Iodixanol and ioxaglate in adult aortography and peripheral arteriography: a phase III clinical trial.

Abstract

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.

• Authors: J D Rosenblum, E L Siegel, J Leef, D A Eckard, C T Lu
• Journal: Academic radiology (Acad Radiol) Vol. 3 Suppl 3 Pg. S514-8 (Sep 1996) ISSN: 1076-6332 [Print] United States
• PMID: 8883530 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Contrast Media
• Triiodobenzoic Acids
• iodixanol
• Ioxaglic Acid

Topics

• Adult
• Aged
• Aged, 80 and over
• Angiography
• Aortography
• Contrast Media (adverse effects)
• Double-Blind Method
• Extremities (blood supply)
• Female
• Humans
• Ioxaglic Acid (adverse effects)
• Male
• Middle Aged
• Triiodobenzoic Acids (adverse effects)