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European Radiology
Published in: European Radiology 1/2017

Open Access 01-01-2017 | Magnetic Resonance

Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study

Authors: Martin R. Prince, Hae Giu Lee, Chang-Hee Lee, Sung Won Youn, In Ho Lee, Woong Yoon, Benqiang Yang, Haiping Wang, Jin Wang, Tiffany Ting-fang Shih, Guo-Shu Huang, Jiing-Feng Lirng, Petra Palkowitsch, on behalf of the GARDIAN study group

Published in: European Radiology | Issue 1/2017

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Abstract

Objectives

To investigate the safety and tolerability of gadobutrol at the recommended dose in patients requiring contrast-enhanced magnetic resonance imaging/angiography (MRI/MRA) in the routine setting.

Methods

GARDIAN prospectively enrolled 23,708 patients undergoing routine gadobutrol-enhanced MRI/MRA for approved indications at 272 study centres in Europe, Asia, North America, and Africa and monitored for adverse events.

Results

Median gadobutrol dose was 0.11 mmol/kg body weight. The overall incidence of adverse drug reactions (ADRs) was 0.7 % (n = 170 patients), with similar incidences in patients with renal impairment or cardiac disease, from different geographic regions and in different gadobutrol dose groups. Patients at risk for contrast media reaction had an ADR incidence of 2.5 %. Five patients (0.02 %) experienced serious adverse events, four were drug-related. One patient experienced a fatal anaphylactoid shock, assessed to be related to injection of gadobutrol. The contrast quality of gadobutrol-enhanced images was rated by treating physicians as good or excellent in 97 % cases, with similar ratings in all patient subgroups and indications.

Conclusions

The GARDIAN study shows that gadobutrol at the recommended dose is well tolerated across a large, diverse patient population.

Key points

• Gadobutrol at recommended dose shows low rates of adverse drug reactions
• Gadobutrol demonstrates a uniform safety profile across diverse patient groups
• Gadobutrol provides excellent contrast quality in routine practice
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Metadata
Title
Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study
Authors
Martin R. Prince
Hae Giu Lee
Chang-Hee Lee
Sung Won Youn
In Ho Lee
Woong Yoon
Benqiang Yang
Haiping Wang
Jin Wang
Tiffany Ting-fang Shih
Guo-Shu Huang
Jiing-Feng Lirng
Petra Palkowitsch
on behalf of the GARDIAN study group
Publication date
01-01-2017
Publisher
Springer Berlin Heidelberg
Published in
European Radiology / Issue 1/2017
Print ISSN: 0938-7994
Electronic ISSN: 1432-1084
DOI
https://doi.org/10.1007/s00330-016-4268-8

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