Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study

Abstract

ObjectivesTo investigate the safety and tolerability of gadobutrol at the recommended dose in patients requiring contrast-enhanced magnetic resonance imaging/angiography (MRI/MRA) in the routine setting.MethodsGARDIAN prospectively enrolled 23,708 patients undergoing routine gadobutrol-enhanced MRI/MRA for approved indications at 272 study centres in Europe, Asia, North America, and Africa and monitored for adverse events.ResultsMedian gadobutrol dose was 0.11 mmol/kg body weight. The overall incidence of adverse drug reactions (ADRs) was 0.7 % (n = 170 patients), with similar incidences in patients with renal impairment or cardiac disease, from different geographic regions and in different gadobutrol dose groups. Patients at risk for contrast media reaction had an ADR incidence of 2.5 %. Five patients (0.02 %) experienced serious adverse events, four were drug-related. One patient experienced a fatal anaphylactoid shock, assessed to be related to injection of gadobutrol. The contrast quality of gadobutrol-enhanced images was rated by treating physicians as good or excellent in 97 % cases, with similar ratings in all patient subgroups and indications.ConclusionsThe GARDIAN study shows that gadobutrol at the recommended dose is well tolerated across a large, diverse patient population.Key points• Gadobutrol at recommended dose shows low rates of adverse drug reactions • Gadobutrol demonstrates a uniform safety profile across diverse patient groups • Gadobutrol provides excellent contrast quality in routine practice

Use of contrast media in computed tomography and magnetic resonance imaging in horses: Techniques, adverse events and opportunities

“…In man, headache, nausea, vomiting and hives are reported though these events may be related to the primary disease or MRI noise [249]. The rates of adverse events after GCM administration in man are similar among agents [11,[251][252][253], although gadoteridol appears to have the lowest risk [252]. The rates of adverse events after GCM administration in man are similar among agents [11,[251][252][253], although gadoteridol appears to have the lowest risk [252].…”

“…In man, adverse events with GCM are less common than with ICM [250], but can still be fatal [136,249]. The rates of adverse events after GCM administration in man are similar among agents [11,[251][252][253], although gadoteridol appears to have the lowest risk [252]. In man, moderate and severe reactions encompass <1% of all adverse events [254,255].…”

A guide for effective anatomical vascularization studies: useful ex vivo methods for both CT and MRI imaging before dissection

“…The macrocyclic chemical structure contributes to the high kinetic stability of gadobutrol compared with linear contrast agents, and is associated with a lower propensity to release gadolinium ions (Prince et al. ). Gadobutrol is known to be less likely to diffuse throughout tissues and microvasculature (Helms et al.…”

Gadobutrol in India—A Comprehensive Review of Safety and Efficacy

“…General safety of gadobutrol has been assessed in 6809 patients from 42 clinical phase 2 to 4 studies, 13 in 7 prospective observational studies, 9 , 14 and by analyzing pharmacovigilance data comprising 29 million applications. 13 However, a direct safety comparison of different GBCAs is challenging, as no head-to-head prospective studies are available.…”

“… 6 The stability of Gd chelates has been linked to an increased risk of nephrogenic systemic fibrosis (NSF) in patients with severely impaired renal function. 7 , 8 Because of these favorable characteristics, gadobutrol was categorized as a low-risk GBCA for development of NSF by several medical organizations 5 , 9 and authorities. 10 – 12…”