Preliminary European intravenous clinical experience with a new, low osmolar, nonionic contrast medium: ioversol (Optiray).
The intravenous clinical trial program of ioversol (Optiray), a low osmolar, nonionic, monomeric contrast agent characterized by high hydrophilicity, is evaluated on the basis of results from the first clinical trials conducted in Europe as part of the development of the 300 and 350 mgI/ml formulations: 7 double-blind, comparative trials and 5 single trials were performed in a total of 743 patients, of whom 472 received ioversol and 271 a monomeric nonionic reference product. The diagnostic efficacy of ioversol was equivalent or superior to that of the reference products and tolerance was comparable to that of nonionic agents in terms of pain and heat sensations. No significant difference in adverse reactions was found and all the contrast agents studied were well tolerated by the patients.
Le Mignon
M M
MM
Research and Development Division Laboratoire Guerbet, Aulnay sous Bois, France.
Azau
C
C
Arthaud
A
A
Bonnemain
B
B
D000328:Adult; D015901:Angiography, Digital Subtraction; D003287:Contrast Media / Q000009:adverse effects; D004311:Double-Blind Method; D005060:Europe; D006801:Humans; D008875:Middle Aged; D010690:Phlebography; D014057:Tomography, X-Ray Computed; D014283:Triiodobenzoic Acids / Q000009:adverse effects; D014567:Urography
D003287:Contrast Media; D014283:Triiodobenzoic Acids; C054871:ioversol