Cardiovascular Complications of Modern Multiple Myeloma Therapy: A
Pharmacovigilance Study
Abstract
Background: Multiple myeloma accounts for over 15% of hematological
malignancies. In attempt to tackle this malady, the FDA approved four
drugs in 2015 which has propagated further development of new
anti-multiple myeloma since. However, the health safety of these new
agents is still ill-defined. The aim of this study is to delineate the
cardiovascular adverse events of these drugs. Methods: We searched the
cardiac adverse events of the newly approved FDA drugs since 2015 using
the U.S. Food and Drug Administration Adverse Events Reporting System
database (FAERS). We calculated the reporting odds ratio (ROR) with 95%
confidence for four drugs that have the highest incidence of
cardiovascular adverse events. Results: Among the medications that have
approved for MM Between 2015-2020, four 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 versus all other drugs in FAERS. Conclusions: Our
results demonstrated that the newly approved antimyeloma therapy
(elotuzumab, Ixazomib, daratumumab, panobinostat) are significantly
associated previously unknow 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.