Safety of gadoversetamide in patients with acute and chronic myocardial infarction

S. Huber, R. Muthupillai, B. Cheong, J. H. Wible, D. Shah, P. Woodard, F. Grothues, H. Mahrholdt, C. E. Rochitte, O. Masoli, R. J. Kim, C. M. Schwaiger, A. Fuisz, C. Kramer, A. C. Van Rossum, R. Biederman, M. Lombardi, E. Martin, R. Kevorkian, S. D. Flamm

Research output: Contribution to journalArticle

8 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1368-1378
Number of pages11
JournalJournal of Magnetic Resonance Imaging
Volume28
Issue number6
DOIs
StatePublished - Dec 2008

Keywords

  • Contrast agent
  • Delayed hyperenhancement magnetic resonance imaging
  • Gadolinium chelates
  • Gadoversetamide
  • Safety

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

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