| Item type |
文献 / Documents(1) |
| 公開日 |
2024-07-11 |
| アクセス権 |
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|
アクセス権 |
open access |
| 資源タイプ |
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|
資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
|
資源タイプ |
journal article |
| 出版社版DOI |
|
|
|
関連識別子 |
https://doi.org/10.1016/j.resinv.2022.06.009 |
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|
関連名称 |
10.1016/j.resinv.2022.06.009 |
| 出版タイプ |
|
|
出版タイプ |
VoR |
|
出版タイプResource |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| タイトル |
|
|
タイトル |
Effects of nintedanib on disease progression and safety in Japanese patients with progressive fibrosing interstitial lung diseases : Further subset analysis from the whole INBUILD trial |
| 著者 |
オグラ, タカシ
スダ, タカフミ
イナセ, ナオヒコ
西岡, 安彦
アズマ, アラタ
オカモト, マサキ
タキザワ, アヤコ
イトウ, トモヒロ
Rohr, Klaus B.
イノウエ, ヨシカズ
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| 抄録 |
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|
内容記述 |
Background: A previous subgroup analysis of data from the INBUILD trial showed that nintedanib reduced the annual rate of decline in forced vital capacity (FVC) in Japanese patients with progressive fibrosing interstitial lung diseases (PF-ILDs). The safety profile of nintedanib over 52 weeks in Japanese patients was similar to that of the overall population.
Methods: Using data from 108 Japanese patients with PF-ILDs who had received at least 1 dose of study medication in the INBUILD trial, we evaluated the effect of nintedanib on disease progression and assessed the safety profile over the whole trial period (i.e., a longer duration than the prior analysis) compared with placebo. ILD progression was defined as an absolute decline in FVC ≥10% predicted vs baseline.
Results: Over the whole trial, in Japanese patients with PF-ILDs, nintedanib numerically lowered the risk of progression of ILD or death (hazard ratio [HR], 0.66; 95% confidence intervals [CI]: 0.37, 1.16), acute exacerbation of ILD or death (HR, 0.28; 95% CI: 0.09, 0.83), and death (HR, 0.41; 95% CI: 0.11, 1.51). The most common adverse event over the whole trial in nintedanib-treated Japanese patients was diarrhea, which was manageable for most patients by dose reduction and interruption. The safety profile of nintedanib in this longer duration analysis was consistent with that previously reported.
Conclusions: In this analysis of data from Japanese patients with PF-ILDs, nintedanib nominally reduced the risk of clinically meaningful outcomes reflecting disease progression, including death, over the whole trial, and no new safety concerns were observed. |
| キーワード |
|
|
主題 |
Nintedanib |
| キーワード |
|
|
主題 |
Progressive fibrosing interstitial |
| キーワード |
|
|
主題 |
lung disease |
| 書誌情報 |
en : Respiratory Investigation
巻 60,
号 6,
p. 787-797,
発行日 2022-08-01
|
| 収録物ID |
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収録物識別子タイプ |
ISSN |
|
収録物識別子 |
22125345 |
| 収録物ID |
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|
収録物識別子タイプ |
ISSN |
|
収録物識別子 |
22125353 |
| 収録物ID |
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|
収録物識別子タイプ |
NCID |
|
収録物識別子 |
AA12579673 |
| 収録物ID |
|
|
収録物識別子タイプ |
NCID |
|
収録物識別子 |
AA12797947 |
| 出版者 |
|
|
出版者 |
The Japanese Respiratory Society |
| 出版者 |
|
|
出版者 |
Elsevier |
| 権利情報 |
|
|
権利情報 |
This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). |
| EID |
|
|
識別子 |
396702 |
| 言語 |
|
|
言語 |
eng |
resinv_60_6_787.pdf (2.24 MB)
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