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Cardiovascular adverse events associated with targeted therapies for multiple myeloma: a pharmacovigilance study
Yanli Zhang1, Chang Shan1, Xinxin Zhang1
1Department of Cardiology, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China.
Introduction:
Multiple myeloma (MM) is a leading cause of hematopoietic cancer-related mortality, accounting for 20% of deaths. MM-targeted therapies have demonstrated efficacy, and since 2015, the United States Food and Drug Administration (FDA) has approved five targeted drugs. However, their cardiovascular safety has not been comprehensively evaluated.
Objective:
This study aimed to investigate the association between MM-targeted therapy and cardiovascular adverse events (AEs).
Methods:
Disproportionality analysis was conducted on reports from the FDA AE Reporting System database from 2014 to the second quarter of 2023. Cardiovascular AEs were grouped into nine narrow categories using the Standardized Medical Dictionary for Regulatory Activities Queries (SMQs).
Results:
A total of 3,228 cardiovascular AE cases involving MM-targeted therapy were extracted and analyzed. Significant disproportionality was identified for daratumumab, elotuzumab, and isatuximab. Among the nine narrow SMQ categories, the three most reported cardiovascular AEs were cardiomyopathy, cardiac arrhythmias, and embolic and thrombotic events. Noninfectious myocarditis/pericarditis, cardiac arrhythmias, and embolic and thrombotic events exhibited the strongest signal strengths. The cardiovascular AE risk was higher within the first month and gradually decreased thereafter; however, it increased rapidly again after 1 year. This trend was observed for all cardiovascular AEs. The Kaplan-Meier curve and the log-rank test revealed that isatuximab and elotuzumab exhibited a significantly lower probability of cardiovascular AEs than daratumumab (p < 0.001).
Conclusions:
MM-targeted therapy is significantly associated with an increased risk of previously unknown cardiovascular AE profiles, with the range and onset differing among various drugs, thereby warranting specific monitoring and appropriate management.
Insights
Multiple myeloma therapies carry cardiovascular risks, with specific drugs like daratumumab showing higher adverse event rates. Monitoring is crucial due to varying drug-specific risks and onset times.
Area of Science:
- Hematology and Oncology
- Cardiovascular Medicine
- Pharmacovigilance
Background:
- Multiple myeloma (MM) is a significant cause of cancer mortality.
- Recent FDA approvals have expanded MM-targeted therapies.
- Comprehensive cardiovascular safety data for these therapies are lacking.
Purpose of the Study:
- To investigate the association between MM-targeted therapies and cardiovascular adverse events (AEs).
- To identify specific cardiovascular AE profiles and drug-specific risks.
Main Methods:
- Disproportionality analysis of FDA AE Reporting System data (2014-2023).
- Categorization of cardiovascular AEs using Standardized Medical Dictionary for Regulatory Activities Queries (SMQs).
- Comparison of AE risk profiles across different MM-targeted drugs.
Main Results:
- 3,228 cardiovascular AE cases linked to MM-targeted therapy were identified.
- Daratumumab, elotuzumab, and isatuximab showed significant disproportionality for cardiovascular AEs.
- Cardiomyopathy, cardiac arrhythmias, and embolic/thrombotic events were most frequent; noninfectious myocarditis/pericarditis showed strong signals.
- Cardiovascular AE risk peaked within the first month, decreased, then rose again after one year.
- Isatuximab and elotuzumab had lower cardiovascular AE probabilities than daratumumab (p < 0.001).
Conclusions:
- MM-targeted therapies are associated with distinct cardiovascular AE profiles.
- Cardiovascular risk varies by drug and onset time, necessitating tailored monitoring.
- Specific management strategies are required for patients on MM-targeted therapies.
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