A COMPARISON OF IOPROMIDE WITH IOPAMIDOL AND IOHEXOL FOR CONTRAST-ENHANCED COMPUTED-TOMOGRAPHY

RATIONALE AND ORJECTIVES. Iopromide is a new monomeric, nonionic contr ast agent that exhibits low osmolality and low viscosity in high conce ntration in aqueous solutions. Double-blind, randomized clinical trial s have established the efficacy, safety, and tolerance of iopromide fo r excretory urography, coronary angiography, routine and digital subtr action angiography, and phlebography. However, iopromide had not previ ously been evaluated in blinded clinical trials for contrast-enhanced computed tomography (CECT). Thus, a double-blind, prospective randomiz ed trial was performed to compare the efficacy, safety, adverse experi ence profile, and tolerance of iopromide to that of iopamidol and iohe xol in patients requiring CECT of the head or body. METHODS. Of 190 pa tients entered into the study, 95 received iopromide and 95 received a comparator (iopamidol, n = 55; and iohexol, n = 40) at 300 mg I/mL. E fficacy, adverse experiences (AEs), and tolerance were measured, and a safety profile was obtained that monitored changes at 24 hours in phy sical examination, vital signs, hematologic profile, and blood chemist ries. RESULTS. Efficacy was similar for all drugs with excellent/good visualization in 98.4% of studies. The total number of patients report ing AEs was equivalent (iopromide 13.8%, comparators 12.6%; P > .10). However, although 2.5% of patients in the iopromide and iopamidol grou ps had possibly related mild AEs, 15% receiving iohexol had related AE s, one of which was severe. Excellent tolerance was noted, with no pat ients reporting localized pain; there were low rates of mild to modera te 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, exc ept for a significantly increased incidence of systolic blood pressure decrease by greater than 20 mm Hg at 24 hours in the comparator group . CONCLUSIONS. Iopromide has an efficacy, safety, and tolerance profil e 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 io hexol, but is similar to iopamidol. Thus, iopromide is a reasonable ch oice of nonionic contrast medium for all CECT procedures.