title: Tolerability and diagnostic value of gadoteric acid in the general population and in patients with risk factors: results in more than 84,000 patients.
abstract: OBJECTIVE
  To review the tolerability and diagnostic effectiveness of gadoteric acid under daily practice conditions in the general population and at-risk patients.
  
  
  METHODS
  A total of 84,621 patients (45.4% men, 54.6% women, mean age 52.0 ± 16.9 years) were studied in 129 German centers. Patients underwent contrast-enhanced magnetic resonance imaging (MRI) using gadoteric acid (Gd-DOTA, Dotarem(®), Guerbet, Roissy CdG, France) as IV contrast medium (mean volume, 16.4 ml). 22.9% of the patients had at least one risk factor (e.g., allergies, previous allergic reaction to a contrast medium, and renal impairment). 554 patients received pretreatment before contrast medium administration (0.7%). Adverse events were documented and image quality was assessed.
  
  
  RESULTS
  A diagnosis was possible in 99.7% of all cases. Image quality was rated good or excellent in 97.1%. Adverse events (e.g., nausea, vomiting, and urticaria) were observed in 0.34% of the examinations and were mostly rated as minor. There were 8 patients with serious adverse events. The adverse event rate was significantly higher in patients with a history of allergies (0.62%; p<0.001) and in patients with a previous allergic reaction to contrast medium (1.23%; p<0.001). There was no elevated incidence of adverse events in patients with renal impairment.
  
  
  CONCLUSIONS
  Gadoteric acid is a well-tolerated MRI contrast medium in patients with and without risk factors that is associated with a low rate of adverse events and good or excellent image quality in most patients.
authors.affiliation: Charité - University Medicine Berlin, Department of Radiology, Augustenburger Platz 1, 13353 Berlin, Germany. martin.maurer@charite.de
authors.forename: Martin
authors.initials: M
authors.lastname: Maurer
authors.forename: Oliver
authors.initials: O
authors.lastname: Heine
authors.forename: Michael
authors.initials: M
authors.lastname: Wolf
authors.forename: Tahir
authors.initials: T
authors.lastname: Durmus
authors.forename: Moritz
authors.initials: M
authors.lastname: Wagner
authors.forename: Bernd
authors.initials: B
authors.lastname: Hamm
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D015897:Comorbidity; D003287:Contrast Media / Q000009:adverse effects; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008536:Meglumine / Q000009:adverse effects*; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000453:epidemiology*; D009942:Organometallic Compounds / Q000009:adverse effects*; D015995:Prevalence; D018570:Risk Assessment; D012307:Risk Factors; D014581:Urticaria / Q000139:chemically induced / Q000453:epidemiology*; D014839:Vomiting / Q000139:chemically induced / Q000453:epidemiology*; D055815:Young Adult
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; D008536:Meglumine; C072417:gadoterate meglumine