Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients.

Braun, Joachim; Busse, Reinhard; Darmon-Kern, Elisabeth; Heine, Oliver; Auer, Jonas; Meyl, Tobias; Maurer, Martin; Hamm, Bernd; de Bucourt, Maximilian (2020). Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients. Acta radiologica, 61(7), pp. 910-920. Sage 10.1177/0284185119883390

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Background: Magnetic resonance imaging (MRI) examinations with intravenous (IV) contrast are performed worldwidein routine daily practice. In order to detect and enumerate even rare adverse events (AE) and serious adverse events(SAE), and to relate them with patients’ baseline characteristics and diagnostic effectiveness, high quantity sample size isnecessary.
Purpose: To assess safety, diagnostic effectiveness, and baseline characteristics of patients undergoing IV gadoteric acid(DotaremVR) MRI in routine practice.
Material and Methods: Data from two observational post-marketing surveillance (PMS) databases compiled by139 and 52 German centers in 2004–2011 and 2011–2013, respectively, were pooled, yielding data on a total of148,489 patients examined over a 10-year period. Radiologists used a standardized questionnaire to report data including patient demographics, characteristics of MR examinations, and results in terms of diagnosis and patient safety.
Results: Overall, 712 AEs were reported in 467 (0.3%) patients, mainly nausea (n¼224, 0.2%), vomiting (n¼29,<0.1%), urticaria (n¼20,<0.1%), and feeling hot (n¼13,<0.1%). AEs were considered related to gadoteric acid in362 (0.2%) patients. Higher frequencies of AEs were observed among patients with a previous reaction to a contrastagent (2.0%), liver dysfunction (0.7%), bronchial asthma (0.7%), and a history of allergies (0.6%). There were 49 SAEs in18 (<0.1%) patients, including two children. No fatal SAE was reported. Examinations were diagnostic in 99.8% of allpatients, and image quality was excellent or good in 97.7% of the patients.
Conclusion: Gadoteric acid is a safe peri-examinational and effective contrast agent for MRI in routine practice.

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