Comparison of iodixanol and ioxaglate for adult aortography and renal/visceral angiography: a phase III clinical trial.
OBJECTIVE
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).


CONCLUSIONS
Iodixanol resulted in improved safety and patient tolerability while providing images of equivalent diagnostic efficacy compared with ioxaglate.
Siegel
E L
EL
Department of Diagnostic Radiology, University of Kansas Medical Center, Kansas City 66160-7234, USA.
Rosenblum
J D
JD
Eckard
D A
DA
Leef
J
J
Bergh
J
J
Parsa
M B
MB
Redick
M L
ML
D000792:Angiography; D001027:Aortography; D003287:Contrast Media / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007485:Ioxaglic Acid / Q000009:adverse effects; D007668:Kidney / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014283:Triiodobenzoic Acids / Q000009:adverse effects; D014781:Viscera / Q000098:blood supply*
D003287:Contrast Media; D014283:Triiodobenzoic Acids; C044834:iodixanol; D007485:Ioxaglic Acid