Analysis of ventricular arrhythmias and sudden death from prospective, randomized clinical trials of acalabrutinib
- Author(s)
- Sharman, JP; Ghia, P; Miranda, P; Bajwa, N; Rule, S; Shaw, B; Seymour, JF;
- 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
- Publisher's Version
- https://doi.org/10.1111/bjh.19469
- 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.
Creation Date: 2024-09-19 04:52:47
Last Modified: 2024-09-19 04:57:10