A new systematic review appeared this week in Annals of Internal Medicine. The article is entitled, "Risk for Nephrogenic Systemic Fibrosis After Exposure to Newer Gadolinium Agents". DGIM members, Joseph Lunyera, MBChB, is the first author and Karen Goldstein, MD, the senior author.
The team conducted this study to provide a nuanced evidence base on Nephrogenic Systemic Fibrosis (NSF) risk after exposure to gadolinium agents among patients across the spectrum of kidney function.
"This nuanced approach was important because there were evidence gaps pertaining to NSF risk within certain patient subgroups, including those with acute kidney injury and those at risk for chronic kidney disease," explains Lunyera. "We found that NSF occurrence was rare after exposure to newer compared with older gadolinium-based contrast agents. However, we suggest caution in clinical decision-making because the existing data on this issue is scant among patients with acute kidney injury and chronic kidney disease risk factors (e.g., diabetes and hypertension). This evidence gap can be bridged in future investigations addressing NSF risk after gadolinium exposure specifically in these patient subgroups."
Project Summary:
Background: The risk for nephrogenic systemic fibrosis (NSF) after exposure to newer versus older gadolinium-based contrast agents (GBCAs) remains unclear.
Purpose: To synthesize evidence about NSF risk with newer versus older GBCAs across the spectrum of kidney function.
Study Selection: Randomized controlled trials, cohort studies, and case–control studies that assessed NSF occurrence after GBCA exposure.
Data Extraction: Data were abstracted by 1 investigator and verified by a second. Investigator pairs assessed risk of bias by using validated tools.
Data Synthesis: Of 32 included studies, 20 allowed for assessment of NSF risk after exposure to newer GBCAs and 12 (11 cohort studies and 1 case–control study) allowed for comparison of NSF risk between newer and older GBCAs. Among 83 291 patients exposed to newer GBCAs, no NSF cases developed (exact 95% CI, 0.0001 to 0.0258 case). Among the 12 studies (n = 118 844) that allowed risk comparison between newer and older GBCAs, 37 NSF cases developed after exposure to older GBCAs (exact CI, 0.0001 to 0.0523 case) and 4 occurred (3 confounded) after exposure to newer GBCAs (exact CI, 0.0018 to 0.0204 case). Data were scant for patients with acute kidney injury or those at risk for chronic kidney disease.
Limitations:
Study heterogeneity prevented meta-analysis. Risk of bias was high in most studies because of inadequate exposure and outcome ascertainment.
Conclusion:
Although NSF occurrence after exposure to newer GBCAs is very rare, the relatively scarce data among patients with acute kidney injury and those with risk factors for chronic kidney disease limit conclusions about safety in these populations.