Objectives: Prospective studies and retrospective analyses were undertaken to evaluate the clinical safety of gadobenate dimeglumine (MultiHance) and to assess tolerability in special populations.
Materials and methods: A total of 3092 subjects received MultiHance in 79 clinical trials. Data from comparisons with other contrast agents and studies in children, subjects with hepatic or renal impairment, or subjects with coronary artery disease were reviewed. Postmarketing safety surveillance data after more than 1.5 million applications were also evaluated.
Results: In total, 413 of 2982 (14%) adult subjects receiving MultiHance reported at least one adverse event (AE) definitely or potentially related to MultiHance, an incidence that was similar to that observed with placebo (21/127, 17%) or active controls (59/723, 8%). In crossover studies, 23 of 287 (8%) subjects receiving MultiHance experienced AE compared with 25 of 295 (9%) receiving gadopentetate dimeglumine (Magnevist). No increased AE rate was observed in children and no worsening of renal or liver function was observed in subjects with hepatic or renal impairment. No detrimental effect on cardiac electrophysiology could be observed from a retrospective analysis of ECG parameters in more than 1000 patients and healthy volunteers. The AE reporting rate from postmarketing safety surveillance of MultiHance was 0.05%. Serious AEs were rarely reported and included dyspnea, nausea, urticaria, hypotension, and anaphylactoid reactions.
Conclusions: MultiHance appears to be well tolerated in adults and children and in subjects with impaired liver or kidney function or coronary artery disease. In controlled trials, MultiHance demonstrated a similar safety profile to that of Magnevist.