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Safety of gadoxetate disodium: results from six clinical phase IV studies in 8194 patients

BACKGROUND: Safety data on routine clinical use of gadoxetate disodium for liver magnetic resonance imaging (MRI) is not reported yet. PURPOSE: To assess the safety profile of gadoxetate disodium for liver MRI in the routine clinical setting. MATERIAL AND METHODS: Six multicenter studies were perfor...

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Autores principales: Endrikat, Jan, Kim, So Yeon, Sakaguchi, Toshiaki, Dohanish, Susan, Breuer, Josy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070494/
https://www.ncbi.nlm.nih.gov/pubmed/26048848
http://dx.doi.org/10.1177/0284185115588126
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author Endrikat, Jan
Kim, So Yeon
Sakaguchi, Toshiaki
Dohanish, Susan
Breuer, Josy
author_facet Endrikat, Jan
Kim, So Yeon
Sakaguchi, Toshiaki
Dohanish, Susan
Breuer, Josy
author_sort Endrikat, Jan
collection PubMed
description BACKGROUND: Safety data on routine clinical use of gadoxetate disodium for liver magnetic resonance imaging (MRI) is not reported yet. PURPOSE: To assess the safety profile of gadoxetate disodium for liver MRI in the routine clinical setting. MATERIAL AND METHODS: Six multicenter studies were performed in Europe, USA, Australia, and Asia to evaluate the safety and efficacy of gadoxetate disodium (Primovist®/Eovist®) enhanced liver MRI. Patients received a single intravenous bolus injection of the standard approved dose of 0.025 mmol/kg body weight (0.1 mL/kg). The number of patients, the characteristics of adverse events, related adverse events, and serious adverse events were analyzed. RESULTS: A total of 8194 patients were included in the database. A total of 141 patients (1.7%) reported 230 AEs of which 129 were considered being related to the use of gadoxetate disodium by the investigators. None of the AEs in the pediatric population (n = 52) were related. The most frequent AEs independent of relationship to the drug included dyspnea (25/0.31%), nausea (22/0.27%), liver disorders (13/0.16%), and renal disorders (9/0.11%). Nine related SAEs were recorded. No patient died during the studies. CONCLUSION: Gadoxetate disodium for liver MRI is safe and well tolerated in the routine clinical setting.
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spelling pubmed-50704942016-10-31 Safety of gadoxetate disodium: results from six clinical phase IV studies in 8194 patients Endrikat, Jan Kim, So Yeon Sakaguchi, Toshiaki Dohanish, Susan Breuer, Josy Acta Radiol Contrast Media BACKGROUND: Safety data on routine clinical use of gadoxetate disodium for liver magnetic resonance imaging (MRI) is not reported yet. PURPOSE: To assess the safety profile of gadoxetate disodium for liver MRI in the routine clinical setting. MATERIAL AND METHODS: Six multicenter studies were performed in Europe, USA, Australia, and Asia to evaluate the safety and efficacy of gadoxetate disodium (Primovist®/Eovist®) enhanced liver MRI. Patients received a single intravenous bolus injection of the standard approved dose of 0.025 mmol/kg body weight (0.1 mL/kg). The number of patients, the characteristics of adverse events, related adverse events, and serious adverse events were analyzed. RESULTS: A total of 8194 patients were included in the database. A total of 141 patients (1.7%) reported 230 AEs of which 129 were considered being related to the use of gadoxetate disodium by the investigators. None of the AEs in the pediatric population (n = 52) were related. The most frequent AEs independent of relationship to the drug included dyspnea (25/0.31%), nausea (22/0.27%), liver disorders (13/0.16%), and renal disorders (9/0.11%). Nine related SAEs were recorded. No patient died during the studies. CONCLUSION: Gadoxetate disodium for liver MRI is safe and well tolerated in the routine clinical setting. SAGE Publications 2015-06-04 2016-11 /pmc/articles/PMC5070494/ /pubmed/26048848 http://dx.doi.org/10.1177/0284185115588126 Text en © The Foundation Acta Radiologica 2015 http://creativecommons.org/licenses/by-nc/3.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 3.0 License (http://www.creativecommons.org/licenses/by-nc/3.0/) 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 page(https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Contrast Media
Endrikat, Jan
Kim, So Yeon
Sakaguchi, Toshiaki
Dohanish, Susan
Breuer, Josy
Safety of gadoxetate disodium: results from six clinical phase IV studies in 8194 patients
title Safety of gadoxetate disodium: results from six clinical phase IV studies in 8194 patients
title_full Safety of gadoxetate disodium: results from six clinical phase IV studies in 8194 patients
title_fullStr Safety of gadoxetate disodium: results from six clinical phase IV studies in 8194 patients
title_full_unstemmed Safety of gadoxetate disodium: results from six clinical phase IV studies in 8194 patients
title_short Safety of gadoxetate disodium: results from six clinical phase IV studies in 8194 patients
title_sort safety of gadoxetate disodium: results from six clinical phase iv studies in 8194 patients
topic Contrast Media
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070494/
https://www.ncbi.nlm.nih.gov/pubmed/26048848
http://dx.doi.org/10.1177/0284185115588126
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