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 journalArticle

15 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. 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

Original languageEnglish
Pages (from-to)286-295
Number of pages10
JournalEuropean Radiology
Volume27
Issue number1
DOIs
Publication statusPublished - 2017 Jan 1

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Safety
Drug-Related Side Effects and Adverse Reactions
Magnetic Resonance Angiography
Incidence
Magnetic Resonance Imaging
gadobutrol
Northern Africa
North America
Contrast Media
Heart Diseases
Shock
Body Weight
Physicians
Kidney
Injections
Pharmaceutical Preparations
Population

Keywords

  • Adverse drug reaction
  • Contrast media
  • Gadobutrol
  • Magnetic resonance imaging
  • Safety

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

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.

In: European Radiology, Vol. 27, No. 1, 01.01.2017, p. 286-295.

Research output: Contribution to journalArticle

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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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AU - Youn, Sung Won

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AU - Yoon, Woong

AU - Yang, Benqiang

AU - Wang, Haiping

AU - Wang, Jin

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AU - Huang, Guo Shu

AU - Lirng, Jiing Feng

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