| Item type |
文献 / Documents(1) |
| 公開日 |
2020-10-27 |
| 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 |
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|
関連識別子 |
https://doi.org/10.1002/cam4.1920 |
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|
関連名称 |
10.1002/cam4.1920 |
| 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 |
Pharmacovigilance evaluation of the relationship between impaired glucose metabolism and BCR‐ABL inhibitor use by using an adverse drug event reporting database |
| 著者 |
岡田, 直人
新村, 貴博
座間味, 義人
濱野, 裕章
イシダ, シュンスケ
合田, 光寛
武智, 研志
中馬, 真幸
今西, 正樹
石澤, 啓介
|
| 抄録 |
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内容記述 |
Breakpoint cluster region‐Abelson murine leukemia (BCR‐ABL) inhibitors markedly improve the prognosis of chronic myeloid leukemia. However, high treatment adherence is necessary for successful treatment with BCR‐ABL inhibitors. Therefore, an adequate understanding of the adverse event profiles of BCR‐ABL inhibitors is essential. Although many adverse events are observed in trials, an accurate identification of adverse events based only on clinical trial results is difficult because of strict entry criteria or limited follow‐up durations. In particular, BCR‐ABL inhibitor‐induced impaired glucose metabolism remains controversial. Pharmacovigilance evaluations using spontaneous reporting systems are useful for analyzing drug‐related adverse events in clinical settings. Therefore, we conducted signal detection analyses for BCR‐ABL inhibitor‐induced impaired glucose metabolism by using the FDA Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) database. Signals for an increased reporting rate of impaired glucose metabolism were detected only for nilotinib use, whereas these signals were not detected for other BCR‐ABL inhibitors. Subgroup analyses showed a clearly increased nilotinib‐associated reporting rate of impaired glucose metabolism in male and younger patients. Although FAERS‐ and JADER‐based signal detection analyses cannot determine causality perfectly, our study suggests the effects on glucose metabolism are different between BCR‐ABL inhibitors and provides useful information for the selection of appropriate BCR‐ABL inhibitors. |
| キーワード |
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|
主題 |
BCR‐ABL inhibitors |
| キーワード |
|
|
主題 |
FAERS |
| キーワード |
|
|
主題 |
impaired glucose metabolism |
| キーワード |
|
|
主題 |
JADER |
| キーワード |
|
|
主題 |
spontaneous reporting system |
| 書誌情報 |
en : Cancer Medicine
巻 8,
号 1,
p. 174-181,
発行日 2018-12-18
|
| 収録物ID |
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|
収録物識別子タイプ |
ISSN |
|
収録物識別子 |
20457634 |
| 出版者 |
|
|
出版者 |
John Wiley & Sons |
| 権利情報 |
|
|
権利情報 |
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
| EID |
|
|
識別子 |
348788 |
| 言語 |
|
|
言語 |
eng |
cam_8_1_174.pdf (191 KB)
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