MAIN RESULTS OF THE FIRST COMPARATIVE CLINICAL-STUDIES ON VISIPAQUE -AN OVERVIEW OF 18 CLINICAL-STUDIES

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 gav e better patient comfort, i.e., less pain and heat sensation after vas cular injections than the comparative CM. Adverse events reported afte r Visipaque were otherwise similar to nonionic CM but lower than after ioxaglate (Hexabrix) and other ionic CM. Human renal safety of Visipa que has been extensively studied. Only small changes in glomerular fil tration rate and serum creatinine were measured with the monomeric non ionic CM as well as with Visipaque. The excretion of marker enzymes fo r renal tubular cell function was generally lowest for Visipaque. Thus Visipaque was highly tolerable in the kidneys. To study cardiac safet y, electrophysiological and hemodynamic changes were recorded. Visipaq ue had generally no electrophysiological or hemodynamic effects, or le ss pronounced effects compared to the other CM. Radiograms revealed th at 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.