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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...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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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. |
format | Online Article Text |
id | pubmed-9609656 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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