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Safety of Gadobutrol in Over 23,000 Patients: the GARDIAN Study, a Global Multicentre, Prospective, Non-Interventional Study

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Safety of Gadobutrol in Over 23,000 Patients: the GARDIAN Study, a Global Multicentre, Prospective, Non-Interventional Study Eur Radiol DOI 10.1007/s00330-016-4268-8 MAGNETIC RESONANCE Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study Martin R. Prince1,14 & Hae Giu Lee2 & Chang-Hee Lee3 & Sung Won Youn 4 & In Ho Lee5 & Woong Yoon6 & Benqiang Yang7 & Haiping Wang8 & Jin Wang9 & Tiffany Ting-fang Shih10 & Guo-Shu Huang11 & Jiing-Feng Lirng12 & Petra Palkowitsch 13 & on behalf of the GARDIAN study group Received: 3 September 2015 /Revised: 19 January 2016 /Accepted: 2 February 2016 # The Author(s) 2016. This article is published with open access at Springerlink.com Abstract serious adverse events, four were drug-related. One patient Objectives To investigate the safety and tolerability of gado- experienced a fatal anaphylactoid shock, assessed to be related butrol at the recommended dose in patients requiring contrast- to injection of gadobutrol. The contrast quality of gadobutrol- enhanced magnetic resonance imaging/angiography (MRI/ enhanced images was rated by treating physicians as good or MRA) in the routine setting. excellent in 97 % cases, with similar ratings in all patient Methods GARDIAN prospectively enrolled 23,708 patients subgroups and indications. undergoing routine gadobutrol-enhanced MRI/MRA for ap- Conclusions The GARDIAN study shows that gadobutrol at proved indications at 272 study centres in Europe, Asia, North the recommended dose is well tolerated across a large, diverse America, and Africa and monitored for adverse events. patient population. Results Median gadobutrol dose was 0.11 mmol/kg body Key points weight. The overall incidence of adverse drug reactions • Gadobutrol at recommended dose shows low rates of ad- (ADRs) was 0.7 % (n = 170 patients), with similar incidences verse drug reactions in patients with renal impairment or cardiac disease, from • Gadobutrol demonstrates a uniform safety profile across different geographic regions and in different gadobutrol dose diverse patient groups groups. Patients at risk for contrast media reaction had an • Gadobutrol provides excellent contrast quality in routine ADR incidence of 2.5 %. Five patients (0.02 %) experienced practice * Martin R. Prince 7 Department of Radiology, General Hospital of Shenyang Military [email protected] Region, Shenyang, China 8 ’ on behalf of the GARDIAN study group Department of Radiology, Tangshan Worker sHospital, Tangshan, China 9 1 Department of Radiology, Weill Cornell Medical College, 416 east Department of Radiology, Third Affiliated Hospital of Sun Yat-Sen 55th Street, New York, NY 10022, USA University, Guangzhou, China 2 Department of Radiology, Seoul St. Mary’s Hospital, The Catholic 10 Department of Radiology and Medical Imaging, National Taiwan University of Korea, College of Medicine, Seoul, South Korea University, Medical College and Hospital, Taipei, Taiwan 3 Department of Radiology, Korea University Guro Hospital, 11 Department of Radiology, Tri-Service General Hospital, National Seoul, South Korea Defense Medical Center, Taipei, Taiwan 4 Department of Radiology, Catholic University of Daegu Medical 12 Department of Radiology, Taipei Veterans General Hospital, Center, Daegu, South Korea Taipei, Taiwan 5 Department of Radiology, Chungnam National University Hospital, 13 Chungnam National University School of Medicine, Daejeon, South Medical & Clinical Affairs Radiology, Bayer Pharmaceutical Korea Division, Berlin, Germany 6 Department of Radiology, Chonnam National University Hospital, 14 Department of Radiology, Columbia College of Physicians and Gwangju, South Korea Surgeons, New York, NY 10021, USA Eur Radiol Keywords Adverse drug reaction . Contrast media . practice, including the age group 2 to 7 years as well as pa- Gadobutrol . Magnetic resonance imaging . Safety tients with renal impairment or cardiac disease and patients considered at risk for contrast media (CM) reactions. Abbreviations Methods ADR Adverse drug reaction BW Body weight Trial design CM Contrast medium GARDIAN Gadovist® in Routine Diagnostic MRI – GARDIAN was a phase IV, non-interventional, prospective, Administration in Non-selected Patients multicentre, post-authorization safety study (PASS). The GBCA Gadolinium-based contrast agents study was conducted between August 2010 and April Gd3+ Gadolinium ion 2013 at 272 study centres in 17 countries in Africa, Asia, MedDRA Medical Dictionary for Regulatory Activities Europe, and North America (NCT01095081). The study pro- MRA Magnetic resonance angiography tocol was approved by local ethics committees/institutional MRI Magnetic resonance imaging review boards at the respective study sites and was conducted