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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Detalles Bibliográficos
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
Descripción
Sumario: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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