TY  - JOUR
A1  - Michaely, Henrik J.
A1  - Aschauer, Manuela
A1  - Deutschmann, Hannes
A1  - Bongartz, Georg
A1  - Gutberlet, Matthias
A1  - Woitek, Ramona
A1  - Ertl-Wagner, Birgit
A1  - Kucharczyk, Walter
A1  - Hammerstingl, Renate Maria
A1  - De Cobelli, Francesco
A1  - Rosenberg, Martin
A1  - Balzer, Thomas
A1  - Endrikat, Jan
T1  - Gadobutrol in renally impaired patients : results of the GRIP study
T2  - Investigative radiology
N2  - Objective: The aim of this study was to assess the potential risk of gadobutrol-enhanced magnetic resonance imaging (MRI) in patients with moderate to severe renal impairment for the development of nephrogenic systemic fibrosis (NSF).
Materials and Methods: We performed a prospective, international, multicenter, open-label study in 55 centers. Patients with moderate to severe renal impairment scheduled for any gadobutrol-enhanced MRI were included. All patients received a single intravenous bolus injection of gadobutrol at a dose of 0.1 mmol/kg body weight. The primary target variable was the number of patients who develop NSF within a 2-year follow-up period.
Results: A total of 908 patients were enrolled, including 586 with moderate and 284 with severe renal impairment who are at highest risk for developing NSF. The mean time since renal disease diagnosis was 1.83 and 5.49 years in the moderate and severe renal impairment cohort, respectively. Overall, 184 patients (20.3%) underwent further contrast-enhanced MRI with other gadolinium-based contrast agents within the 2-year follow-up. No patient developed symptoms conclusive of NSF.
Conclusions: No safety concerns with gadobutrol in patients with moderate to severe renal impairment were identified. There were no NSF cases.
KW  - gadobutrol
KW  - renal impairment
KW  - NSF
Y1  - 2016
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/42718
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-427182
SN  - 0020-9996
N1  - Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
VL  - 52.2017
IS  - 1
SP  - 55
EP  - 60
PB  - Lippincott Williams & Wilkins
CY  - Philadelphia, Pa.
ER  -