論文

査読有り 国際誌
2019年1月

Pharmacovigilance evaluation of the relationship between impaired glucose metabolism and BCR-ABL inhibitor use by using an adverse drug event reporting database.

Cancer medicine
  • Naoto Okada
  • ,
  • Takahiro Niimura
  • ,
  • Yoshito Zamami
  • ,
  • Hirofumi Hamano
  • ,
  • Shunsuke Ishida
  • ,
  • Mitsuhiro Goda
  • ,
  • Kenshi Takechi
  • ,
  • Masayuki Chuma
  • ,
  • Masaki Imanishi
  • ,
  • Keisuke Ishizawa

8
1
開始ページ
174
終了ページ
181
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1002/cam4.1920

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.

リンク情報
DOI
https://doi.org/10.1002/cam4.1920
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/30561126
PubMed Central
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6346261
ID情報
  • DOI : 10.1002/cam4.1920
  • PubMed ID : 30561126
  • PubMed Central 記事ID : PMC6346261

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