Ioversol in intravenous excretory urography. Evaluation of radiographic quality, patient tolerance and safety in four clinical studies.
Three randomized, parallel group, double-blind clinical trials (Study A, B and C) and one open-label, noncomparative clinical trial (Study D) were performed in adult patients to evaluate the radiographic quality, patient tolerance and safety of Optiray 300 (ioversol) in intravenous excretory urography. Comparative agents were iohexol (Study A and C) and iopamidol (Study B). Regarding the radiographic quality ioversol provided a statistically significant better ureter opacification (p = 0.029) compared to iohexol (Study A). In comparison to iopamidol (Study B) the mean degree of certainly with respect to the investigator's urogram-based diagnoses was statistically significant higher (p = 0.025) for ioversol. In these two studies the enhancement quality of regions visualized was higher in the ioversol groups than in the control groups. Regions investigated were: parenchyma, calyces, pelvis, ureters and the bladder. Ioversol, iohexol and iopamidol were found to be statistically comparable with regard to safety and patient tolerance. The results of these studies demonstrate that ioversol is an effective, well tolerated and safe contrast agent for intravenous excretory urography.
Jahn
H
H
Scientific Department, Mallinckrodt Medical GmbH, Hennef, Germany.
Müller-Späth
R
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006979:Hyperthermia, Induced; D007275:Injections, Intravenous; D007472:Iohexol / Q000008:administration & dosage / Q000009:adverse effects; D007479:Iopamidol / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D014283:Triiodobenzoic Acids / Q000008:administration & dosage / Q000009:adverse effects; D014567:Urography / Q000379:methods*
D003287:Contrast Media; D014283:Triiodobenzoic Acids; D007472:Iohexol; D007479:Iopamidol; C054871:ioversol