Gilles Soulez1, Daniel C Bloomgarden2,3, Neil M Rofsky4,5, Martin P Smith4, Hani H Abujudeh6, Desiree E Morgan7, Richard J Lichtenstein8, Mark L Schiebler9, Franz J Wippold10, Craig Russo11, Matthew J Kuhn12,13, Kevin W Mennitt14, Jeffrey H Maki15,16, Alan Stolpen17, Johnson Liou18, Richard C Semelka19, Miles A Kirchin20, Ningyan Shen21, Gianpaolo Pirovano21, Alberto Spinazzi21. 1. 1 Centre Hospitalier de l'Université de Montreal-Notre Dame Hospital, Montreal, Canada. 2. 2 Milwaukee Radiologists Ltd., St. Luke's Medical Center, Milwaukee, WI. 3. 3 Present address: Milwaukee Radiologists Ltd., St. Joseph's Hospital, Milwaukee, WI. 4. 4 Department of Radiology, Beth Israel Deaconess Medical Center, Boston, MA. 5. 5 Present address: Department of Radiology, University of Texas Southwestern Medical Center, Dallas, TX. 6. 6 Department of Radiology, Massachusetts General Hospital, Boston, MA. 7. 7 Department of Radiology, University of Alabama School of Medicine, Birmingham, AL. 8. 8 Department of Radiology, Sarasota Memorial Hospital, Sarasota, FL. 9. 9 Department of Radiology, University of Wisconsin-Madison School of Medicine and Public Health, Madison, WI. 10. 10 Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO. 11. 11 Clinical Radiologists, S.C., Springfield, IL. 12. 12 Department of Radiology, St. John's Hospital, Springfield, IL. 13. 13 Present address: Department of Radiology, University of Illinois College of Medicine, Peoria, IL. 14. 14 Diagnostic Radiology, Weill Cornell Medical College, New York, NY. 15. 15 Department of Radiology, Veterans Affairs Puget Sound Health Care System, Seattle, WA. 16. 16 Present address: Department of Radiology, University of Washington Medical Center, Seattle, WA. 17. 17 Department of Radiology, University of Iowa Hospitals and Clinics, Iowa City, IA. 18. 18 Radiology Associates of Atlanta, Atlanta, GA. 19. 19 Department of Radiology, University of North Carolina at Chapel Hill, Chapel Hill, NC. 20. 20 Bracco Imaging S.p.A, Global Medical and Regulatory Affairs, Via Caduti di Marcinelle 13, Milan 20134, Italy. 21. 21 Bracco Diagnostics Inc., Global Medical and Regulatory Affairs, Monroe Township, NJ.
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 moderate-to-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 m(2)) or stage 4 or 5 CKD (eGFR in cohort 2, < 30 mL/min/1.73 m(2)) 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.
OBJECTIVE: The purpose of this study was to determine the incidence of nephrogenic systemic fibrosis (NSF) in patients with chronic kidney disease (CKD) and moderate-to-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 m(2)) or stage 4 or 5 CKD (eGFR in cohort 2, < 30 mL/min/1.73 m(2)) 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.
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