Abstract
BackgroundThe 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.MethodsProspective, 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.Results2118 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.ConclusionsThis 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.
Highlights
The European Union (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 Gadolinium-based contrast agents (GBCAs) and the marketing authorisation of new generic macrocyclic GBCA
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
Summary
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. Gadolinium-based contrast agents (GBCAs) have been used in over 450 million patients worldwide since their introduction in 1988, and are the main agents used for CE-MR [1]. GBCAs can be Jakobsen et al BMC Med Imaging (2021) 21:74 differentiated based on chelate chemistry, stability, ionicity, viscosity, osmolality and relaxivity, and according to their effectiveness for specific applications [2]. Defining the indications that require contrast enhancement in clinical practice is often subject to local variability in factors, such as availability of resources, local protocols and expertise, patient expectations, and financial pressures and constraints. These can all affect whether the use of contrast agents is considered
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