Document Detail


Change in use of gadolinium-enhanced magnetic resonance studies in kidney disease patients after US Food and Drug Administration warnings: a cross-sectional study of Veterans Affairs Health Care System data from 2005-2008.
MedLine Citation:
PMID:  20580477     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Exposure to gadolinium in patients with kidney disease has been linked to risk of developing nephrogenic systemic fibrosis. The US Food and Drug Administration (FDA) has issued warnings against the use of gadolinium in this population. We studied the impact of these warnings on the use of gadolinium-enhanced magnetic resonance (GE-MR) studies in patients with decreased estimated glomerular filtration rate (eGFR) and the practice of measuring serum creatinine before gadolinium exposure. STUDY DESIGN: Cross-sectional study of patients who had undergone MR studies from October 2002 to September 2008. SETTING & PARTICIPANTS: Patients receiving medical care in the US Department of Veterans Affairs Health Care System. PREDICTOR: Date of MR imaging, serum creatinine level, and eGFR using the 4-variable Modification of Diet in Renal Disease (MDRD) Study equation. OUTCOMES & MEASUREMENTS: The rate of MR studies performed with and without gadolinium from July 2005 to September 2008 in patients with different stages of kidney disease, defined using eGFR. The proportion of GE-MR studies with a screening serum creatinine level. RESULTS: There was a 71% decrease in the rate of GE-MR use in patients with GFR<30 mL/min/1.73 m2 2 years after the release of the first public health advisory, although studies continued to be performed in patients with stages 4 and 5 chronic kidney disease. The proportion of GE-MR studies with serum creatinine measured within 1 month before the study increased by 99%. LIMITATIONS: Data available up to September 30, 2008. Indications for the GE-MR studies were not assessed. The accuracy of Current Procedural Terminology and International Classification of Diseases, Ninth Revision coding was not assessed. CONCLUSION: There was a large decrease in the use of GE-MR studies in patients with GFR<30 mL/min/1.73 m2 and a large but not universal increase in the practice of measuring serum creatinine before GE-MR after the release of the FDA warnings.
Authors:
Kyung-Ho Kim; Jennifer R Fonda; Elizabeth V Lawler; David Gagnon; James S Kaufman
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Publication Detail:
Type:  Journal Article     Date:  2010-06-26
Journal Detail:
Title:  American journal of kidney diseases : the official journal of the National Kidney Foundation     Volume:  56     ISSN:  1523-6838     ISO Abbreviation:  Am. J. Kidney Dis.     Publication Date:  2010 Sep 
Date Detail:
Created Date:  2010-08-23     Completed Date:  2010-09-23     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8110075     Medline TA:  Am J Kidney Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  458-67     Citation Subset:  IM    
Copyright Information:
Copyright (c) 2010 National Kidney Foundation, Inc. All rights reserved.
Affiliation:
Renal Section, State University of New York at Stony Brook, Stony Brook, NY 11794, USA. kykkim@notes.cc.sunysb.edu
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Adverse Drug Reaction Reporting Systems*
Aged
Aged, 80 and over
Contrast Media* / adverse effects
Creatinine / blood
Cross-Sectional Studies
Databases, Factual
Drug Utilization / statistics & numerical data
Female
Gadolinium* / adverse effects
Glomerular Filtration Rate
Guideline Adherence / statistics & numerical data*
Humans
Kidney Diseases* / blood,  physiopathology
Magnetic Resonance Imaging*
Male
Middle Aged
United States
United States Department of Veterans Affairs
United States Food and Drug Administration*
Young Adult
Chemical
Reg. No./Substance:
0/Contrast Media; 60-27-5/Creatinine; 7440-54-2/Gadolinium
Comments/Corrections
Comment In:
Am J Kidney Dis. 2010 Sep;56(3):427-30   [PMID:  20728788 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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