Safety of gadoversetamide in patients with acute and chronic myocardial infarction.

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.

• Authors: S Huber, R Muthupillai, B Cheong, J H Wible Jr, 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
• Journal: Journal of magnetic resonance imaging : JMRI (J Magn Reson Imaging) Vol. 28 Issue 6 Pg. 1368-78 (Dec 2008) ISSN: 1053-1807 [Print] United States
• PMID: 19025944 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: (c) 2008 Wiley-Liss, Inc.

Chemical References

• Contrast Media
• Organometallic Compounds
• gadoversetamide

Topics

• Acute Disease
• Adult
• Aged
• Aged, 80 and over
• Analysis of Variance
• Chi-Square Distribution
• Chronic Disease
• Contrast Media (administration & dosage, adverse effects)
• Electroencephalography
• Female
• Humans
• Male
• Middle Aged
• Myocardial Infarction (diagnosis)
• Organometallic Compounds (administration & dosage, adverse effects)