Nephrogenic systemic fibrosis: change in incidence following a switch in gadolinium agents and adoption of a gadolinium policy--report from two U.S. universities.
OBJECTIVE
To determine the incidence of nephrogenic systemic fibrosis (NSF) in tertiary care centers of two U.S. universities following the switch from the use of gadodiamide to gadobenate dimeglumine and gadopentetate dimeglumine, and the adoption of restrictive gadolinium-based contrast agent (GBCA) policies.


METHODS
Institutional review board approval with waiver of informed consent was obtained for this Health Insurance Portability and Accountability Act-compliant retrospective study. NSF patients were identified between January 2000 and December 2006 at center A and between October 2003 and February 2007 at center B (preadoption periods); and from June 2007 to June 2008 at both centers (postadoption period). The numbers of patients who underwent gadolinium-enhanced magnetic resonance at each center, patients at risk for NSF at center A, and dialysis patients at center B were identified in the pre- and postadoption periods. Gadodiamide was the only agent used in the preadoption period. Gadobenate dimeglumine and gadopentetate dimeglumine were the agents used in the postadoption period. A restrictive GBCA policy that limits the use and dose of GBCAs in patients with risk factors was adopted in the postadoption period. Follow-up lasted 9 months from July 2008 to March 2009. Corresponding incidences were determined and compared with the Fisher exact test.


RESULTS
Respective total benchmark incidence of NSF at both centers, at-risk incidence of NSF at center A, and dialysis incidence of NSF at center B were 37 of 65 240, 28 of 925, and nine of 312 in the preadoption period and zero of 25 167, zero of 147, and zero of 402 in the postadoption period. All three incidences demonstrated significant differences (P < .0001, .024, and .001, respectively) between the pre- and postadoption periods.


CONCLUSIONS
Following the switch from gadodiamide to gadobenate dimeglumine and gadopentetate dimeglumine, and the adoption of restrictive GBCA policies, no NSF cases were observed at either center.
Department of Radiology, School of Medicine, University of North Carolina at Chapel Hill, 101 Manning Dr, CB 7510, Chapel Hill, NC 27599-7510, USA.
Ersan
E
Altun
Diego R
DR
Martin
Rebecca
R
Wertman
Aida
A
Lugo-Somolinos
Edwin R
ER
Fuller
Richard C
RC
Semelka
D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D019786:Gadolinium DTPA / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D008279:Magnetic Resonance Imaging; D008297:Male; D008536:Meglumine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D008875:Middle Aged; D054989:Nephrogenic Fibrosing Dermopathy / Q000139:chemically induced* / Q000453:epidemiology* / Q000628:therapy; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000009:adverse effects*; D006435:Renal Dialysis; D012189:Retrospective Studies; D012307:Risk Factors; D014481:United States / Q000453:epidemiology
D003287:Contrast Media; D009942:Organometallic Compounds; C064572:gadobenic acid; D008536:Meglumine; C064925:gadodiamide; D019786:Gadolinium DTPA