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  • Title: Comparison of iodixanol and ioxaglate for adult aortography and renal/visceral angiography: a phase III clinical trial.
    Author: Siegel EL, Rosenblum JD, Eckard DA, Leef J, Bergh J, Parsa MB, Redick ML.
    Journal: Acad Radiol; 1996 Sep; 3 Suppl 3():S507-13. PubMed ID: 8883529.
    Abstract:
    RATIONALE AND OBJECTIVES: 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. METHODS: 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. RESULTS: 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). CONCLUSION: Iodixanol resulted in improved safety and patient tolerability while providing images of equivalent diagnostic efficacy compared with ioxaglate.
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