Cardiovascular complications of modern multiple myeloma therapy: A pharmacovigilance study
Zaki Al-Yafeai1, Mohamed Ghoweba2, Anil Ananthaneni1
1Department of Internal Medicine, Louisiana State University Health Sciences Center-Shreveport, Shreveport, LA, USA.
Aims:
Multiple myeloma accounts for over 10-15% of haematological malignancies. Continued molecular advances have resulted in the development of new drugs for treatment of multiple myeloma. Four drugs were approved by the Food and Drug Administration (FDA) in 2015, but their safety is not well defined. The aim of this study is to delineate the cardiovascular adverse events of these drugs.
Methods:
We reviewed the adverse cardiac events of newly approved FDA drugs since 2015 using the US FDA Adverse Events Reporting System (FAERS) database. We calculated the reporting odds ratio (ROR) with 95% confidence interval (CIs) for the drugs that have the highest incidence of cardiovascular adverse events.
Results:
Among the medications that have approved for multiple myeloma between 2015 and 2020, 4 novel drugs showed the highest incidence of cardiotoxicity. ROR (95% CI) for atrial fibrillation due to elotuzumab, ixazomib, daratumumab and panobinostat compared to other FAERS drugs was 5.8 (4.4-7.7), 1.9 (1.5-2.3), 4.8 (4.2-5.6) and 5.7 (4.1-8.1), respectively. The ROR (95% CI) for cardiac failure was 8.2 (6.4-10.5), 4.7 (4.1-5.4), 5.8 (4.9-6.7) and 5.6 (3.8-8.1) and ROR (95% CI) for coronary disease was 2.7 (1.9-3.9), 2.7 (2.3-3.2), 2.3 (1.9-2.8) and 4.6 (3.2-6.6) due to elotuzumab, ixazomib, daratumumab and panobinostat compared to all other drugs in FAERS.
Conclusion:
Our results demonstrated that certain newly approved antimyeloma therapies are significantly associated with previously unknown cardiotoxicity. These results warrant further studies and highlight the importance of considering the cardiac history of patients with multiple myeloma when utilizing these novel agents.
Insights
Newly approved multiple myeloma drugs show significant cardiotoxicity risks, including atrial fibrillation and cardiac failure. Healthcare providers should consider patient cardiac history when prescribing these novel therapies.
Area of Science:
- Cardiology and Hematology
- Pharmacovigilance
- Oncology
Background:
- Multiple myeloma is a significant hematological malignancy with evolving treatment landscapes.
- Recent advancements have led to new drug approvals for multiple myeloma, necessitating safety evaluations.
- The cardiovascular safety of novel drugs approved since 2015 requires thorough investigation.
Approach:
- Utilized the US Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) database.
- Analyzed cardiovascular adverse events associated with newly approved multiple myeloma drugs.
- Calculated Reporting Odds Ratios (ROR) with 95% Confidence Intervals (CIs) to assess cardiotoxicity risks.
Key Points:
- Four novel drugs approved for multiple myeloma between 2015-2020 exhibited the highest incidence of cardiotoxicity.
- Significant RORs were observed for atrial fibrillation, cardiac failure, and coronary disease associated with elotuzumab, ixazomib, daratumumab, and panobinostat.
- Elotuzumab and panobinostat showed particularly high RORs for cardiac failure and atrial fibrillation.
Conclusions:
- Newly approved antimyeloma therapies are linked to significant, previously unrecognized cardiotoxicity.
- These findings underscore the importance of evaluating patients' cardiac history before initiating treatment with these novel agents.
- Further research is warranted to fully elucidate the cardiovascular risks associated with these drugs.
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