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Adverse Reaction Profiles Related to Gastrointestinal Bleeding Events Associated with BCR-ABL Tyrosine Kinase Inhibitors

Background and Objectives: The aim of this study is to investigate the characteristics of gastrointestinal bleeding events associated with BCR-ABL tyrosine kinase inhibitor (TKI) treatment, using the reporting odds ratio (ROR) of the adverse event reports submitted to the Japanese Adverse Drug Event...

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Autores principales: Kawada, Kei, Ishida, Tomoaki, Jobu, Kohei, Morisawa, Shumpei, Tamura, Naohisa, Sugimoto, Shouhei, Okazaki, Masafumi, Yoshioka, Saburo, Miyamura, Mitsuhiko
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9609656/
https://www.ncbi.nlm.nih.gov/pubmed/36295654
http://dx.doi.org/10.3390/medicina58101495
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author Kawada, Kei
Ishida, Tomoaki
Jobu, Kohei
Morisawa, Shumpei
Tamura, Naohisa
Sugimoto, Shouhei
Okazaki, Masafumi
Yoshioka, Saburo
Miyamura, Mitsuhiko
author_facet Kawada, Kei
Ishida, Tomoaki
Jobu, Kohei
Morisawa, Shumpei
Tamura, Naohisa
Sugimoto, Shouhei
Okazaki, Masafumi
Yoshioka, Saburo
Miyamura, Mitsuhiko
author_sort Kawada, Kei
collection PubMed
description Background and Objectives: The aim of this study is to investigate the characteristics of gastrointestinal bleeding events associated with BCR-ABL tyrosine kinase inhibitor (TKI) treatment, using the reporting odds ratio (ROR) of the adverse event reports submitted to the Japanese Adverse Drug Event Report database between 2004 and 2020, and to examine the number of reported TKI-related gastrointestinal bleeding cases according to sex and age, as well as the actual number of TKI prescriptions issued in Japan. Materials and Methods: The RORs and 95% confidence intervals (CIs) of gastrointestinal bleeding events related to TKIs were calculated using the data of the 595,121 included cases. Results: Significant gastrointestinal bleeding events were detected for dasatinib (crude ROR: 4.47, 95% CI: 3.77–5.28) and imatinib (crude ROR: 1.22, 95% CI: 1.01–1.46). In multiple logistic regression analyses, significant gastrointestinal bleeding events were detected for dasatinib (adjusted ROR: 8.02, 95% CI: 5.75–10.2), imatinib (adjusted ROR: 1.81, 95% CI: 1.2–2.72), age (≥60 years, adjusted ROR: 2.22, 95% CI: 2.1–2.36), reporting year (adjusted ROR: 1.04, 95% CI: 1.04–1.05), and male sex (adjusted ROR: 1.47, 95% CI: 1.37–1.57). Interaction analysis revealed that the association of gastrointestinal bleeding with dasatinib was affected by age (≥60 years) and sex (female), with the number and proportion of dasatinib-related gastrointestinal bleeding cases increasing among those aged ≥60 years. Conclusions: Specific TKIs and patient characteristics were associated with gastrointestinal bleeding. Our results aid the prompt identification and treatment of TKI-related gastrointestinal bleeding.
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spelling pubmed-96096562022-10-28 Adverse Reaction Profiles Related to Gastrointestinal Bleeding Events Associated with BCR-ABL Tyrosine Kinase Inhibitors Kawada, Kei Ishida, Tomoaki Jobu, Kohei Morisawa, Shumpei Tamura, Naohisa Sugimoto, Shouhei Okazaki, Masafumi Yoshioka, Saburo Miyamura, Mitsuhiko Medicina (Kaunas) Article Background and Objectives: The aim of this study is to investigate the characteristics of gastrointestinal bleeding events associated with BCR-ABL tyrosine kinase inhibitor (TKI) treatment, using the reporting odds ratio (ROR) of the adverse event reports submitted to the Japanese Adverse Drug Event Report database between 2004 and 2020, and to examine the number of reported TKI-related gastrointestinal bleeding cases according to sex and age, as well as the actual number of TKI prescriptions issued in Japan. Materials and Methods: The RORs and 95% confidence intervals (CIs) of gastrointestinal bleeding events related to TKIs were calculated using the data of the 595,121 included cases. Results: Significant gastrointestinal bleeding events were detected for dasatinib (crude ROR: 4.47, 95% CI: 3.77–5.28) and imatinib (crude ROR: 1.22, 95% CI: 1.01–1.46). In multiple logistic regression analyses, significant gastrointestinal bleeding events were detected for dasatinib (adjusted ROR: 8.02, 95% CI: 5.75–10.2), imatinib (adjusted ROR: 1.81, 95% CI: 1.2–2.72), age (≥60 years, adjusted ROR: 2.22, 95% CI: 2.1–2.36), reporting year (adjusted ROR: 1.04, 95% CI: 1.04–1.05), and male sex (adjusted ROR: 1.47, 95% CI: 1.37–1.57). Interaction analysis revealed that the association of gastrointestinal bleeding with dasatinib was affected by age (≥60 years) and sex (female), with the number and proportion of dasatinib-related gastrointestinal bleeding cases increasing among those aged ≥60 years. Conclusions: Specific TKIs and patient characteristics were associated with gastrointestinal bleeding. Our results aid the prompt identification and treatment of TKI-related gastrointestinal bleeding. MDPI 2022-10-20 /pmc/articles/PMC9609656/ /pubmed/36295654 http://dx.doi.org/10.3390/medicina58101495 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Kawada, Kei
Ishida, Tomoaki
Jobu, Kohei
Morisawa, Shumpei
Tamura, Naohisa
Sugimoto, Shouhei
Okazaki, Masafumi
Yoshioka, Saburo
Miyamura, Mitsuhiko
Adverse Reaction Profiles Related to Gastrointestinal Bleeding Events Associated with BCR-ABL Tyrosine Kinase Inhibitors
title Adverse Reaction Profiles Related to Gastrointestinal Bleeding Events Associated with BCR-ABL Tyrosine Kinase Inhibitors
title_full Adverse Reaction Profiles Related to Gastrointestinal Bleeding Events Associated with BCR-ABL Tyrosine Kinase Inhibitors
title_fullStr Adverse Reaction Profiles Related to Gastrointestinal Bleeding Events Associated with BCR-ABL Tyrosine Kinase Inhibitors
title_full_unstemmed Adverse Reaction Profiles Related to Gastrointestinal Bleeding Events Associated with BCR-ABL Tyrosine Kinase Inhibitors
title_short Adverse Reaction Profiles Related to Gastrointestinal Bleeding Events Associated with BCR-ABL Tyrosine Kinase Inhibitors
title_sort adverse reaction profiles related to gastrointestinal bleeding events associated with bcr-abl tyrosine kinase inhibitors
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9609656/
https://www.ncbi.nlm.nih.gov/pubmed/36295654
http://dx.doi.org/10.3390/medicina58101495
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