Tolerability and diagnostic value of gadoteric acid in the general population and in patients with risk factors: Results in more than 84,000 patients

Abstract Purpose To review the tolerability and diagnostic effectiveness of gadoteric acid under daily practice conditions in the general population and at-risk patients. Materials and methods A total of 84,621 patients (45.4% men, 54.6% women, mean age 52.0 ± 16.9 years) were studied in 129 German centers. Patients underwent contrast-enhanced magnetic resonance imaging (MRI) using gadoteric acid (Gd-DOTA, Dotarem® , Guerbet, Roissy CdG, France) as IV contrast medium (mean volume, 16.4 ml). 22.9% of the patients had at least one risk factor (e.g., allergies, previous allergic reaction to a contrast medium, and renal impairment). 554 patients received pretreatment before contrast medium administration (0.7%). Adverse events were documented and image quality was assessed. Results A diagnosis was possible in 99.7% of all cases. Image quality was rated good or excellent in 97.1%. Adverse events (e.g., nausea, vomiting, and urticaria) were observed in 0.34% of the examinations and were mostly rated as minor. There were 8 patients with serious adverse events. The adverse event rate was significantly higher in patients with a history of allergies (0.62%; p < 0.001) and in patients with a previous allergic reaction to contrast medium (1.23%; p < 0.001). There was no elevated incidence of adverse events in patients with renal impairment. Conclusion Gadoteric acid is a well-tolerated MRI contrast medium in patients with and without risk factors that is associated with a low rate of adverse events and good or excellent image quality in most patients.