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Safety of gadoversetamide in patients with acute and chronic myocardial infarction
Author(s) -
Huber S.,
Muthupillai R.,
Cheong B.,
Wible J.H.,
Shah D.,
Woodard P.,
Grothues F.,
Mahrholdt H.,
Rochitte C.E.,
Masoli O.,
Kim R.J.,
Schwaiger C.M.,
Fuisz A.,
Kramer C.,
van Rossum A.C.,
Biederman R.,
Lombardi M.,
Martin E.,
Kevorkian R.,
Flamm S.D.
Publication year - 2008
Publication title -
journal of magnetic resonance imaging
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.563
H-Index - 160
eISSN - 1522-2586
pISSN - 1053-1807
DOI - 10.1002/jmri.21502
Subject(s) - medicine , myocardial infarction , adverse effect , mallinckrodt , magnetic resonance imaging , population , nuclear medicine , cardiology , radiology , environmental health , family medicine
Purpose 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). Materials and 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. Conclusion Gadoversetamide is safe for use in patients with acute or chronic MI up to a dose of 0.3 mmol/kg. J. Magn. Reson. Imaging 2008;28:1368–1378. © 2008 Wiley‐Liss, Inc.