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


CONCLUSIONS
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.
Rosenblum
J D
JD
Department of Radiology, University of Chicago Medical School, IL, USA.
Siegel
E L
EL
Leef
J
J
Eckard
D A
DA
Lu
C T
CT
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D001027:Aortography; D003287:Contrast Media / Q000009:adverse effects; D004311:Double-Blind Method; D005121:Extremities / Q000098:blood supply*; D005260:Female; D006801:Humans; D007485:Ioxaglic Acid / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D014283:Triiodobenzoic Acids / Q000009:adverse effects
D003287:Contrast Media; D014283:Triiodobenzoic Acids; C044834:iodixanol; D007485:Ioxaglic Acid