Journal article
Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients.
- Braun J Department of Radiology, Charité - University Medicine, Berlin, Germany.
- Busse R Department of Health Care Management, Faculty of Economics and Management, Berlin University of Technology, Berlin, Germany.
- Darmon-Kern E Guerbet, Roissy CDG Cedex, France.
- Heine O Guerbet GmbH, Sulzbach, Germany.
- Auer J Department of Radiology, Charité - University Medicine, Berlin, Germany.
- Meyl T Department of Diagnostic, Interventional and Pediatric Radiology, Inselspital, University of Bern, Bern, Switzerland.
- Maurer M Department of Diagnostic, Interventional and Pediatric Radiology, Inselspital, University of Bern, Bern, Switzerland.
- Hamm B Department of Radiology, Charité - University Medicine, Berlin, Germany.
- de Bucourt M Department of Radiology, Charité - University Medicine, Berlin, Germany.
- 2019-11-20
Published in:
- Acta radiologica (Stockholm, Sweden : 1987). - 2020
Magnetic resonance imaging
adverse drug reactions
efficacy
gadoteric acid
post-marketing surveillance
safety
Adolescent
Adult
Aged
Aged, 80 and over
Child
Child, Preschool
Contrast Media
Female
Germany
Humans
Infant
Infusions, Intravenous
Magnetic Resonance Imaging
Male
Meglumine
Middle Aged
Organometallic Compounds
Product Surveillance, Postmarketing
Surveys and Questionnaires
English
BACKGROUND
Magnetic resonance imaging (MRI) examinations with intravenous (IV) contrast are performed worldwide in 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 is necessary.
PURPOSE
To assess safety, diagnostic effectiveness, and baseline characteristics of patients undergoing IV gadoteric acid (Dotarem®) MRI in routine practice.
MATERIAL AND METHODS
Data from two observational post-marketing surveillance (PMS) databases compiled by 139 and 52 German centers in 2004-2011 and 2011-2013, respectively, were pooled, yielding data on a total of 148,489 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 (n = 224, 0.2%), vomiting (n = 29, <0.1%), urticaria (n = 20, <0.1%), and feeling hot (n = 13, <0.1%). AEs were considered related to gadoteric acid in 362 (0.2%) patients. Higher frequencies of AEs were observed among patients with a previous reaction to a contrast agent (2.0%), liver dysfunction (0.7%), bronchial asthma (0.7%), and a history of allergies (0.6%). There were 49 SAEs in 18 (<0.1%) patients, including two children. No fatal SAE was reported. Examinations were diagnostic in 99.8% of all patients, 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.
Magnetic resonance imaging (MRI) examinations with intravenous (IV) contrast are performed worldwide in 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 is necessary.
PURPOSE
To assess safety, diagnostic effectiveness, and baseline characteristics of patients undergoing IV gadoteric acid (Dotarem®) MRI in routine practice.
MATERIAL AND METHODS
Data from two observational post-marketing surveillance (PMS) databases compiled by 139 and 52 German centers in 2004-2011 and 2011-2013, respectively, were pooled, yielding data on a total of 148,489 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 (n = 224, 0.2%), vomiting (n = 29, <0.1%), urticaria (n = 20, <0.1%), and feeling hot (n = 13, <0.1%). AEs were considered related to gadoteric acid in 362 (0.2%) patients. Higher frequencies of AEs were observed among patients with a previous reaction to a contrast agent (2.0%), liver dysfunction (0.7%), bronchial asthma (0.7%), and a history of allergies (0.6%). There were 49 SAEs in 18 (<0.1%) patients, including two children. No fatal SAE was reported. Examinations were diagnostic in 99.8% of all patients, 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.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1177/0284185119883390
- PMID 31739672
- Persistent URL
- https://sonar.ch/global/documents/6168
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