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Differential profiles of adverse events associated with mycophenolate mofetil between adult and pediatric renal transplant patients

OBJECTIVE: Immunosuppressive regimens after renal transplantation usually include a combination of calcineurin inhibitors, corticosteroids, and a proliferation inhibitor, either azathioprine or mycophenolate mofetil (MMF), to prevent rejection and maintain graft function. MMF has a stronger immunosu...

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Autores principales: Hosohata, Keiko, Matsuoka, Etsuko, Inada, Ayaka, Oyama, Saki, Niinomi, Iku, Mori, Yasuhiro, Yamaguchi, Yuki, Uchida, Mayako, Iwanaga, Kazunori
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6259373/
https://www.ncbi.nlm.nih.gov/pubmed/30060680
http://dx.doi.org/10.1177/0300060518786917
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author Hosohata, Keiko
Matsuoka, Etsuko
Inada, Ayaka
Oyama, Saki
Niinomi, Iku
Mori, Yasuhiro
Yamaguchi, Yuki
Uchida, Mayako
Iwanaga, Kazunori
author_facet Hosohata, Keiko
Matsuoka, Etsuko
Inada, Ayaka
Oyama, Saki
Niinomi, Iku
Mori, Yasuhiro
Yamaguchi, Yuki
Uchida, Mayako
Iwanaga, Kazunori
author_sort Hosohata, Keiko
collection PubMed
description OBJECTIVE: Immunosuppressive regimens after renal transplantation usually include a combination of calcineurin inhibitors, corticosteroids, and a proliferation inhibitor, either azathioprine or mycophenolate mofetil (MMF), to prevent rejection and maintain graft function. MMF has a stronger immunosuppressive effect than does azathioprine. This study aimed to examine MMF-associated adverse events in renal transplant patients. METHODS: Retrospective pharmacovigilance disproportionality analysis was conducted using the Japanese Adverse Drug Event Report database. RESULTS: A total of 11,594 adverse drug events were reported in renal transplant patients; 10,272 (88.6%) involved adults and 1322 (11.4%) involved children. In adult patients, the most frequent adverse events induced by MMF were cytomegalovirus infection (272 reports), urinary tract infection (69 reports), and polyomavirus-associated nephropathy (61 reports). Among adverse events, the highest reporting odds ratio (ROR) was found for cytomegalovirus infection (ROR, 1.58; 95% confidence interval, 1.36–1.83). In pediatric patients, the rank order for MMF-associated adverse events was cytomegalovirus infection (27 reports), bronchitis (23 reports), and cytomegalovirus viremia (19 reports), but these adverse events were not detected as a signal. CONCLUSION: Our results show the safety profile of MMF in pediatric renal transplant patients. These findings can be used to update information used for prescriptions for pediatric patients.
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spelling pubmed-62593732018-11-30 Differential profiles of adverse events associated with mycophenolate mofetil between adult and pediatric renal transplant patients Hosohata, Keiko Matsuoka, Etsuko Inada, Ayaka Oyama, Saki Niinomi, Iku Mori, Yasuhiro Yamaguchi, Yuki Uchida, Mayako Iwanaga, Kazunori J Int Med Res Clinical Research Reports OBJECTIVE: Immunosuppressive regimens after renal transplantation usually include a combination of calcineurin inhibitors, corticosteroids, and a proliferation inhibitor, either azathioprine or mycophenolate mofetil (MMF), to prevent rejection and maintain graft function. MMF has a stronger immunosuppressive effect than does azathioprine. This study aimed to examine MMF-associated adverse events in renal transplant patients. METHODS: Retrospective pharmacovigilance disproportionality analysis was conducted using the Japanese Adverse Drug Event Report database. RESULTS: A total of 11,594 adverse drug events were reported in renal transplant patients; 10,272 (88.6%) involved adults and 1322 (11.4%) involved children. In adult patients, the most frequent adverse events induced by MMF were cytomegalovirus infection (272 reports), urinary tract infection (69 reports), and polyomavirus-associated nephropathy (61 reports). Among adverse events, the highest reporting odds ratio (ROR) was found for cytomegalovirus infection (ROR, 1.58; 95% confidence interval, 1.36–1.83). In pediatric patients, the rank order for MMF-associated adverse events was cytomegalovirus infection (27 reports), bronchitis (23 reports), and cytomegalovirus viremia (19 reports), but these adverse events were not detected as a signal. CONCLUSION: Our results show the safety profile of MMF in pediatric renal transplant patients. These findings can be used to update information used for prescriptions for pediatric patients. SAGE Publications 2018-07-30 2018-11 /pmc/articles/PMC6259373/ /pubmed/30060680 http://dx.doi.org/10.1177/0300060518786917 Text en © The Author(s) 2018 http://creativecommons.org/licenses/by-nc/4.0/ Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Clinical Research Reports
Hosohata, Keiko
Matsuoka, Etsuko
Inada, Ayaka
Oyama, Saki
Niinomi, Iku
Mori, Yasuhiro
Yamaguchi, Yuki
Uchida, Mayako
Iwanaga, Kazunori
Differential profiles of adverse events associated with mycophenolate mofetil between adult and pediatric renal transplant patients
title Differential profiles of adverse events associated with mycophenolate mofetil between adult and pediatric renal transplant patients
title_full Differential profiles of adverse events associated with mycophenolate mofetil between adult and pediatric renal transplant patients
title_fullStr Differential profiles of adverse events associated with mycophenolate mofetil between adult and pediatric renal transplant patients
title_full_unstemmed Differential profiles of adverse events associated with mycophenolate mofetil between adult and pediatric renal transplant patients
title_short Differential profiles of adverse events associated with mycophenolate mofetil between adult and pediatric renal transplant patients
title_sort differential profiles of adverse events associated with mycophenolate mofetil between adult and pediatric renal transplant patients
topic Clinical Research Reports
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6259373/
https://www.ncbi.nlm.nih.gov/pubmed/30060680
http://dx.doi.org/10.1177/0300060518786917
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