Cardiovascular Toxicity of Tyrosine Kinase Inhibitors Used in Chronic Myeloid Leukemia: An Analysis of the FDA Adverse Event Reporting System Database (FAERS)

Tyrosine kinase inhibitors (TKIs), the treatment of choice for chronic myeloid leukemia (CML), can be associated to cardiovascular (CV) adverse events (AEs). A case/non-case study was performed using AE reports registered in the Food and Drug Administration (FDA) Adverse Event Reporting System (FAER...

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Bibliographic Details
Published in:Cancers 2020-03, Vol.12 (4), p.826
Main Authors: Cirmi, Santa, El Abd, Asmae, Letinier, Louis, Navarra, Michele, Salvo, Francesco
Format: Article
Language:English
Subjects:
Cancer
Cardiac arrhythmia
Cardiovascular disease
Chromosomes
Chronic myeloid leukemia
Coronary artery disease
Drugs
FDA approval
Heart diseases
Hypertension
Imatinib
Ischemia
Kinases
Leukemia
Medical prognosis
Myeloid leukemia
Patients
Pharmaceutical industry
Pulmonary hypertension
Toxicity
Tyrosine kinase inhibitors
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Summary:Tyrosine kinase inhibitors (TKIs), the treatment of choice for chronic myeloid leukemia (CML), can be associated to cardiovascular (CV) adverse events (AEs). A case/non-case study was performed using AE reports registered in the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to compare the risk of CV event reports related to TKIs indicated in the management of chronic myeloid leukemia (CML). Disproportionality of CV event-related TKIs was computed using the Reporting Odds Ratio (ROR) as a measure of potential risk increase. Nilotinib accounts for more than half of reported cases related to TKIs. Signal of Disproportionate Reporting (SDR) was found for cardiac failure, ischemic heart disease, cardiac arrhythmias, /QT prolongation, hypertension, and pulmonary hypertension. Dasatinib and bosutinib were related to the highest disproportionality for cardiac failure. Nilotinib was associated with the highest SDR for ischemic heart disease, /QT prolongation and cardiac arrhythmias. Only ponatinib was related to an SDR for hypertension, while dasatinib and imatinib were related to pulmonary hypertension. In the context of CML, TKIs have different safety profiles related to CV events, among which nilotinib seems particularly related to. These results claim for a revision of its CV safety profile mainly for the risk of /QT prolongation.
ISSN:2072-6694
2072-6694
DOI:10.3390/cancers12040826