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

Autor: Martin R. Prince, Tiffany Ting-Fang Shih, Woong Yoon, Jiing-Feng Lirng, In Ho Lee, Hae Giu Lee, Chang Hee Lee, Guo-Shu Huang, Benqiang Yang, Sung Won Youn, Jin Wang, Haiping Wang, Petra Palkowitsch
Rok vydání: 2016
Předmět:
Adult
Male
medicine.medical_specialty
Asia
Adolescent
Adverse drug reaction
Contrast Media
Magnetic resonance angiography
Gadobutrol
030218 nuclear medicine & medical imaging
Young Adult
03 medical and health sciences
Magnetic resonance imaging
0302 clinical medicine
Organometallic Compounds
medicine
Humans
Radiology
Nuclear Medicine and imaging
Magnetic Resonance
Prospective Studies
Child
Prospective cohort study
Aged
Neuroradiology
Aged
80 and over
medicine.diagnostic_test
business.industry
Interventional radiology
General Medicine
Middle Aged
Image Enhancement
Europe
Tolerability
Radiology Nuclear Medicine and imaging
Child
Preschool
030220 oncology & carcinogenesis
Africa
North America
Angiography
Female
Radiology
Safety
business
Nuclear medicine
Magnetic Resonance Angiography
medicine.drug
Zdroj: European Radiology
ISSN: 1432-1084
0938-7994
DOI: 10.1007/s00330-016-4268-8
Popis: 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
Databáze: OpenAIRE
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