In the present trial kidney-specific proteins were studied enzymatically or quantitatively in patients' urine after intravascular administration of water-soluble X-ray contrast media, in order to judge about their renal tolerance. 5 clinical trials (phase III), including 198 patients, were carried through, within several radiological examinations. The examined X-ray substance was Iosimide, a new monomeric, nonionic low osmolar c.m. It was compared to the nonionic Iopromide and Iopamidol as well as to the ionic, high osmolar sodium-meglumine-diatrizoate. Enzyme activities of alanine-aminopeptidase (AAP), gamma-glutamyltransferase (GGT), beta-n-acetylglucosaminidase (NAG), kallikrein with creatinine as point of reference were kinetically measured in 4 urine samples (1 before c.m. administration the others as 24 hours urine samples of the following 3 days). Beside the quantitative determination of protein and albumin an electrophoresis was started, when diagnosis was obvious. Kallikrein was brought to the diagnostic palette of this study in order to include the distal segment of the nephron. The specific protein excretion patterns of nonionic c.m. in urine are not different from each other. In contradiction to this, the results of the low osmolar nonionic Iosimide compared to the high osmolar diatrizoate, show evident differences for the benefit of Iosimide.

01 Jul 1990·Arzneimittel-Forschung

Effect of three non-ionic contrast media on rats and rabbits with regard to renal changes. Interspecies comparison.

Article

Author: Schöbel, C ; Günzel, P ; Hofmeister, R ; Siegmund, F ; Bhargava, A S

The effect of three non-ionic contrast media (iosimide, iopamidol and iopromide) was investigated in rabbits and rats after single i.v. application up to high doses with regard to renal changes. Determinations of serum urea nitrogen and creatinine and urinary enzymes (lactate dehydrogenase, gamma-glutamyl-transpeptidase and N-acetyl-beta-D-glucosaminidase) as well as histological examinations of the kidneys were performed. The results obtained demonstrate that rabbit as an experimental animal was more sensitive than rat in exhibiting renal changes to contrast media. Furthermore, determinations of urinary enzymes demonstrated that gamma-GT in rabbits and LDH in rats were the most sensitive indicators for detection of early kidney damage. With regard to the high dose levels required, these kidney changes do not indicate any risk to humans at diagnostic dose levels.

01 Jan 1989·Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin. Erganzungsband

Pharmacokinetics of iohexol, iopamidol, iopromide, and iosimide compared with meglumine diatrizoate.

Article

Author: Taenzer, V ; Hartwig, P ; Mützel, W

Four nonionic contrast media (iohexol, iopamidol, iopromide, and iosimide) are compared in this clinical study in their pharmacokinetic behavior with an ionic reference preparation (meglumine diatrizoate). At a dose of 1 ml of contrast medium per kilogram of body weight with approximately the same iodine content, virtually no differences could be established in the pharmacokinetic behavior. The osmotic diuresis of the ionic substance, compared with that of the nonionic preparations--implies an increased osmotic diuresis, thus, a lower maximal iodine concentration in the urine. The elderly patients included in this study have a reduced glomerular filtration rate, which in turn implies a prolonged half-life in the blood and a retarded renal elimination.

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