title: Safety of gadoversetamide in patients with acute and chronic myocardial infarction.
abstract: OBJECTIVE
  To assess the safety data from two large, multicenter, phase 2 trials on the use of gadoversetamide (OptiMARK, Tyco Healthcare/Mallinckrodt, St. Louis, MO) as a contrast agent in delayed hyperenhancement magnetic resonance imaging (DE-MRI) in patients with acute and chronic myocardial infarction (MI).
  
  
  METHODS
  The study population from both trials comprised 577 patients who were randomly assigned to one of four dose groups (0.05, 0.1, 0.2, or 0.3 mmol/kg) before undergoing DE-MRI. Safety evaluations included physical and electrocardiographic (ECG) examinations. Vital signs, laboratory values, adverse events (AE), and serious adverse events (SAE) were monitored before and after contrast administration.
  
  
  RESULTS
  Of the 577 patients who received gadoversetamide, 124 (21.5%) reported a total of 164 AEs; most were mild (139 AEs; 84.8%) or moderate (25 AEs; 15.2%). ECG-related changes were the most frequent AE. Site investigators judged only eight AEs as likely related to gadoversetamide and only two of the eight as clinically relevant. Further evaluation suggested neither AE was related to gadoversetamide. Two SAEs were reported, but none was judged related to gadoversetamide by the site investigators.
  
  
  CONCLUSIONS
  Gadoversetamide is safe for use in patients with acute or chronic MI up to a dose of 0.3 mmol/kg.
authors.affiliation: Advanced Cardiovascular Imaging, Department of Radiology, MC 2-270, St. Luke's Episcopal Hospital and the Texas Heart Institute, 6720 Bertner Ave., Houston, Texas, 77030, USA. st.huber@gmx.net
authors.forename: S
authors.initials: S
authors.lastname: Huber
authors.forename: R
authors.initials: R
authors.lastname: Muthupillai
authors.forename: B
authors.initials: B
authors.lastname: Cheong
authors.forename: J H
authors.initials: JH
authors.lastname: Wible
authors.forename: D
authors.initials: D
authors.lastname: Shah
authors.forename: P
authors.initials: P
authors.lastname: Woodard
authors.forename: F
authors.initials: F
authors.lastname: Grothues
authors.forename: H
authors.initials: H
authors.lastname: Mahrholdt
authors.forename: C E
authors.initials: CE
authors.lastname: Rochitte
authors.forename: O
authors.initials: O
authors.lastname: Masoli
authors.forename: R J
authors.initials: RJ
authors.lastname: Kim
authors.forename: C M
authors.initials: CM
authors.lastname: Schwaiger
authors.forename: A
authors.initials: A
authors.lastname: Fuisz
authors.forename: C
authors.initials: C
authors.lastname: Kramer
authors.forename: A C
authors.initials: AC
authors.lastname: van Rossum
authors.forename: R
authors.initials: R
authors.lastname: Biederman
authors.forename: M
authors.initials: M
authors.lastname: Lombardi
authors.forename: E
authors.initials: E
authors.lastname: Martin
authors.forename: R
authors.initials: R
authors.lastname: Kevorkian
authors.forename: S D
authors.initials: SD
authors.lastname: Flamm
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D002908:Chronic Disease; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects; D004569:Electroencephalography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis*; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; C112666:gadoversetamide