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  1. 教員研究業績
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Signal Detection Study Focusing on Differences in the Drug Delivery System of Oral 5-Aminosalicylate for Inflammatory Bowel Disease Using the Japanese Pharmacovigilance Database

https://gifu-pu.repo.nii.ac.jp/records/14845
https://gifu-pu.repo.nii.ac.jp/records/14845
fe7ab875-257b-4ac5-a2e3-affec582e424
Item type 研究室原著論文(1)
公開日 2023-03-17
タイトル
タイトル Signal Detection Study Focusing on Differences in the Drug Delivery System of Oral 5-Aminosalicylate for Inflammatory Bowel Disease Using the Japanese Pharmacovigilance Database
言語 en
言語
言語 eng
キーワード
言語 en
主題Scheme Other
主題 5-Aminosalicylate
キーワード
言語 en
主題Scheme Other
主題 drug delivery systems
キーワード
言語 en
主題Scheme Other
主題 safety signal
キーワード
言語 en
主題Scheme Other
主題 disproportionality analysis
キーワード
言語 en
主題Scheme Other
主題 Japanese Ad-verse Drug Event Report database (JADER)
資源タイプ
資源タイプ識別子 http://purl.org/coar/resource_type/c_6501
資源タイプ journal article
アクセス権
アクセス権 metadata only access
アクセス権URI http://purl.org/coar/access_right/c_14cb
抄録
値 Although 5-Aminosalicylate (5-ASA) has been shown to act on the local mucosa, when 5-ASA is orally administered, most of it is absorbed in the upper gastrointestinal tract and does not reach the large intestine, where lesions are present. Therefore, different drug delivery systems have been developed for each oral 5-ASA formulation. Currently, the oral 5-ASA formulation approved in Japan is salazosulfapyridine (SALAZOPYRIN®; Pfizer Japan Inc.: Tokyo, Japan), in which 5-ASA and sulfapyridine are azo-bonded. In addition, there are several 5-ASA release formulations, including ASACOL®; ZERIA Pharmaceutical Co., Ltd.: Tokyo, Japan (delayed release formulation dependent on pH), PENTASA®; KYORIN Pharmaceutical Co., Ltd.: Tokyo, Japan (delayed release formulation dependent on time), and LIALDA®; MOCHIDA Pharmaceutical Co., Ltd.: Tokyo, Japan (delayed release formulation dependent on pH and time). Adverse events may occur because of differences in the drug delivery systems of these products. In this study, we focused on the adverse events of different 5-ASA formulations and investigated differences in the detection of safety signals for each 5-ASA formulation using disproportionality analysis. There were 15 adverse events detected only with SALAZOPYRIN®. On the other hand, ASACOL®, PENTASA®, and LIALDA® have different drug delivery systems. Although the detected signal intensities varied, the detected adverse events were not significantly different. These findings provide important insights, which should be considered by physicians during treatment selection and drug manufacturers during drug development.
書誌情報 en : Pharmacoepidemiology

巻 2, 号 1, p. 26-34, 発行日 2023
DOI
値 https://doi.org/10.3390/pharma2010003
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