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Pharmacovigilance analysis of cardiac risks associated with Bruton tyrosine kinase inhibitors
Clinical Research Center, School of Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai JiaoTong University, Shanghai 00011, China.
Department of Medical Service, Naval Hospital of Eastern theater, Zhejiang, Zhoushan 316000, China; Department of Health Statistics, Second Military Medical University, Shanghai 200433, China.
Clinical Research Center, School of Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai JiaoTong University, Shanghai 00011, China; Department of Health Statistics, Second Military Medical University, Shanghai 200433, China.
Department of Health Statistics, Second Military Medical University, Shanghai 200433, China.
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2023 (English)In: Expert Opinion on Drug Safety, ISSN 1474-0338, E-ISSN 1744-764X, Vol. 22, no 9, p. 857-869Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Bruton tyrosine kinase inhibitors (BTKIs) can be associated with several cardiac risks.

RESEARCH DESIGN AND METHODS: This study was conducted based on records from a large spontaneous reporting database, the Food and Drug Administration Adverse Event Reporting System, for cardiac events reported for several BTKI agents. Reporting odds ratio and information components based on statistical shrinkage transformation were utilized to measure disproportionality.

RESULTS: The final number of records for BTKI-related cardiac events was 10 320. Death or life-threatening events occurred in 17.63% of all associated cardiac records. Significant reporting was captured between BTKI (total/specific) and cardiac events, with the strongest association for ibrutinib. A total of 47 positive signals were evacuated for ibrutinib, with atrial fibrillation being the most commonly reported one. Concomitantly, cardiac failure congestive, cardiac disorder, arrhythmia, pericardial effusion, and atrial flutter, were also noticed for relatively stronger signal and disproportionality. Atrial fibrillation was over-reported in the 3 groups (ibrutinib, acalabrutinib, zanubrutinib), and acalabrutinib had statistically significant lower reporting compared with ibrutinib.

CONCLUSIONS: Receiving ibrutinib, acalabrutinib or zanubrutinib might increase the chance of cardiac complications, with ibrutinib posing the highest risk. The type of cardiotoxicity involved in ibrutinib was highly variable.

Place, publisher, year, edition, pages
Ashley Mark Publishing Company , 2023. Vol. 22, no 9, p. 857-869
Keywords [en]
Bruton tyrosine kinase inhibitors, FAERS database, acalabrutinib, cardiac safety, disproportionality analysis, ibrutinib, zanubrutinib
National Category
Cardiac and Cardiovascular Systems
Identifiers
URN: urn:nbn:se:oru:diva-105597DOI: 10.1080/14740338.2023.2204226ISI: 000972365100001PubMedID: 37070462Scopus ID: 2-s2.0-85153476513OAI: oai:DiVA.org:oru-105597DiVA, id: diva2:1751667
Note

Funding agencies:

National Natural Science Foundation of China (NSFC) 82073671

Leading Talents of Public Health in Shanghai GWV-10.2-XD22

Shanghai Municipal Commission of Health and Family Planning Fund for Excellent Young Scholars 2018YQ47

Excellent Young Scholars of Public Health in Shanghai GWV-10.2-YQ33

Three-year Action Program of Shanghai Municipality for Strengthening the Construction of Public Health System GWV-10.1-XK05

Military Key Discipline Construction Project (Health Service-Naval Health Service Organization and Command) 03

Medical and Health Project of Zhoushan Municipal Health Commission 2022JYB05

Available from: 2023-04-19 Created: 2023-04-19 Last updated: 2023-10-16Bibliographically approved

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Cao, Yang

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