NSF Nephrogenic systemic fibrosis in accordance with ethical principles consistent with the SAE Serious adverse event Declaration of Helsinki and the International Conference of Harmonisation guidelines, Good Clinical Practice (ICH- GCP). The study adhered to guidelines of the EMA, the US Introduction Food and Drug Administration (FDA) [16, 17], local laws and regulations. Each patient provided written informed consent Gadolinium-based contrast agents (GBCAs) enhance tis- prior to study enrolment. sue contrast in magnetic resonance imaging (MRI) and are an essential tool for diagnosis in a range of indications [1, Participants 2]. Gadobutrol (Gd-DO3A-butrol, Gadovist®, Gadavist®) is a non-ionic, macrocyclic GBCA with high T1-relaxivity Male or female adults and children who were scheduled to and is marketed as a 1 mmol/mL gadolinium concentra- undergo cranial or spinal MRI, liver or kidney MRI or MRA tion [3, 4]. The higher-concentration formulation of gad- with gadobutrol enhancement were eligible for enrolment. obutrol compared to almost all other marketed GBCAs There were no exclusion criteria beyond the contraindications (typically 0.5 mmol/mL) may theoretically influence the in the Summary of Product Characteristics for Gadovist (i.e. diagnostic efficacy of the compound in first-pass dynamic hypersensitivity to the active substance or to any of the techniques, since the higher concentration alters delivery excipients). of gadolinium [5, 6]. Doses of gadobutrol up to 0.3 mmol/ Patients received medicinal products according to standard kg BW are approved in some regions for specific indica- clinical practice, with no additional diagnostic or monitoring tions in adults. Gadobutrol rapidly distributes into the ex- processes as a result of study participation. Patients with mod- tracellular space following infusion and is eliminated in- erate or severe renal impairment (estimated glomerular filtra- tact by glomerular filtration [7]. tion rate [eGFR] 30–59 and <30 mL/min/1.73 m2,respective- The macrocyclic chemical structure contributes to the high ly) were scheduled for follow-up investigation after 3 months, kinetic stability of gadobutrol [8] compared with linear con- at the discretion of the treating physician and in accordance trast agents [9], and is associated with a lower propensity to with routine practice. Any skin reactions suggestive of NSF release gadolinium ions (Gd3+). European, US, and other were compulsorily followed up as potential AEs. guidelines categorize gadobutrol within the lowest risk cate- gory for nephrogenic systemic fibrosis (NSF) [1, 10–12]. Outcome measures Clinical and observational studies on a range of indications in adults and children have demonstrated gadobutrol to be Patient demographics, medical data (concomitant diseases and efficacious with a favourable safety and tolerability profile treatments), contrast agent risk factors (including previous [13–15]. At the request of the European Medicines Agency CM reactions), as well as any signs and symptoms or treat- (EMA), a prospective, multicentre, non-interventional study, ments administered for contrast reactions were documented GARDIAN (Gadovist® in Routine Diagnostic MRI – by the treating physician or nurse in case report forms at the Administration in Non-selected Patients), was initiated to time of MRI. Information on the CM intravenous injection evaluate the acute safety and tolerability of gadobutrol use in (dose, amount) and subjective assessment of contrast- approved indications in a large patient population in routine enhanced image quality were also recorded. Eur Radiol The primary study endpoint was the overall incidence of relationship, seriousness, and outcome. Event rates for adverse drug reactions (ADRs) and serious adverse events AEs/ADRs in patients were calculated as a proportion of (SAEs) following gadobutrol administration, including the the study population. Analyses were performed on the rates, severity, and symptoms of events. Adverse events total study population (pooled analysis) and in at-risk pa- (AEs) documented by the treating physician or nurse were tient subgroups. Geographic regions were analysed by categorized as ADRs based on the judgment of the treating pooling countries into three groups: Asia, Europe, and physician. SAEs were defined as events that are medically BOther^ (Canada and South Africa). important, life-threatening, fatal, or involved hospitalization Safety analyses were performed on the safety popula- or prolongation of current hospitalization, disability/incapaci- tion, which included all subjects assigned to treatment ty, or birth defects. who received at least one dose of gadobutrol. The efficacy Secondary study endpoints were the rates, quality, and population included all subjects who underwent MRI/ symptoms of AEs and ADRs associated with gadobutrol in MRA scans with gadobutrol injection.
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