Abstract
OBJECTIVE. The purpose of this study was to determine the incidence of nephrogenic systemic fibrosis (NSF) in patients with chronic kidney disease (CKD) and moderateto-severe impairment of kidney function who had not previously been exposed to gadolinium-based contrast agents (GBCAs) or referred to undergo contrast-enhanced MRI with gadobenate dimeglumine or gadoteridol. SUBJECTS AND METHODS. Two multicenter prospective cohort studies evaluated the incidence of unconfounded NSF in patients with stage 3 CKD (estimated glomerular filtration rate [eGFR] in cohort 1, 30-59 mL/min/1.73 m2) or stage 4 or 5 CKD (eGFR in cohort 2, <30 mL/min/1.73 m2) after injection of gadobenate dimeglumine (study A) or gadoteridol (study B). A third study (study C) determined the incidence of NSF in patients with stage 4 or 5 CKD who had not received a GBCA in the 10 years before enrollment. Monitoring for signs and symptoms suggestive of NSF was performed via telephone at 1, 3, 6, and 18 months, with clinic visits occurring at 1 and 2 years. RESULTS. For studies A and B, the populations evaluated for NSF comprised 363 and 171 patients, respectively, with 318 and 159 patients in cohort 1 of each study, respectively, and with 45 and 12 patients in cohort 2, respectively. No signs or symptoms of NSF were reported or detected during the 2 years of patient monitoring. Likewise, no cases of NSF were reported for any of the 405 subjects enrolled in study C. CONCLUSION. To our knowledge, and consistent with reports in the literature, no association of gadobenate dimeglumine or gadoteridol with unconfounded cases of NSF has yet been established. Study data confirm that both gadoteridol and gadobenate dimeglumine properly belong to the class of GBCAs considered to be associated with the lowest risk of NSF.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 469-478 |
| Number of pages | 10 |
| Journal | American Journal of Roentgenology |
| Volume | 205 |
| Issue number | 3 |
| DOIs | |
| State | Published - Sep 1 2015 |
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Keywords
- Gadobenate dimeglumine
- Gadoteridol
- Nephrogenic systemic fibrosis
- Prospective studies
ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging
- Medicine(all)
Cite this
Prospective cohort study of nephrogenic systemic fibrosis in patients with stage 3-5 chronic kidney disease undergoing mri with injected gadobenate dimeglumine or gadoteridol. / Soulez, Gilles; Bloomgarden, Daniel C.; Rofsky, Neil M.; Smith, Martin P.; Abujudeh, Hani H.; Morgan, Desiree E.; Lichtenstein, Richard J.; Schiebler, Mark L.; Wippold, Franz J.; Russo, Craig; Kuhn, Matthew J.; Mennitt, Kevin W.; Maki, Jeffrey H.; Stolpen, Alan; Liou, Johnson; Semelka, Richard C.; Kirchin, Miles A.; Shen, Ningyan; Pirovano, Gianpaolo; Spinazzi, Alberto.
In: American Journal of Roentgenology, Vol. 205, No. 3, 01.09.2015, p. 469-478.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Prospective cohort study of nephrogenic systemic fibrosis in patients with stage 3-5 chronic kidney disease undergoing mri with injected gadobenate dimeglumine or gadoteridol
AU - Soulez, Gilles
AU - Bloomgarden, Daniel C.
AU - Rofsky, Neil M.
AU - Smith, Martin P.
AU - Abujudeh, Hani H.
AU - Morgan, Desiree E.
AU - Lichtenstein, Richard J.
AU - Schiebler, Mark L.
AU - Wippold, Franz J.
AU - Russo, Craig
AU - Kuhn, Matthew J.
AU - Mennitt, Kevin W.
AU - Maki, Jeffrey H.
AU - Stolpen, Alan
AU - Liou, Johnson
AU - Semelka, Richard C.
AU - Kirchin, Miles A.
