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Low body surface area predicts hepatotoxicity of nintedanib in patients with idiopathic pulmonary fibrosis

After the commercialization of nintedanib in Japan, a high incidence of hepatotoxicity resulting in treatment interruption was noted in idiopathic pulmonary fibrosis (IPF) patients treated with nintedanib in our hospital. This study aimed to clarify the risk factors for hepatotoxicity of nintedanib....

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Autores principales: Ikeda, Satoshi, Sekine, Akimasa, Baba, Tomohisa, Yamanaka, Yumie, Sadoyama, Shinko, Yamakawa, Hideaki, Oda, Tsuneyuki, Okuda, Ryo, Kitamura, Hideya, Okudela, Koji, Iwasawa, Tae, Ohashi, Kenichi, Takemura, Tamiko, Ogura, Takashi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5589740/
https://www.ncbi.nlm.nih.gov/pubmed/28883482
http://dx.doi.org/10.1038/s41598-017-11321-x
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author Ikeda, Satoshi
Sekine, Akimasa
Baba, Tomohisa
Yamanaka, Yumie
Sadoyama, Shinko
Yamakawa, Hideaki
Oda, Tsuneyuki
Okuda, Ryo
Kitamura, Hideya
Okudela, Koji
Iwasawa, Tae
Ohashi, Kenichi
Takemura, Tamiko
Ogura, Takashi
author_facet Ikeda, Satoshi
Sekine, Akimasa
Baba, Tomohisa
Yamanaka, Yumie
Sadoyama, Shinko
Yamakawa, Hideaki
Oda, Tsuneyuki
Okuda, Ryo
Kitamura, Hideya
Okudela, Koji
Iwasawa, Tae
Ohashi, Kenichi
Takemura, Tamiko
Ogura, Takashi
author_sort Ikeda, Satoshi
collection PubMed
description After the commercialization of nintedanib in Japan, a high incidence of hepatotoxicity resulting in treatment interruption was noted in idiopathic pulmonary fibrosis (IPF) patients treated with nintedanib in our hospital. This study aimed to clarify the risk factors for hepatotoxicity of nintedanib. Sixty-eight consecutive cases of IPF newly treated with nintedanib at a dose of 150 mg twice daily from September 2015 to September 2016 were enrolled: 46 patients (67.6%) exhibited aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) elevation and 16 patients (23.5%) also had a Common Terminology Criteria for Adverse Events (CTCAE) grade ≥2. Body surface area (BSA) was significantly lower in the CTCAE grade ≥2 group than in another group. A multivariate logistic regression analysis showed that the association between BSA and AST/ALT elevation with CTCAE grade ≥2 was statistically significant. Eight of 10 patients who resumed nintedanib at a reduced dose of 100 mg twice daily after interruption due to hepatotoxicity did not again develop AST/ALT elevation. In conclusion, a low BSA was associated with hepatotoxicity of nintedanib at a dose of 150 mg twice daily. It would be a good option for patients with a small physique to start nintedanib at a dose of 100 mg twice daily and then increase if possible after confirming its safety.
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spelling pubmed-55897402017-09-13 Low body surface area predicts hepatotoxicity of nintedanib in patients with idiopathic pulmonary fibrosis Ikeda, Satoshi Sekine, Akimasa Baba, Tomohisa Yamanaka, Yumie Sadoyama, Shinko Yamakawa, Hideaki Oda, Tsuneyuki Okuda, Ryo Kitamura, Hideya Okudela, Koji Iwasawa, Tae Ohashi, Kenichi Takemura, Tamiko Ogura, Takashi Sci Rep Article After the commercialization of nintedanib in Japan, a high incidence of hepatotoxicity resulting in treatment interruption was noted in idiopathic pulmonary fibrosis (IPF) patients treated with nintedanib in our hospital. This study aimed to clarify the risk factors for hepatotoxicity of nintedanib. Sixty-eight consecutive cases of IPF newly treated with nintedanib at a dose of 150 mg twice daily from September 2015 to September 2016 were enrolled: 46 patients (67.6%) exhibited aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) elevation and 16 patients (23.5%) also had a Common Terminology Criteria for Adverse Events (CTCAE) grade ≥2. Body surface area (BSA) was significantly lower in the CTCAE grade ≥2 group than in another group. A multivariate logistic regression analysis showed that the association between BSA and AST/ALT elevation with CTCAE grade ≥2 was statistically significant. Eight of 10 patients who resumed nintedanib at a reduced dose of 100 mg twice daily after interruption due to hepatotoxicity did not again develop AST/ALT elevation. In conclusion, a low BSA was associated with hepatotoxicity of nintedanib at a dose of 150 mg twice daily. It would be a good option for patients with a small physique to start nintedanib at a dose of 100 mg twice daily and then increase if possible after confirming its safety. Nature Publishing Group UK 2017-09-07 /pmc/articles/PMC5589740/ /pubmed/28883482 http://dx.doi.org/10.1038/s41598-017-11321-x Text en © The Author(s) 2017 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Article
Ikeda, Satoshi
Sekine, Akimasa
Baba, Tomohisa
Yamanaka, Yumie
Sadoyama, Shinko
Yamakawa, Hideaki
Oda, Tsuneyuki
Okuda, Ryo
Kitamura, Hideya
Okudela, Koji
Iwasawa, Tae
Ohashi, Kenichi
Takemura, Tamiko
Ogura, Takashi
Low body surface area predicts hepatotoxicity of nintedanib in patients with idiopathic pulmonary fibrosis
title Low body surface area predicts hepatotoxicity of nintedanib in patients with idiopathic pulmonary fibrosis
title_full Low body surface area predicts hepatotoxicity of nintedanib in patients with idiopathic pulmonary fibrosis
title_fullStr Low body surface area predicts hepatotoxicity of nintedanib in patients with idiopathic pulmonary fibrosis
title_full_unstemmed Low body surface area predicts hepatotoxicity of nintedanib in patients with idiopathic pulmonary fibrosis
title_short Low body surface area predicts hepatotoxicity of nintedanib in patients with idiopathic pulmonary fibrosis
title_sort low body surface area predicts hepatotoxicity of nintedanib in patients with idiopathic pulmonary fibrosis
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5589740/
https://www.ncbi.nlm.nih.gov/pubmed/28883482
http://dx.doi.org/10.1038/s41598-017-11321-x
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