Comparative investigation of i.v. iohexol and iopamidol: effect on renal function
in low-risk outpatients undergoing CT.
Author(s): Dillman JR, al-Hawary M, Ellis JH, Cohan RH, Kaza R, Myles JD, Khalatbari S,
Francis IR.
Affiliation(s): Department of Radiology, University of Michigan Health System, 1500 E Medical
Center Dr, Ann Arbor, MI 48109-5252, USA. jonadill@med.umich.edu
Publication date & source: 2012, AJR Am J Roentgenol. , 198(2):392-7
OBJECTIVE: The purpose of our study was to compare the effects of i.v. iohexol
and iopamidol on renal function in outpatients undergoing CT.
SUBJECTS AND METHODS: We performed a prospective, double-blind, randomized
clinical trial of 389 adults with low risk for contrast-induced nephropathy,
comparing i.v. iohexol with iopamidol (300 mg I/mL). Serum creatinine (SCr)
concentration was measured at baseline and 2 and 3 days after contrast
administration. A noninferiority analysis was planned to compare the mean maximum
SCr change from baseline between subject groups. Contrast-induced nephropathy
rates (three definitions) for both contrast agents were compared as a secondary
end point.
RESULTS: One hundred ninety and 199 subjects received iohexol and iopamidol,
respectively. The mean change in SCr from baseline using the maximum day 2 or 3
measurement was 0.07 ± 0.12 mg/dL (95% CI, 0.05-0.09 mg/dL) for the iohexol group
and 0.05 ± 0.12 mg/dL (95% CI, 0.03-0.07 mg/dL) for the iopamidol group. The
difference between contrast agents with respect to the mean change in SCr from
baseline was -0.02 ± 0.12 mg/dL (95% CI, -0.045 to 0.003 mg/dL; p = 0.08).
Contrast-induced nephropathy rates were not statistically different using any
definition.
CONCLUSION: Although our results were unable to show absolute noninferiority of
iohexol compared with iopamidol because of a very small difference in increase in
mean SCr from baseline (using a noninferiority margin of 0.04 mg/dL), this
difference is likely of minimal or no clinical importance in outpatients
undergoing CT with low risk for contrast-induced nephropathy.
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