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. 2023 Jan 9;16(1):98.
doi: 10.3390/ph16010098.

Cardiovascular Toxicities of Ibrutinib: A Pharmacovigilance Study Based on the United States Food and Drug Administration Adverse Event Reporting System Database

Yi Zheng  1 , Xiaojing Guo  1 , Chenxin Chen  1 , Lijie Chi  1 , Zhijian Guo  1 , Jizhou Liang  1 , Lianhui Wei  1 , Xiao Chen  1 , Xiaofei Ye  1 , Jia He  1
Affiliations

Cardiovascular Toxicities of Ibrutinib: A Pharmacovigilance Study Based on the United States Food and Drug Administration Adverse Event Reporting System Database

Yi Zheng et al. Pharmaceuticals (Basel). .

Abstract

Background: Although ibrutinib has been widely used to treat haematological malignancies, many studies have reported associated cardiovascular events. These studies were primarily animal experiments and clinical trials. For more rational clinical drug use, a study based on post-marketing data is necessary. Aim: Based on post-marketing data, we investigated the clinical features, time to onset, and outcomes of potential cardiovascular toxicities of ibrutinib. Methods: This disproportionality study utilised data from the 2014−2021 United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. We used two disproportionality methods information component (IC) and reporting odds ratio (ROR)) to detect the potential cardiovascular toxicities of ibrutinib. Positive signals were defined as IC025 > 0 and ROR025 > 1. Results: A total of 10 cardiovascular events showed positive signals: supraventricular tachyarrhythmias, haemorrhagic central nervous system vascular conditions, ventricular tachyarrhythmias, cardiac failure, ischaemic central nervous system vascular conditions, cardiomyopathy, conduction defects, myocardial infarction, myocardial infarction disorders of sinus node function, and torsade de pointes/QT prolongation. Cardiomyopathy and supraventricular tachyarrhythmias were the two most common signals. Disorders of sinus node function were observed for the first time, which may be a new adverse effect of ibrutinib. Conclusions: This pharmacovigilance study systematically explored the adverse cardiovascular events of ibrutinib and provided new safety signals based on past safety information. Attention should be paid to some high-risk signals.

Keywords: FAERS; cardiovascular events; disproportionality analysis; ibrutinib; pharmacovigilance study.

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Conflict of interest statement

We confirm that the authors have no relevant affiliations or financial involvement with any organisation or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Figures

Figure 1
Figure 1
Information component (IC) and its 95% CI over time for 10 signals.
Figure 2
Figure 2
The signals in preferred terms (PTs) associated with cardiovascular toxicities.
Figure 3
Figure 3
Time to onset for 10 cardiovascular toxicities.
See this image and copyright information in PMC

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