Safety and efficacy of iopromide in cerebral arteriography.

ABSTRACT

RATIONALE AND OBJECTIVES: Iopromide is a new nonionic monomeric contrast medium for cerebral arteriography. This agent has been approved for sale in over 45 countries; however, it is still undergoing clinical review in the United States. This study evaluated the safety and efficacy of iopromide in comparison with two other nonionic contrast media. METHODS: A total of 173 patients participated in the study, which was prospective, double-blind, and randomized. In two centers, patients received iopromide or iohexol; in the other three centers, patients received iopromide or iopamidol. Adverse events were monitored by investigators, and efficacy was evaluated by grading the radiographic images. RESULTS: Most adverse events were mild or moderate in severity; all resolved completely. Twenty-one percent of patients given iopromide were reported to have a drug-related adverse event, versus 44% of patients given a comparator. No statistically significant difference emerged between iopromide and the comparators with regard to efficacy. CONCLUSIONS: These study results indicate that iopromide is a safe and effective contrast medium for cerebral angiography.