Analysis of ventricular arrhythmias and sudden death from prospective, randomized clinical trials of acalabrutinib
Details
Publication Year 2024-08,Volume 205,Issue #2,Page 529-533
Journal Title
British Journal of Haematology
Publication Type
Research article
Abstract
This analysis investigated the incidence of sudden deaths (SDs) and non-fatal and fatal ventricular arrhythmias (VAs) in five acalabrutinib clinical trials. In total, 1299 patients received acalabrutinib (exposure, 4568.4 patient-years). Sixteen (1.2%) patients experienced SD or VA (event rate, 0.350/100 patient-years). Non-fatal VAs occurred in 11 (0.8%) patients, nine (0.7%) of whom had premature ventricular contractions only. SD and fatal VAs occurred in five (0.4%) patients (event rate, 0.109/100 patient-years; median time to event: 46.2 months). SDs and VAs with acalabrutinib occurred at low rates, and there are insufficient data to point to an increased risk of SD or VA with acalabrutinib.
Publisher
Wiley
Keywords
Humans; *Benzamides/adverse effects/therapeutic use; *Pyrazines/adverse effects/therapeutic use/administration & dosage; Male; Female; *Randomized Controlled Trials as Topic; Arrhythmias, Cardiac/chemically induced/mortality; Prospective Studies; Middle Aged; Aged; Death, Sudden/etiology/epidemiology; Death, Sudden, Cardiac/etiology/epidemiology; Adult; Incidence; acalabrutinib; ibrutinib; sudden cardiac death; sudden death; ventricular arrhythmia
Department(s)
Clinical Haematology
Open Access at Publisher's Site
https://doi.org/10.1111/bjh.19469
Terms of Use/Rights Notice
Refer to copyright notice on published article.


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Last Modified: 2024-09-19 04:57:10

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