Safety of gadoversetamide in patients with acute and chronic myocardial infarction.
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.
Huber
S
S
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
Muthupillai
R
R
Cheong
B
B
Wible
J H
JH
Shah
D
D
Woodard
P
P
Grothues
F
F
Mahrholdt
H
H
Rochitte
C E
CE
Masoli
O
O
Kim
R J
RJ
Schwaiger
C M
CM
Fuisz
A
A
Kramer
C
C
van Rossum
A C
AC
Biederman
R
R
Lombardi
M
M
Martin
E
E
Kevorkian
R
R
Flamm
S D
SD
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
D003287:Contrast Media; D009942:Organometallic Compounds; C112666:gadoversetamide