authors' conclusion
This study identified distinct associations between different dual ICIs treatment strategies and various cardiac adverse events. We further identified potential risk factors and co-reported symptoms of cardiotoxicity, which may aid in the early diagnosis and monitoring of ICI-associated cardiac adverse events.
Study context
- Population
- Cancer patients receiving dual immune checkpoint inhibitors with cardiac adverse event reports in FAERS, first quarter of 2015 to fourth quarter of 2024
- Comparison
- association between different dual immune checkpoint inhibitors (ICIs) and cardiac adverse events
Main finding
As reported in the abstract
Cardiac adverse events accounted for this share of all ICI adverse event reports in the FAERS database
7.5%
Further findings
Significant preferred term (PT) signals and life-threatening outcomes by dual ICI
- Nivolumab plus ipilimumab was associated with the highest number of significant preferred term (PT) signals
- durvalumab plus tremelimumab had the highest percentage of life-threatening outcomes
Onset time of cardiac adverse events following dual ICIs therapy
- median onset time
- 32 days (IQR 15-77)
Co-reported conditions
- Myositis and myasthenia gravis were the most commonly co-reported extracardiac conditions in myocarditis cases
- complete atrioventricular block and cardiogenic shock were the most frequently reported intracardiac complications
Risk factors for cardiac adverse events
- Older patients, males, and those with kidney cancer were at higher risk of developing cardiac adverse events
Original publication
Summarised from the published abstract; every number is checked against it