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Evaluation of anti-infective-related Clostridium difficile-associated colitis using the Japanese Adverse Drug Event Report database

Clostridium difficile-associated colitis (CDAC) may cause gastrointestinal illness, ranging in severity from mild diarrhea to fulminant colitis and even mortality. The purpose of this study was to evaluate anti-infective-related CDAC profiles using the Japanese Adverse Drug Event Report (JADER) data...

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Autores principales: Nakao, Satoshi, Hasegawa, Shiori, Shimada, Kazuyo, Mukai, Ririka, Tanaka, Mizuki, Matsumoto, Kiyoka, Uranishi, Hiroaki, Masuta, Mayuko, Ikesue, Hiroaki, Hashida, Tohru, Iguchi, Kazuhiro, Nakamura, Mitsuhiro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Ivyspring International Publisher 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7163355/
https://www.ncbi.nlm.nih.gov/pubmed/32308545
http://dx.doi.org/10.7150/ijms.43789
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author Nakao, Satoshi
Hasegawa, Shiori
Shimada, Kazuyo
Mukai, Ririka
Tanaka, Mizuki
Matsumoto, Kiyoka
Uranishi, Hiroaki
Masuta, Mayuko
Ikesue, Hiroaki
Hashida, Tohru
Iguchi, Kazuhiro
Nakamura, Mitsuhiro
author_facet Nakao, Satoshi
Hasegawa, Shiori
Shimada, Kazuyo
Mukai, Ririka
Tanaka, Mizuki
Matsumoto, Kiyoka
Uranishi, Hiroaki
Masuta, Mayuko
Ikesue, Hiroaki
Hashida, Tohru
Iguchi, Kazuhiro
Nakamura, Mitsuhiro
author_sort Nakao, Satoshi
collection PubMed
description Clostridium difficile-associated colitis (CDAC) may cause gastrointestinal illness, ranging in severity from mild diarrhea to fulminant colitis and even mortality. The purpose of this study was to evaluate anti-infective-related CDAC profiles using the Japanese Adverse Drug Event Report (JADER) database. Methods: We selected case reports of adverse events of CDAC as specified in the Medical Dictionary for Regulatory Activities. The association between the number of administered anti-infectives and aging was evaluated using reporting odds ratio (ROR) and adjusted for covariates using multiple-logistic regression. We also evaluated anti-infective-related CDAC-onset profiles using Weibull shape parameter. Results: The JADER database contained 534 688 reports from April 2004 to June 2018. There were 1222 anti-infective related CDAC events. The top five anti-infectives were as follows: third-generation cephalosporins (Anatomical Therapeutic Chemical (ATC) code: J01DD, 313 cases), fluoroquinolones (ATC code: J01MA, 201 cases), macrolides (ATC code: J01FA, 146 cases), carbapenems (ATC code: J01DH, 143 cases), and penicillins with extended spectrum (ATC code: J01CA, 103 cases). The adjusted RORs (95% confidence interval) in individuals using 1, 2, and ≥ 3 anti-infectives were 8.88 (7.05-11.18), 9.77 (6.89-13.86), and 18.39 (11.85-28.54), respectively. Moreover, 47.2% of CDACs occurred within 7 days of anti-infective therapy initiation. The adjusted ROR of interaction terms of ≥ 70 years × 1 drug was 21.81 (14.56-32.68). Conclusion: Our results suggest that the number of administered anti-infectives and patient age are associated with CDAC. These data may be particularly beneficial to prescribers and would contribute to improving the management of CDAC.
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spelling pubmed-71633552020-04-17 Evaluation of anti-infective-related Clostridium difficile-associated colitis using the Japanese Adverse Drug Event Report database Nakao, Satoshi Hasegawa, Shiori Shimada, Kazuyo Mukai, Ririka Tanaka, Mizuki Matsumoto, Kiyoka Uranishi, Hiroaki Masuta, Mayuko Ikesue, Hiroaki Hashida, Tohru Iguchi, Kazuhiro Nakamura, Mitsuhiro Int J Med Sci Research Paper Clostridium difficile-associated colitis (CDAC) may cause gastrointestinal illness, ranging in severity from mild diarrhea to fulminant colitis and even mortality. The purpose of this study was to evaluate anti-infective-related CDAC profiles using the Japanese Adverse Drug Event Report (JADER) database. Methods: We selected case reports of adverse events of CDAC as specified in the Medical Dictionary for Regulatory Activities. The association between the number of administered anti-infectives and aging was evaluated using reporting odds ratio (ROR) and adjusted for covariates using multiple-logistic regression. We also evaluated anti-infective-related CDAC-onset profiles using Weibull shape parameter. Results: The JADER database contained 534 688 reports from April 2004 to June 2018. There were 1222 anti-infective related CDAC events. The top five anti-infectives were as follows: third-generation cephalosporins (Anatomical Therapeutic Chemical (ATC) code: J01DD, 313 cases), fluoroquinolones (ATC code: J01MA, 201 cases), macrolides (ATC code: J01FA, 146 cases), carbapenems (ATC code: J01DH, 143 cases), and penicillins with extended spectrum (ATC code: J01CA, 103 cases). The adjusted RORs (95% confidence interval) in individuals using 1, 2, and ≥ 3 anti-infectives were 8.88 (7.05-11.18), 9.77 (6.89-13.86), and 18.39 (11.85-28.54), respectively. Moreover, 47.2% of CDACs occurred within 7 days of anti-infective therapy initiation. The adjusted ROR of interaction terms of ≥ 70 years × 1 drug was 21.81 (14.56-32.68). Conclusion: Our results suggest that the number of administered anti-infectives and patient age are associated with CDAC. These data may be particularly beneficial to prescribers and would contribute to improving the management of CDAC. Ivyspring International Publisher 2020-03-26 /pmc/articles/PMC7163355/ /pubmed/32308545 http://dx.doi.org/10.7150/ijms.43789 Text en © The author(s) This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/). See http://ivyspring.com/terms for full terms and conditions.
spellingShingle Research Paper
Nakao, Satoshi
Hasegawa, Shiori
Shimada, Kazuyo
Mukai, Ririka
Tanaka, Mizuki
Matsumoto, Kiyoka
Uranishi, Hiroaki
Masuta, Mayuko
Ikesue, Hiroaki
Hashida, Tohru
Iguchi, Kazuhiro
Nakamura, Mitsuhiro
Evaluation of anti-infective-related Clostridium difficile-associated colitis using the Japanese Adverse Drug Event Report database
title Evaluation of anti-infective-related Clostridium difficile-associated colitis using the Japanese Adverse Drug Event Report database
title_full Evaluation of anti-infective-related Clostridium difficile-associated colitis using the Japanese Adverse Drug Event Report database
title_fullStr Evaluation of anti-infective-related Clostridium difficile-associated colitis using the Japanese Adverse Drug Event Report database
title_full_unstemmed Evaluation of anti-infective-related Clostridium difficile-associated colitis using the Japanese Adverse Drug Event Report database
title_short Evaluation of anti-infective-related Clostridium difficile-associated colitis using the Japanese Adverse Drug Event Report database
title_sort evaluation of anti-infective-related clostridium difficile-associated colitis using the japanese adverse drug event report database
topic Research Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7163355/
https://www.ncbi.nlm.nih.gov/pubmed/32308545
http://dx.doi.org/10.7150/ijms.43789
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