Key result
Ibrutinib is linked to a ~23-fold higher reporting of supraventricular arrhythmias.
Why the study?
Cardiovascular toxicities were suspected to contribute to increased mortality with ibrutinib in a front-line setting but were not directly assessed.
Is ibrutinib associated with increased cardiovascular adverse drug reactions and deaths compared to other drugs in a pharmacovigilance database?
Observational
Yes
Is ibrutinib associated with increased cardiovascular adverse drug reactions and deaths compared to other drugs in a pharmacovigilance database?
Answers are grounded in this paper and cite their sources.
Ibrutinib is associated with severe and occasionally fatal cardiovascular toxicities, particularly supraventricular arrhythmias, highlighting the need for cardiovascular monitoring in treated patients.
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Salem et al. (2019) conducted an observational in B-cell malignancies. Ibrutinib vs. Expected reporting values (background database) was evaluated on Reporting of supraventricular arrhythmias (SVAs) (ROR 23.1, 95% CI 21.6 to 24.7, p=<0.0001). Ibrutinib exposure was associated with higher reporting of supraventricular arrhythmias and 303 cardiovascular deaths.
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