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

Acad Radiol. 1996 Sep:3 Suppl 3:S514-8. doi: 10.1016/s1076-6332(05)80368-x.

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • 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

Substances

  • Contrast Media
  • Triiodobenzoic Acids
  • iodixanol
  • Ioxaglic Acid