title: Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  • 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.
authors.affiliation: Department of Radiology, Weill Cornell Medical College, 416 east 55th Street, New York, NY, 10022, USA. map2008@med.cornell.edu.|Department of Radiology, Columbia College of Physicians and Surgeons, New York, NY, 10021, USA. map2008@med.cornell.edu.
authors.forename: Martin R
authors.initials: MR
authors.lastname: Prince
authors.affiliation: Department of Radiology, Seoul St. Mary's Hospital, The Catholic University of Korea, College of Medicine, Seoul, South Korea.
authors.forename: Hae Giu
authors.initials: HG
authors.lastname: Lee
authors.affiliation: Department of Radiology, Korea University Guro Hospital, Seoul, South Korea.
authors.forename: Chang-Hee
authors.initials: CH
authors.lastname: Lee
authors.affiliation: Department of Radiology, Catholic University of Daegu Medical Center, Daegu, South Korea.
authors.forename: Sung Won
authors.initials: SW
authors.lastname: Youn
authors.affiliation: Department of Radiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, South Korea.
authors.forename: In Ho
authors.initials: IH
authors.lastname: Lee
authors.affiliation: Department of Radiology, Chonnam National University Hospital, Gwangju, South Korea.
authors.forename: Woong
authors.initials: W
authors.lastname: Yoon
authors.affiliation: Department of Radiology, General Hospital of Shenyang Military Region, Shenyang, China.
authors.forename: Benqiang
authors.initials: B
authors.lastname: Yang
authors.affiliation: Department of Radiology, Tangshan Worker's Hospital, Tangshan, China.
authors.forename: Haiping
authors.initials: H
authors.lastname: Wang
authors.affiliation: Department of Radiology, Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
authors.forename: Jin
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Radiology and Medical Imaging, National Taiwan University, Medical College and Hospital, Taipei, Taiwan.
authors.forename: Tiffany Ting-Fang
authors.initials: TT
authors.lastname: Shih
authors.affiliation: Department of Radiology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.
authors.forename: Guo-Shu
authors.initials: GS
authors.lastname: Huang
authors.affiliation: Department of Radiology, Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Jiing-Feng
authors.initials: JF
authors.lastname: Lirng
authors.affiliation: Medical & Clinical Affairs Radiology, Bayer Pharmaceutical Division, Berlin, Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Palkowitsch
mesh_terms: D000293:Adolescent; D000328:Adult; D000349:Africa; D000368:Aged; D000369:Aged, 80 and over; D001208:Asia; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000009:adverse effects*; D005060:Europe; D005260:Female; D006801:Humans; D007089:Image Enhancement / Q000379:methods*; D018810:Magnetic Resonance Angiography; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009656:North America; D009942:Organometallic Compounds / Q000009:adverse effects*; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; C090600:gadobutrol
keywords: Adverse drug reaction; Contrast media; Gadobutrol; Magnetic resonance imaging; Safety