A double-blind study of iopromide 300 for peripheral arteriography. Results of a multi-institutional comparison of iopromide with iohexol and iopamidol.

RATIONALE AND OBJECTIVES: The use of nonionic contrast media for peripheral angiography has been well established in various reports. These agents provide the clinical benefit of decreased pain and heat sensations thought to be a function of osmolality, viscosity, and vasodilation. Iopromide is a new nonionic contrast medium that has been extensively studied for both intravenous (i.v.) and intraarterial indications. This study compares iopromide with similar concentrations of two other nonionic agents to evaluate their efficacy, tolerance, and adverse effects in peripheral angiography. METHODS: Two prospective, double-blind, randomized comparative clinical trials compared the safety profile, tolerance, and diagnostic quality of iopromide with two control drugs, iopamidol and iohexol. Eighty-one patients received iopromide, 19 received iohexol, and 40 received iopamidol. The trials evaluated potential changes in routine hematologic, biochemical, and renal function studies up to 72 hours after completion of the studies. Efficacy evaluation was performed by a physician who was blinded to the contrast used. Tolerance and adverse effects were determined by questionnaire, direct observation, and chart review. RESULTS: Demographic parameters were comparable among the three study sites. There was no difference in vessel visualization or diagnostic quality of the examination among the three agents. Minor adverse events occurred in all groups. Serious adverse events were, in almost all instances, thought to be secondary to factors other than the contrast media administered. CONCLUSIONS: This study confirms the safety and efficacy of iopromide (300 mg I/mL) for peripheral arteriography. Its safety and efficacy profiles are comparable with those of iopamidol and iohexol at similar concentrations and dosage.