Adverse Events to the Gadolinium-based Contrast Agent Gadoxetic Acid: Systematic Review and Meta-Analysis.

Contrast Media / adverse effects Drug Hypersensitivity / etiology Gadolinium DTPA / adverse effects Humans Hypersensitivity, Immediate / etiology Magnetic Resonance Imaging Nephrogenic Fibrosing Dermopathy / chemically induced Renal Insufficiency / complications

Journal

Radiology
ISSN: 1527-1315
Titre abrégé: Radiology
Pays: United States
ID NLM: 0401260

Informations de publication

Date de publication:
12 2020
Historique:
pubmed: 27 5 2020
medline: 29 12 2020
entrez: 27 5 2020
Statut: ppublish

Résumé

Background Gadoxetic acid is classified by the American College of Radiology as a group III gadolinium-based contrast agent (GBCA), which indicates that there are limited data regarding nephrogenic systemic fibrosis (NSF) risk, but there are few if any unconfounded cases of NSF. Purpose To perform a systematic review and meta-analysis of gadoxetic acid adverse events, including immediate hypersensitivity reactions, NSF, and intracranial gadolinium retention. Materials and Methods Original research studies, case series, and case reports that reported adverse events in patients undergoing gadoxetic acid-enhanced MRI were searched in MEDLINE (1946-2019), Embase (1947-2019), CENTRAL (March 2019), and Scopus (1946-2019). The study protocol was registered at Prospero (number 162811). Risk of bias was evaluated by using Quality Assessment of Diagnostic Accuracy Studies-2, or QUADAS-2. Meta-analysis of proportions was performed by using random-effects modeling. Upper bound of 95% confidence interval (CI) for risk of NSF was determined. Results Seventy-one studies underwent full-text review. From 17 studies reporting 14 850 administrations, hypersensitivity reactions occurred in 0.3% (31 of 14 850; 95% CI: 0.2%, 0.4%) with zero deaths. From four studies reporting 106 administrations in patients with stage 4 or 5 chronic kidney disease or undergoing dialysis, the upper bound 95% CI for the risk of NSF was 2.8%. Five studies evaluating intracranial retention of gadolinium after gadoxetic acid administration were at high risk of bias. Conclusion Gadoxetic acid had a similar safety profile to American College of Radiology group 2 gadolinium-based contrast agents for hypersensitivity reactions and nephrogenic systemic fibrosis (NSF) but had lower confidence for risk of NSF because of fewer administrations in patients with severe kidney impairment. There is incomplete information documenting intracranial gadolinium retention in patients administered gadoxetic acid. © RSNA, 2020

Identifiants

DOI: 10.1148/radiol.2020200073 PMID: 32452732
pubmed: 32452732
doi: 10.1148/radiol.2020200073
doi:

Substances chimiques

Contrast Media 0
gadolinium ethoxybenzyl DTPA 0
Gadolinium DTPA K2I13DR72L

Types de publication

Journal Article Meta-Analysis Systematic Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

565-572

Auteurs

Nicola Schieda (N)

From the Department of Medical Imaging, The Ottawa Hospital, 1053 Carling Ave, Room C159, Ottawa, ON, Canada K1Y 4E9 (N.S., D.W.); Department of Diagnostic Imaging, Juravinski Cancer Centre, Hamilton, Canada (C.B.v.d.P.); Clinical Research Unit, Children's Hospital of Eastern Ontario, Ottawa, Canada (A.K.T.); Department of Radiology, Sunnybrook Health Sciences Centre, Toronto, Canada (P.J.M.); Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY (S.W.); and Department of Radiology, University of Michigan Medical Center, Ann Arbor, Mich (M.S.D.).
ORCID: 0000-0002-2653-4786

Christian B van der Pol (CB)

From the Department of Medical Imaging, The Ottawa Hospital, 1053 Carling Ave, Room C159, Ottawa, ON, Canada K1Y 4E9 (N.S., D.W.); Department of Diagnostic Imaging, Juravinski Cancer Centre, Hamilton, Canada (C.B.v.d.P.); Clinical Research Unit, Children's Hospital of Eastern Ontario, Ottawa, Canada (A.K.T.); Department of Radiology, Sunnybrook Health Sciences Centre, Toronto, Canada (P.J.M.); Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY (S.W.); and Department of Radiology, University of Michigan Medical Center, Ann Arbor, Mich (M.S.D.).
ORCID: 0000-0002-1718-2619

Daniel Walker (D)