AU - Shen, Ningyan
AU - Pirovano, Gianpaolo
AU - Spinazzi, Alberto
PY - 2015/9/1
Y1 - 2015/9/1
N2 - OBJECTIVE. The purpose of this study was to determine the incidence of nephrogenic systemic fibrosis (NSF) in patients with chronic kidney disease (CKD) and moderateto-severe impairment of kidney function who had not previously been exposed to gadolinium-based contrast agents (GBCAs) or referred to undergo contrast-enhanced MRI with gadobenate dimeglumine or gadoteridol. SUBJECTS AND METHODS. Two multicenter prospective cohort studies evaluated the incidence of unconfounded NSF in patients with stage 3 CKD (estimated glomerular filtration rate [eGFR] in cohort 1, 30-59 mL/min/1.73 m2) or stage 4 or 5 CKD (eGFR in cohort 2, <30 mL/min/1.73 m2) after injection of gadobenate dimeglumine (study A) or gadoteridol (study B). A third study (study C) determined the incidence of NSF in patients with stage 4 or 5 CKD who had not received a GBCA in the 10 years before enrollment. Monitoring for signs and symptoms suggestive of NSF was performed via telephone at 1, 3, 6, and 18 months, with clinic visits occurring at 1 and 2 years. RESULTS. For studies A and B, the populations evaluated for NSF comprised 363 and 171 patients, respectively, with 318 and 159 patients in cohort 1 of each study, respectively, and with 45 and 12 patients in cohort 2, respectively. No signs or symptoms of NSF were reported or detected during the 2 years of patient monitoring. Likewise, no cases of NSF were reported for any of the 405 subjects enrolled in study C. CONCLUSION. To our knowledge, and consistent with reports in the literature, no association of gadobenate dimeglumine or gadoteridol with unconfounded cases of NSF has yet been established. Study data confirm that both gadoteridol and gadobenate dimeglumine properly belong to the class of GBCAs considered to be associated with the lowest risk of NSF.
AB - OBJECTIVE. The purpose of this study was to determine the incidence of nephrogenic systemic fibrosis (NSF) in patients with chronic kidney disease (CKD) and moderateto-severe impairment of kidney function who had not previously been exposed to gadolinium-based contrast agents (GBCAs) or referred to undergo contrast-enhanced MRI with gadobenate dimeglumine or gadoteridol. SUBJECTS AND METHODS. Two multicenter prospective cohort studies evaluated the incidence of unconfounded NSF in patients with stage 3 CKD (estimated glomerular filtration rate [eGFR] in cohort 1, 30-59 mL/min/1.73 m2) or stage 4 or 5 CKD (eGFR in cohort 2, <30 mL/min/1.73 m2) after injection of gadobenate dimeglumine (study A) or gadoteridol (study B). A third study (study C) determined the incidence of NSF in patients with stage 4 or 5 CKD who had not received a GBCA in the 10 years before enrollment. Monitoring for signs and symptoms suggestive of NSF was performed via telephone at 1, 3, 6, and 18 months, with clinic visits occurring at 1 and 2 years. RESULTS. For studies A and B, the populations evaluated for NSF comprised 363 and 171 patients, respectively, with 318 and 159 patients in cohort 1 of each study, respectively, and with 45 and 12 patients in cohort 2, respectively. No signs or symptoms of NSF were reported or detected during the 2 years of patient monitoring. Likewise, no cases of NSF were reported for any of the 405 subjects enrolled in study C. CONCLUSION. To our knowledge, and consistent with reports in the literature, no association of gadobenate dimeglumine or gadoteridol with unconfounded cases of NSF has yet been established. Study data confirm that both gadoteridol and gadobenate dimeglumine properly belong to the class of GBCAs considered to be associated with the lowest risk of NSF.
KW - Gadobenate dimeglumine
KW - Gadoteridol
KW - Nephrogenic systemic fibrosis
KW - Prospective studies
UR - http://www.scopus.com/inward/record.url?scp=84942693350&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84942693350&partnerID=8YFLogxK
U2 - 10.2214/AJR.14.14268
DO - 10.2214/AJR.14.14268
M3 - Article
C2 - 26295633
AN - SCOPUS:84942693350
VL - 205
SP - 469
EP - 478
JO - American Journal of Roentgenology
JF - American Journal of Roentgenology
SN - 0361-803X
IS - 3
ER -