Signal Detection Study Focusing on Differences in the Drug Delivery System of Oral 5-Aminosalicylate for Inflammatory Bowel Disease Using the Japanese Pharmacovigilance Database

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 develope...

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Main Authors: Yoshihiro Noguchi, Shuji Yamashita, Hirofumi Tamaki, Arihiro Osanai, Yoko Ino, Tomoya Tachi, Kazuhiro Iguchi, Hitomi Teramachi
Format: Article
Language:English
Published: MDPI AG 2023-01-01
Series:Pharmacoepidemiology
Subjects:
Online Access:https://www.mdpi.com/2813-0618/2/1/3
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author Yoshihiro Noguchi
Shuji Yamashita
Hirofumi Tamaki
Arihiro Osanai
Yoko Ino
Tomoya Tachi
Kazuhiro Iguchi
Hitomi Teramachi
author_facet Yoshihiro Noguchi
Shuji Yamashita
Hirofumi Tamaki
Arihiro Osanai
Yoko Ino
Tomoya Tachi
Kazuhiro Iguchi
Hitomi Teramachi
author_sort Yoshihiro Noguchi
collection DOAJ
description 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<sup>®</sup>; 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<sup>®</sup>; ZERIA Pharmaceutical Co., Ltd.: Tokyo, Japan (delayed release formulation dependent on pH), PENTASA<sup>®</sup>; KYORIN Pharmaceutical Co., Ltd.: Tokyo, Japan (delayed release formulation dependent on time), and LIALDA<sup>®</sup>; 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<sup>®</sup>. On the other hand, ASACOL<sup>®</sup>, PENTASA<sup>®</sup>, and LIALDA<sup>®</sup> 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.
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spelling doaj.art-b9d94b0418624537bc9a1cb194974d702023-11-17T13:17:49ZengMDPI AGPharmacoepidemiology2813-06182023-01-0121263410.3390/pharma2010003Signal Detection Study Focusing on Differences in the Drug Delivery System of Oral 5-Aminosalicylate for Inflammatory Bowel Disease Using the Japanese Pharmacovigilance DatabaseYoshihiro Noguchi0Shuji Yamashita1Hirofumi Tamaki2Arihiro Osanai3Yoko Ino4Tomoya Tachi5Kazuhiro Iguchi6Hitomi Teramachi7Gifu Pharmaceutical University Community Pharmacy, 1-108-3, Daigakunishi, Gifu 501-1113, JapanGifu Pharmaceutical University Community Pharmacy, 1-108-3, Daigakunishi, Gifu 501-1113, JapanGifu Pharmaceutical University Community Pharmacy, 1-108-3, Daigakunishi, Gifu 501-1113, JapanGifu Pharmaceutical University Community Pharmacy, 1-108-3, Daigakunishi, Gifu 501-1113, JapanGifu Pharmaceutical University Community Pharmacy, 1-108-3, Daigakunishi, Gifu 501-1113, JapanLaboratory of Clinical Pharmacy, Gifu Pharmaceutical University, 1-25-4, Daigakunishi, Gifu 501-1196, JapanGifu Pharmaceutical University Community Pharmacy, 1-108-3, Daigakunishi, Gifu 501-1113, JapanGifu Pharmaceutical University Community Pharmacy, 1-108-3, Daigakunishi, Gifu 501-1113, JapanAlthough 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<sup>®</sup>; 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<sup>®</sup>; ZERIA Pharmaceutical Co., Ltd.: Tokyo, Japan (delayed release formulation dependent on pH), PENTASA<sup>®</sup>; KYORIN Pharmaceutical Co., Ltd.: Tokyo, Japan (delayed release formulation dependent on time), and LIALDA<sup>®</sup>; 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<sup>®</sup>. On the other hand, ASACOL<sup>®</sup>, PENTASA<sup>®</sup>, and LIALDA<sup>®</sup> 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.https://www.mdpi.com/2813-0618/2/1/35-Aminosalicylatedrug delivery systemssafety signaldisproportionality analysisJapanese Ad-verse Drug Event Report database (JADER)
spellingShingle Yoshihiro Noguchi
Shuji Yamashita
Hirofumi Tamaki
Arihiro Osanai
Yoko Ino
Tomoya Tachi
Kazuhiro Iguchi
Hitomi Teramachi
Signal Detection Study Focusing on Differences in the Drug Delivery System of Oral 5-Aminosalicylate for Inflammatory Bowel Disease Using the Japanese Pharmacovigilance Database
Pharmacoepidemiology
5-Aminosalicylate
drug delivery systems
safety signal
disproportionality analysis
Japanese Ad-verse Drug Event Report database (JADER)
title Signal Detection Study Focusing on Differences in the Drug Delivery System of Oral 5-Aminosalicylate for Inflammatory Bowel Disease Using the Japanese Pharmacovigilance Database
title_full Signal Detection Study Focusing on Differences in the Drug Delivery System of Oral 5-Aminosalicylate for Inflammatory Bowel Disease Using the Japanese Pharmacovigilance Database
title_fullStr Signal Detection Study Focusing on Differences in the Drug Delivery System of Oral 5-Aminosalicylate for Inflammatory Bowel Disease Using the Japanese Pharmacovigilance Database
title_full_unstemmed Signal Detection Study Focusing on Differences in the Drug Delivery System of Oral 5-Aminosalicylate for Inflammatory Bowel Disease Using the Japanese Pharmacovigilance Database
title_short Signal Detection Study Focusing on Differences in the Drug Delivery System of Oral 5-Aminosalicylate for Inflammatory Bowel Disease Using the Japanese Pharmacovigilance Database
title_sort signal detection study focusing on differences in the drug delivery system of oral 5 aminosalicylate for inflammatory bowel disease using the japanese pharmacovigilance database
topic 5-Aminosalicylate
drug delivery systems
safety signal
disproportionality analysis
Japanese Ad-verse Drug Event Report database (JADER)
url https://www.mdpi.com/2813-0618/2/1/3
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