論文

査読有り 国際誌
2017年7月

Thromboembolic adverse event study of combined estrogen-progestin preparations using Japanese Adverse Drug Event Report database

PLOS ONE
  • Shiori Hasegawa
  • ,
  • Toshinobu Matsui
  • ,
  • Yuuki Hane
  • ,
  • Junko Abe
  • ,
  • Haruna Hatahira
  • ,
  • Yumi Motooka
  • ,
  • Sayaka Sasaoka
  • ,
  • Akiho Fukuda
  • ,
  • Misa Naganuma
  • ,
  • Kouseki Hirade
  • ,
  • Yukiko Takahashi
  • ,
  • Yasutomi Kinosada
  • ,
  • Mitsuhiro Nakamura

12
7
開始ページ
e0182045
終了ページ
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1371/journal.pone.0182045
出版者・発行元
PUBLIC LIBRARY SCIENCE

Combined estrogen-progestin preparations (CEPs) are associated with thromboembolic (TE) side effects. The aim of this study was to evaluate the incidence of TE using the Japanese Adverse Drug Event Report (JADER) database. Adverse events recorded from April 2004 to November 2014 in the JADER database were obtained from the Pharmaceuticals and Medical Devices Agency (PMDA) website (www.pmda.go.jp). We calculated the reporting odds ratios (RORs) of suspected CEPs, analyzed the time-to-onset profile, and assessed the hazard type using Weibull shape parameter (WSP). Furthermore, we used the applied association rule mining technique to discover undetected relationships such as the possible risk factors. The total number of reported cases in the JADER contained was 338,224. The RORs (95% confidential interval, CI) of drospirenone combined with ethinyl estradiol (EE, Dro-EE), norethisterone with EE (Ne-EE), levonorgestrel with EE (Lev-EE), desogestrel with EE (Des-EE), and norgestrel with EE (Nor-EE) were 56.2 (44.3-71.4), 29.1 (23.5-35.9), 42.9 (32.3-57.0), 44.7 (32.7-61.1), and 38.6 (26.3-56.7), respectively. The medians (25%-75%) of the time-to-onset of Dro-EE, Ne-EE, Lev-EE, Des-EE, and Nor-EE were 150.0 (75.3-314.0), 128.0 (27.0-279.0), 204.0 (44.0-660.0), 142.0 (41.3-344.0), and 16.5 (8.8-32.0) days, respectively. The 95% CIs of the WSP-beta for Ne-EE, Lev-EE, and Nor-EE were lower and excluded 1. Association rule mining indicated that patients with anemia had a potential risk of developing a TE when using CEPs. Our results suggest that it is important to monitor patients administered CEP for TE. Careful observation is recommended, especially for those using Nor-EE, and this information may be useful for efficient therapeutic planning.

Web of Science ® 被引用回数 : 6

リンク情報
DOI
https://doi.org/10.1371/journal.pone.0182045
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/28732067
PubMed Central
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5521832
Web of Science
https://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=JSTA_CEL&SrcApp=J_Gate_JST&DestLinkType=FullRecord&KeyUT=WOS:000406643100074&DestApp=WOS_CPL

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