Iodixanol and ioxaglate in adult aortography and peripheral arteriography: a phase III clinical trial.
RATIONALE AND OBJECTIVES: This study compared the safety and efficacy of iodixanol with those of ioxaglate in adult patients undergoing aortography or peripheral arteriography. METHODS: Forty-six patients were enrolled in this controlled, randomized, double-blind, two-center study. The patients were monitored for adverse events, injection-related discomfort, and trends in laboratory data or vital signs. Diagnostic efficacy was assessed by the quality of contrast enhancement. RESULTS: All procedures were diagnostic, with no significant difference in quality of visualization (p = .205). No significant difference was seen in the number of patients experiencing mild or moderate adverse effects (p = .106). Patients receiving ioxaglate reported a significantly greater incidence of injection-related pain (p = .025). CONCLUSION: The results of this study support the conclusion that iodixanol at 320 mg I/kg is safe and effective for adult aortography and peripheral arteriography and causes significantly less injection-related pain than ioxaglate.[1]References
- Iodixanol and ioxaglate in adult aortography and peripheral arteriography: a phase III clinical trial. Rosenblum, J.D., Siegel, E.L., Leef, J., Eckard, D.A., Lu, C.T. Academic radiology. (1996) [Pubmed]
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