Risk for Nephrogenic Systemic Fibrosis with Gadoteridol (ProHance) in Patients Who Are on Long-Term Hemodialysis

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Abstract
Background and objectives: Recent studies strongly link nephrogenic systemic fibrosis to gadolinium administration for magnetic resonance imaging. In a recent advisory, the Food and Drug Administration stated that all gadolinium-containing chelates are potentially associated with nephrogenic systemic fibrosis; however, most reported cases are linked to gadodiamide (Omniscan) and gadopentetate dimeglumine (Magnevist). Given the severe consequences of nephrogenic systemic fibrosis, it is critical to define the risks associated with each gadolinium-containing chelate. The purpose of this study was to examine nephrogenic systemic fibrosis risk in a hemodialysis population exposed to gadoteridol (ProHance). Design, setting, participants, & objectives: Appointment logs were used to generate a database of all long-term hemodialysis patients at the Dallas Veterans Affairs hospital since August 2001. These patients were then examined in the Veterans Affair's electronic medical record system for gadolinium exposure during magnetic resonance imaging from 2000 through 2007, a period during which gadoteridol was the sole contrast agent used. Results: A total of 141 patients were identified with 198 gadoteridol exposures. No cases of nephrogenic systemic fibrosis were identified. The observed frequency of nephrogenic systemic fibrosis was compared with the expected frequency (2.4%) using one-way χ2 and binomial analysis, yielding a P < 0.05, indicating that the result was not explained by chance alone. Conclusions: It is concluded that the risk for nephrogenic systemic fibrosis with gadoteridol in patients who are on long-term hemodialysis may be lower than with gadodiamide and gadopentetate dimeglumine.