Adverse event profiles of microscopic colitis in the Japanese Adverse Drug Event Report (JADER) database
Abstract Microscopic colitis (MC) is a chronic inflammatory bowel disease that is characterized by nonbloody watery diarrhea. The epidemiology in Japan differs from that in Europe and the United States, but little information is available from epidemiological surveys of MC in Japan. This study aimed...
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| Format: | Article |
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Nature Portfolio
2022-10-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-022-22257-2 |
| _version_ | 1798028623864659968 |
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| author | Kaito Yamashiro Mika Jouta Kouichi Hosomi Satoshi Yokoyama Yuu Ozaki Atsushi Hirata Fumihiko Ogata Takehiro Nakamura Shigeharu Tanei Naohito Kawasaki |
| author_facet | Kaito Yamashiro Mika Jouta Kouichi Hosomi Satoshi Yokoyama Yuu Ozaki Atsushi Hirata Fumihiko Ogata Takehiro Nakamura Shigeharu Tanei Naohito Kawasaki |
| author_sort | Kaito Yamashiro |
| collection | DOAJ |
| description | Abstract Microscopic colitis (MC) is a chronic inflammatory bowel disease that is characterized by nonbloody watery diarrhea. The epidemiology in Japan differs from that in Europe and the United States, but little information is available from epidemiological surveys of MC in Japan. This study aimed to provide a new hypothesis regarding the factors associated with MC by using the Japanese Adverse Drug Event Report (JADER) database. “Colitis microscopic” (preferred term code: 10056979) cases entered into the JADER database between 2004 and 2021 were analyzed. Of the 246,997 cases in the JADER database, 161 cases were observed to be associated with MC. A Weibull analysis revealed that the median onset duration of MC (interquartile range) was 72.5 (36.0‒125.5) days in lansoprazole users and 116.0 (60.3‒1089.0) days in aspirin users. A multiple logistic regression analysis revealed that MC was significantly associated with the female sex, as well as ages ≥ 60 years and drugs including lansoprazole, aspirin, and nicorandil. A subset analysis revealed that MC was positively associated with obesity in female cases. Our study cannot demonstrate a causal inference between MC and each drug; however, the findings suggest that MC was associated with nicorandil as well as with lansoprazole and aspirin. |
| first_indexed | 2024-04-11T19:10:55Z |
| format | Article |
| id | doaj.art-94ac86af468741699211efdcecc14029 |
| institution | Directory Open Access Journal |
| issn | 2045-2322 |
| language | English |
| last_indexed | 2024-04-11T19:10:55Z |
| publishDate | 2022-10-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj.art-94ac86af468741699211efdcecc140292022-12-22T04:07:37ZengNature PortfolioScientific Reports2045-23222022-10-011211810.1038/s41598-022-22257-2Adverse event profiles of microscopic colitis in the Japanese Adverse Drug Event Report (JADER) databaseKaito Yamashiro0Mika Jouta1Kouichi Hosomi2Satoshi Yokoyama3Yuu Ozaki4Atsushi Hirata5Fumihiko Ogata6Takehiro Nakamura7Shigeharu Tanei8Naohito Kawasaki9Laboratory of Public Health, Faculty of Pharmacy, Kindai UniversityDepartment of Pharmacy, Kindai University Nara HospitalDivision of Drug Informatics, Faculty of Pharmacy, Kindai UniversityDivision of Drug Informatics, Faculty of Pharmacy, Kindai UniversityDepartment of Pharmacy, Kindai University Nara HospitalDepartment of Pharmacy, Kindai University Nara HospitalLaboratory of Public Health, Faculty of Pharmacy, Kindai UniversityLaboratory of Public Health, Faculty of Pharmacy, Kindai UniversityFaculty of Pharmaceutical Sciences, Nihon Pharmaceutical UniversityLaboratory of Public Health, Faculty of Pharmacy, Kindai UniversityAbstract Microscopic colitis (MC) is a chronic inflammatory bowel disease that is characterized by nonbloody watery diarrhea. The epidemiology in Japan differs from that in Europe and the United States, but little information is available from epidemiological surveys of MC in Japan. This study aimed to provide a new hypothesis regarding the factors associated with MC by using the Japanese Adverse Drug Event Report (JADER) database. “Colitis microscopic” (preferred term code: 10056979) cases entered into the JADER database between 2004 and 2021 were analyzed. Of the 246,997 cases in the JADER database, 161 cases were observed to be associated with MC. A Weibull analysis revealed that the median onset duration of MC (interquartile range) was 72.5 (36.0‒125.5) days in lansoprazole users and 116.0 (60.3‒1089.0) days in aspirin users. A multiple logistic regression analysis revealed that MC was significantly associated with the female sex, as well as ages ≥ 60 years and drugs including lansoprazole, aspirin, and nicorandil. A subset analysis revealed that MC was positively associated with obesity in female cases. Our study cannot demonstrate a causal inference between MC and each drug; however, the findings suggest that MC was associated with nicorandil as well as with lansoprazole and aspirin.https://doi.org/10.1038/s41598-022-22257-2 |
| spellingShingle | Kaito Yamashiro Mika Jouta Kouichi Hosomi Satoshi Yokoyama Yuu Ozaki Atsushi Hirata Fumihiko Ogata Takehiro Nakamura Shigeharu Tanei Naohito Kawasaki Adverse event profiles of microscopic colitis in the Japanese Adverse Drug Event Report (JADER) database Scientific Reports |
| title | Adverse event profiles of microscopic colitis in the Japanese Adverse Drug Event Report (JADER) database |
| title_full | Adverse event profiles of microscopic colitis in the Japanese Adverse Drug Event Report (JADER) database |
| title_fullStr | Adverse event profiles of microscopic colitis in the Japanese Adverse Drug Event Report (JADER) database |
| title_full_unstemmed | Adverse event profiles of microscopic colitis in the Japanese Adverse Drug Event Report (JADER) database |
| title_short | Adverse event profiles of microscopic colitis in the Japanese Adverse Drug Event Report (JADER) database |
| title_sort | adverse event profiles of microscopic colitis in the japanese adverse drug event report jader database |
| url | https://doi.org/10.1038/s41598-022-22257-2 |
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