Comparison of iodixanol and ioxaglate for adult aortography and renal/visceral angiography: A phase III clinical trial

Abstract

We investigated whether iodixanol offers improved safety or tolerance compared with ioxaglate and evaluated whether iodixanol-enhanced radiographs are diagnostically comparable or superior to those produced with ioxaglate. Iodixanol is a new isosmotic hexa-iodinated nonionic contrast agent being evaluated for intravascular use. Fifty-four adult patients undergoing renal or visceral angiography, aortography, or both were enrolled in a prospective, randomized, double-blind, two-center study in which iodixanol and ioxaglate were compared. Subjects were monitored for adverse events, injection-associated discomfort, and changes in laboratory parameters and vital signs. Efficacy was measured by the overall quality of angiographic enhancement. No serious adverse events occurred during this trial. Mild-to-moderate adverse events were more common in patients receiving ioxaglate (p = .041). Injection-associated pain was reported by three patients receiving ioxaglate and none receiving iodixanol (p = .093). Clinical laboratory and vital-sign data showed no differences between groups, and there was no difference in the overall quality of angiographic visualization (p = .711). Iodixanol resulted in improved safety and patient tolerability while providing images of equivalent diagnostic efficacy compared with ioxaglate.