Phase III clinical trial comparing iodixanol and iohexol in cerebral angiography.

Rationale And Objectives: We report on our early clinical experience in the United States with the nonionic dimeric (6:1 ratio) contrast medium iodixanol in cerebral angiography. Iodixanol has an osmolality less than half that of monomeric, nonionic contrast media such as iohexol at equivalent iodine concentrations and is isosmotic to blood.

Methods: Forty-nine adult patients undergoing elective cerebral angiography were studied in a phase III, double-blind, randomized, parallel-design clinical trial comparing the safety and diagnostic efficacy of iodixanol at 320 mg I/ml (IOD-320) and iohexol 300 mg I/ml (IOH-300). Diagnostically adequate cerebral angiograms were routinely obtained with both contrast agents.

Results: A total of 37% of the patients experienced adverse events (48% in the IOD-320 group and 25% in the IOH-300 group). No statistically significant differences were noted between the two groups studied in the proportion of patients with one or more adverse events or in the intensity of the adverse events. The most common adverse event was headache. There were no deaths or serious complications related to either contrast medium in this study.

Conclusion: The results of this phase III trial support the conclusion that iodixanol at a concentration of 320 mg I/ml is comparable to iohexol at 300 mg I/ml in terms of efficacy (overall radiographic diagnostic visualization) and safety.