Patterns of use, effectiveness and safety of gadolinium contrast agents: a European prospective cross-sectional multicentre observational study

• Published in: BMC medical imaging 2021-04, Vol.21 (1), p.74-74, Article 74
• Main Authors: Jakobsen, Jarl Åsbjørn, Quattrocchi, Carlo Cosimo, Müller, Frank H H, Outteryck, Olivier, Alcázar, Andrés, Reith, Wolfgang, Fraga, Patricia, Panebianco, Valeria, Sampedro, Alexis, Pietura, Radoslaw
• Format: Article
• Language: English
• Subjects: Adult; Adverse events; Aged; Body mass index; Body weight; Clinical medicine; Comorbidity; Confidence; Contrast agents; Contrast media; Contrast Media - administration & dosage; Contrast Media - adverse effects; Cross-Sectional Studies; Dextrans - administration & dosage; Dextrans - adverse effects; Diagnosis; Diagnostic confidence; Diagnostic systems; Drugs; Europe; Female; Gadobutrol; Gadolinium; Gadolinium - administration & dosage; Gadolinium - adverse effects; Heterocyclic Compounds - administration & dosage; Heterocyclic Compounds - adverse effects; Humans; Image quality; Life Sciences; Magnetic resonance; Magnetic resonance imaging; Magnetic Resonance Imaging - methods; Magnetite Nanoparticles - administration & dosage; Magnetite Nanoparticles - adverse effects; Male; Marketing; Medical diagnosis; Medical imaging; Medical research; Medicine, Experimental; Meglumine - administration & dosage; Meglumine - adverse effects; Middle Aged; Observational studies; Organometallic Compounds - administration & dosage; Organometallic Compounds - adverse effects; Patients; Prospective Studies; Safety; Safety and security measures; Young Adult
• ISSN: 1471-2342; 1471-2342
• DOI: 10.1186/s12880-021-00600-9

The EU gadolinium-based contrast agents (GBCA) market has changed in recent years due to the European Medicines Agency decision to suspend the marketing authorisation of linear GBCA and the marketing authorisation of new generic macrocyclic GBCA. The study aims to understand the patterns of (GBCA) use, and to study the effectiveness and safety of GBCA in routine practice across Europe. Prospective, cross-sectional, multicentre, observational study in patients undergoing contrast-enhanced magnetic resonance. Reported usage patterns included indication, referral and examination details. Assessment of effectiveness included changes in radiological diagnosis, diagnostic confidence and image quality. Safety data were collected by spontaneous patient adverse event (AE) reporting. 2118 patients were included from 8 centres across 5 European countries between December 2018 and November 2019. Clariscan, Dotarem (gadoteric acid), Gadovist (gadobutrol) and ProHance (gadoteridol) were utilised in 1513 (71.4%), 356 (16.8%), 237 (11.2%) and 12 (0.6%) patients, respectively. Most were performed in CNS-related indications (46.2%). Mean GBCA doses were 0.10 mmol/kg body weight, except for Gadovist (mean 0.12 mmol/kg). GBCA use increased confidence in diagnosis in 96.2% of examinations and resulted in a change in radiological diagnosis in 73.9% of patients. Image quality was considered excellent or good in 96.1% of patients and across all GBCA. Four patients reported AEs (0.19%), with only 1 (0.05%) considered serious. This European study confirmed that GBCAs are used appropriately in Europe for a wide range of indications. The study demonstrated a significant increase in diagnostic confidence after GBCA use and confirmed the good safety profile of GBCAs, with comparable results for all agents used.