Safety of gadobutrol: results of a non-interventional study of 3710 patients, including 404 children

BACKGROUND: The safety of gadolinium-based contrast agents is a hot topic in radiology. PURPOSE: To evaluate the safety profile of gadobutrol during routine use. MATERIAL AND METHODS: Prospective, non-interventional study in 80 centers in Germany. The primary outcome was the number of adverse drug r...

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Autores principales: Glutig, Katja, Hahn, Gabriele, Kuvvetli, Petra, Endrikat, Jan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2018
Materias:
Contrast Agents
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6604256/
https://www.ncbi.nlm.nih.gov/pubmed/30253660
http://dx.doi.org/10.1177/0284185118801151
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author Glutig, Katja
Hahn, Gabriele
Kuvvetli, Petra
Endrikat, Jan
author_facet Glutig, Katja
Hahn, Gabriele
Kuvvetli, Petra
Endrikat, Jan
author_sort Glutig, Katja
collection PubMed
description BACKGROUND: The safety of gadolinium-based contrast agents is a hot topic in radiology. PURPOSE: To evaluate the safety profile of gadobutrol during routine use. MATERIAL AND METHODS: Prospective, non-interventional study in 80 centers in Germany. The primary outcome was the number of adverse drug reactions (ADR) following gadobutrol administration. RESULTS: A total of 3710 patients were included in the analysis, including 404 children (10.9%). A total of 6026 magnetic resonance imaging examinations of organs/organ systems and 872 magnetic resonance angiography examinations were performed. A total of 22 (0.59%) patients experienced at least one ADR. Nausea and vomiting were the most frequent ADRs, experienced by nine (0.24%) and three (0.08%) patients, respectively. One serious ADR was recorded (anaphylactoid reaction). No deaths were reported. CONCLUSION: This non-interventional study in 3710 patients confirmed gadobutrol as a safe and reliable contrast agent in adults and children.
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spelling pubmed-66042562019-07-24 Safety of gadobutrol: results of a non-interventional study of 3710 patients, including 404 children Glutig, Katja Hahn, Gabriele Kuvvetli, Petra Endrikat, Jan Acta Radiol Contrast Agents BACKGROUND: The safety of gadolinium-based contrast agents is a hot topic in radiology. PURPOSE: To evaluate the safety profile of gadobutrol during routine use. MATERIAL AND METHODS: Prospective, non-interventional study in 80 centers in Germany. The primary outcome was the number of adverse drug reactions (ADR) following gadobutrol administration. RESULTS: A total of 3710 patients were included in the analysis, including 404 children (10.9%). A total of 6026 magnetic resonance imaging examinations of organs/organ systems and 872 magnetic resonance angiography examinations were performed. A total of 22 (0.59%) patients experienced at least one ADR. Nausea and vomiting were the most frequent ADRs, experienced by nine (0.24%) and three (0.08%) patients, respectively. One serious ADR was recorded (anaphylactoid reaction). No deaths were reported. CONCLUSION: This non-interventional study in 3710 patients confirmed gadobutrol as a safe and reliable contrast agent in adults and children. SAGE Publications 2018-09-25 2019-07 /pmc/articles/PMC6604256/ /pubmed/30253660 http://dx.doi.org/10.1177/0284185118801151 Text en © The Foundation Acta Radiologica 2018 http://creativecommons.org/licenses/by-nc/4.0/ 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 Contrast Agents
Glutig, Katja
Hahn, Gabriele
Kuvvetli, Petra
Endrikat, Jan
Safety of gadobutrol: results of a non-interventional study of 3710 patients, including 404 children
title Safety of gadobutrol: results of a non-interventional study of 3710 patients, including 404 children
title_full Safety of gadobutrol: results of a non-interventional study of 3710 patients, including 404 children
title_fullStr Safety of gadobutrol: results of a non-interventional study of 3710 patients, including 404 children
title_full_unstemmed Safety of gadobutrol: results of a non-interventional study of 3710 patients, including 404 children
title_short Safety of gadobutrol: results of a non-interventional study of 3710 patients, including 404 children
title_sort safety of gadobutrol: results of a non-interventional study of 3710 patients, including 404 children
topic Contrast Agents
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6604256/
https://www.ncbi.nlm.nih.gov/pubmed/30253660
http://dx.doi.org/10.1177/0284185118801151
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