title: Safety of gadobutrol in more than 1,000 pediatric patients: subanalysis of the GARDIAN study, a global multicenter prospective non-interventional study.
abstract: BACKGROUND
  Gadobutrol is a gadolinium-based contrast agent, uniquely formulated at 1.0 mmol/ml. Although there is extensive safety evidence on the use of gadobutrol in adults, few studies have addressed the safety and tolerability of gadobutrol in pediatric patients.
  
  
  OBJECTIVE
  This subanalysis of data from the GARDIAN study evaluated the safety and use of gadobutrol in pediatric patients (age <18 years).
  
  
  METHODS
  The GARDIAN study was a large phase IV non-interventional prospective multicenter post-authorization safety study performed in Europe, Asia, North America and Africa. A total of 23,708 patients were included who were scheduled to undergo cranial or spinal MRI, liver or kidney MRI, or MR angiography with gadobutrol enhancement. The primary study endpoint was the overall incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs) following gadobutrol administration.
  
  
  RESULTS
  The GARDIAN study included 1,142 children (age <18 years) who received gadobutrol at a mean dose of 0.13 (range 0.04-0.50) mmol/kg body weight. Gadobutrol was well tolerated in these children, with low rates of ADRs (0.5%) and no SAEs, consistent with results in adults enrolled in the GARDIAN study. Rates of adverse events and ADRs were unrelated to pediatric age or gadobutrol weight-adjusted dose. There were no symptoms suggestive of nephrogenic systemic fibrosis. Investigators rated the contrast quality of gadobutrol-enhanced images as good or excellent in 97.8% of pediatric patients, similar to the main study population.
  
  
  CONCLUSIONS
  Gadobutrol is very well tolerated and provides excellent contrast quality at the recommended weight-adjusted dose in children (age <18 years), similar to the profile in adults.
authors.affiliation: Children's Center Dresden-Friedrichstadt, Fachärztin für Radiologie und Kinderradiologie, Überörtliche Radiologische Gemeinschaftspraxis Dresden-Loschwitz, Standort Kinderzentrum Dresden-Friedrichstadt, Friedrichstr. 32, 01067, Dresden, Germany. katja.glutig@kid-dresden.de.
authors.forename: Katja
authors.initials: K
authors.lastname: Glutig
authors.affiliation: Stollery Children's Hospital, University of Alberta, Edmonton, AB, Canada.
authors.forename: Ravi
authors.initials: R
authors.lastname: Bhargava
authors.affiliation: Pediatric Radiology, University Hospital Carl Gustav Carus Dresden, Dresden, Germany.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Hahn
authors.affiliation: Pediatric Radiology, University Hospital Leipzig, Leipzig, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hirsch
authors.affiliation: Pediatric Radiology, Martin-Luther-University Hospital Halle/Wittenberg, Halle, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Kunze
authors.affiliation: Pediatric Radiology, University Hospital Jena, Jena, Germany.
authors.forename: Hans-Joachim
authors.initials: HJ
authors.lastname: Mentzel
authors.affiliation: Division of Radiology, University Hospital Tuebingen, Tuebingen, Germany.
authors.forename: Jürgen F
authors.initials: JF
authors.lastname: Schaefer
authors.affiliation: Radiology, University Hospital Bonn, Bonn, Germany.
authors.forename: Winfried
authors.initials: W
authors.lastname: Willinek
authors.affiliation: Medical & Clinical Affairs Radiology, Bayer Pharma, Berlin, Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Palkowitsch
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000008:administration & dosage* / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000209:etiology; D005260:Female; D006801:Humans; D007089:Image Enhancement / Q000379:methods; D007223:Infant; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D009942:Organometallic Compounds / Q000008:administration & dosage* / Q000009:adverse effects*; D011446:Prospective Studies
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; C090600:gadobutrol
keywords: Children; Gadobutrol; Gadolinium-based contrast agent; Magnetic resonance angiography; Magnetic resonance imaging