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

on behalf of the GARDIAN study group

doi:10.1007/s00330-016-4268-8

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

on behalf of the GARDIAN study group

Research output: Contribution to journal › Article › peer-review

30 Citations (Scopus)

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.

Original language	English
Pages (from-to)	286-295
Number of pages	10
Journal	European Radiology
Volume	27
Issue number	1
DOIs	https://doi.org/10.1007/s00330-016-4268-8
Publication status	Published - 2017 Jan 1
Externally published	Yes

Bibliographical note

Funding Information:
Bayer Pharmaceutical Division provided support in the design and conduct of the study and in the collection, management and analysis of the data. Editorial support for this manuscript was provided by Bill Wolvey of PAREXEL, which was funded by Bayer Pharmaceutical Division. Statistical support was provided by Dr. Christine Windemuth-Kieselbach, Head of Biometry, Alcedis GmbH. The scientific guarantor of this publication is Dr Petra Palkowitsch. Dr Martin Prince has a patent agreement with Bayer related to MR angiography

Publisher Copyright:
© 2016, The Author(s).

Keywords

Adverse drug reaction
Contrast media
Gadobutrol
Magnetic resonance imaging
Safety

ASJC Scopus subject areas

Radiology Nuclear Medicine and imaging

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10.1007/s00330-016-4268-8

Cite this

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

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.",

keywords = "Adverse drug reaction, Contrast media, Gadobutrol, Magnetic resonance imaging, Safety",

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

note = "Funding Information: Bayer Pharmaceutical Division provided support in the design and conduct of the study and in the collection, management and analysis of the data. Editorial support for this manuscript was provided by Bill Wolvey of PAREXEL, which was funded by Bayer Pharmaceutical Division. Statistical support was provided by Dr. Christine Windemuth-Kieselbach, Head of Biometry, Alcedis GmbH. The scientific guarantor of this publication is Dr Petra Palkowitsch. Dr Martin Prince has a patent agreement with Bayer related to MR angiography Publisher Copyright: {\textcopyright} 2016, The Author(s).",

year = "2017",

month = jan,

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doi = "10.1007/s00330-016-4268-8",

language = "English",

volume = "27",

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AU - Lee, Hae Giu

AU - Lee, Chang Hee

AU - Youn, Sung Won

AU - Lee, In Ho

AU - Yoon, Woong

AU - Yang, Benqiang

AU - Wang, Haiping

AU - Wang, Jin

AU - Shih, Tiffany Ting fang

AU - Huang, Guo Shu

AU - Lirng, Jiing Feng

AU - Palkowitsch, Petra

N1 - Funding Information: Bayer Pharmaceutical Division provided support in the design and conduct of the study and in the collection, management and analysis of the data. Editorial support for this manuscript was provided by Bill Wolvey of PAREXEL, which was funded by Bayer Pharmaceutical Division. Statistical support was provided by Dr. Christine Windemuth-Kieselbach, Head of Biometry, Alcedis GmbH. The scientific guarantor of this publication is Dr Petra Palkowitsch. Dr Martin Prince has a patent agreement with Bayer related to MR angiography Publisher Copyright: © 2016, The Author(s).

PY - 2017/1/1

Y1 - 2017/1/1

N2 - 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.

AB - 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.

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

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

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