From the Department of Medical Imaging, The Ottawa Hospital, 1053 Carling Ave, Room C159, Ottawa, ON, Canada K1Y 4E9 (N.S., D.W.); Department of Diagnostic Imaging, Juravinski Cancer Centre, Hamilton, Canada (C.B.v.d.P.); Clinical Research Unit, Children's Hospital of Eastern Ontario, Ottawa, Canada (A.K.T.); Department of Radiology, Sunnybrook Health Sciences Centre, Toronto, Canada (P.J.M.); Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY (S.W.); and Department of Radiology, University of Michigan Medical Center, Ann Arbor, Mich (M.S.D.).
ORCID: 0000-0001-7286-5474

Anne K Tsampalieros (AK)

From the Department of Medical Imaging, The Ottawa Hospital, 1053 Carling Ave, Room C159, Ottawa, ON, Canada K1Y 4E9 (N.S., D.W.); Department of Diagnostic Imaging, Juravinski Cancer Centre, Hamilton, Canada (C.B.v.d.P.); Clinical Research Unit, Children's Hospital of Eastern Ontario, Ottawa, Canada (A.K.T.); Department of Radiology, Sunnybrook Health Sciences Centre, Toronto, Canada (P.J.M.); Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY (S.W.); and Department of Radiology, University of Michigan Medical Center, Ann Arbor, Mich (M.S.D.).
ORCID: 0000-0001-8361-4419

Pejman J Maralani (PJ)

From the Department of Medical Imaging, The Ottawa Hospital, 1053 Carling Ave, Room C159, Ottawa, ON, Canada K1Y 4E9 (N.S., D.W.); Department of Diagnostic Imaging, Juravinski Cancer Centre, Hamilton, Canada (C.B.v.d.P.); Clinical Research Unit, Children's Hospital of Eastern Ontario, Ottawa, Canada (A.K.T.); Department of Radiology, Sunnybrook Health Sciences Centre, Toronto, Canada (P.J.M.); Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY (S.W.); and Department of Radiology, University of Michigan Medical Center, Ann Arbor, Mich (M.S.D.).
ORCID: 0000-0001-9975-4379

Sungmin Woo (S)

From the Department of Medical Imaging, The Ottawa Hospital, 1053 Carling Ave, Room C159, Ottawa, ON, Canada K1Y 4E9 (N.S., D.W.); Department of Diagnostic Imaging, Juravinski Cancer Centre, Hamilton, Canada (C.B.v.d.P.); Clinical Research Unit, Children's Hospital of Eastern Ontario, Ottawa, Canada (A.K.T.); Department of Radiology, Sunnybrook Health Sciences Centre, Toronto, Canada (P.J.M.); Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY (S.W.); and Department of Radiology, University of Michigan Medical Center, Ann Arbor, Mich (M.S.D.).
ORCID: 0000-0001-8459-8369

Matthew S Davenport (MS)

From the Department of Medical Imaging, The Ottawa Hospital, 1053 Carling Ave, Room C159, Ottawa, ON, Canada K1Y 4E9 (N.S., D.W.); Department of Diagnostic Imaging, Juravinski Cancer Centre, Hamilton, Canada (C.B.v.d.P.); Clinical Research Unit, Children's Hospital of Eastern Ontario, Ottawa, Canada (A.K.T.); Department of Radiology, Sunnybrook Health Sciences Centre, Toronto, Canada (P.J.M.); Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY (S.W.); and Department of Radiology, University of Michigan Medical Center, Ann Arbor, Mich (M.S.D.).
ORCID: 0000-0001-7943-7851

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Classifications MeSH

questionsmedicales.fr › Actions chimiques et utilisations › Utilisations spécialisées de produits chimiques › Produits de contraste › Adverse Events to the Gadolinium-based...
questionsmedicales.fr › Troubles dus à des produits chimiques › Effets secondaires indésirables des médicaments › Hypersensibilité médicamenteuse › Adverse Events to the Gadolinium-based...
questionsmedicales.fr › Composés chimiques organiques › Complexes de coordination › Acide gadopentétique › Adverse Events to the Gadolinium-based...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Adverse Events to the Gadolinium-based...
questionsmedicales.fr › Maladies du système immunitaire › Hypersensibilité › Hypersensibilité immédiate › Adverse Events to the Gadolinium-based...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Imagerie diagnostique › Tomographie › Imagerie par résonance magnétique › Adverse Events to the Gadolinium-based...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Fibrose › Fibrose systémique néphrogénique › Adverse Events to the Gadolinium-based...
questionsmedicales.fr › Maladies urogénitales › Maladies urologiques › Maladies du rein › Insuffisance rénale › Adverse Events to the Gadolinium-based...