RATIONALE AND OBJECTIVES.
Iopromide is a new monomeric, nonionic contrast agent that exhibits low osmolality and low viscosity in high concentration in aqueous solutions. Doubleblind, randomized clinical trials have established the efficacy, safety, and tolerance of iopromide for excretory urography, coronary angiography, routine and digital subtraction angiography, and phlebography. However, iopromide had not previously been evaluated in blinded clinical trials for contrastenhanced computed tomography (CECT). Thus, a doubleblind, prospective randomized trial was performed to compare the efficacy, safety, adverse experience profile, and tolerance of iopromide to that of iopamidol and iohexol in patients requiring CECT of the head or body.
Of 190 patients entered into the study, 95 received iopromide and 95 received a comparator (iopamidol, n = 55; and iohexol, n = 40) at 300 mg I/mL. Efficacy, adverse experiences (AEs), and tolerance were measured, and a safety profile was obtained that monitored changes at 24 hours in physical examination, vital signs, hematologic profde, and blood chemistries.
Efficacy was similar for all drugs with excellent/ good visualization in 98.4% of studies. The total number of patients reporting AEs was equivalent (iopromide 13.8%, comparators 12.6%; P>.10). However, although 2.5% of patients in the iopromide and iopamidol groups had possibly related mild AEs, 15% receiving iohexol had related AEs, one of which was severe. Excellent tolerance was noted, with no patients reporting localized pain; there were low rates of mild to moderate warmth on injection (8.5% for iopromide versus 9.5% for comparators; P >.10).
Safety profiles were comparable. Postprocedure, there were no significant changes or significant differences between groups, except for a significantly increased incidence of systolic blood pressure decrease by greater than 20 mm Hg at 24 hours in the comparator group.
Iopromide has an efficacy, safety, and tolerance profile comparable to that of iopamidol and iohexol at 300 mg I/mL for head and body CECT. It may have a superior adverse experience profile to iohexol, but is similar to iopamidol. Thus, iopromide is a reasonable choice of nonionic contrast medium for all CECT procedures.