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%). ECGrelated 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.

The Impact of Excess Ligand on the Retention of Nonionic, Linear Gadolinium-Based Contrast Agents in Patients With Various Levels of Renal Dysfunction: A Review and Simulation Analysis

“…In clinical trials for a variety of indications, Omniscan ® is associated with adverse events in 8.4% of patients 32,33,34,35,36 , while adverse events occur in 28.3% of OptiMARK ® patients 37,38 . This trend is also observed in non-NSF adverse event reports submitted to the FDA, in which 8.3 events per million doses have been reported for OptiMARK ® , but only 4.7 events per million doses have been reported for Omniscan ®39 .…”

Adaptive removal of gradients-induced artefacts on ECG in MRI: a performance analysis of RLS filtering

“…ECG can be used in monitoring neonatal or paediatric patients [7], interventional MRI procedures [14], assessment of drugs or contrast agents [12], patient with implanted pacemaker or defibrillator [8], cardiac triggering [7] and patient monitoring [13].…”

Gadolinium Can Depict Area at Risk and Myocardial Infarction

“…The optimal timing of those two time periods will need to be defined more precisely. For the short term, the best available data(Huber, Muthupillai et al 2008) indicates we should wait at least 10 minutes after injection for accurate infarct sizing but a 20 minute wait would be safer still. More work is needed to define the kinetics separating these two critical measurements such as renal function and microvascular obstruction.…”