Main results of the first comparative clinical studies on Visipaque.
The results are reviewed from 18 European clinical vascular studies in 1950 patients where iodixanol (Visipaque) - a new isotonic, dimeric, nonionic contrast medium (CM) - is compared to other CM. Visipaque gave better patient comfort, i.e., less pain and heat sensation after vascular injections than the comparative CM. Adverse events reported after Visipaque were otherwise similar to nonionic CM but lower than after ioxaglate (Hexabrix) and other ionic CM. Human renal safety of Visipaque has been extensively studied. Only small changes in glomerular filtration rate and serum creatinine were measured with the monomeric nonionic CM as well as with Visipaque. The excretion of marker enzymes for renal tubular cell function was generally lowest for Visipaque. Thus Visipaque was highly tolerable in the kidneys. To study cardiac safety, electrophysiological and hemodynamic changes were recorded. Visipaque had generally no electrophysiological or hemodynamic effects, or less pronounced effects compared to the other CM. Radiograms revealed that Visipaque 320 mg I/ml yielded the same attenuation as 350 to 370 mg I/ml of the other CM and, similarly, 270 mg I/ml of Visipaque gave as good visualization as 300 mg I/ml of comparative CM.
Grynne
B H
BH
Clinical Research & Development, Nycomed Imaging AS, Oslo, Norway.
Nossen
J O
JO
Bolstad
B
B
Borch
K W
KW
D002986:Clinical Trials as Topic; D003287:Contrast Media / Q000009:adverse effects*; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D007668:Kidney / Q000187:drug effects; D009420:Nervous System / Q000187:drug effects; D014283:Triiodobenzoic Acids / Q000009:adverse effects*
D003287:Contrast Media; D014283:Triiodobenzoic Acids; C044834:iodixanol