IOHEXOL IN PATIENTS UNDERGOING UROGRAPHY - A COMPARISON OF POLYPROPYLENE CONTAINERS (UNIQUE-SOFT-PACK(R)) AND GLASS VIALS

The purpose of the present phase IV multicentre trial was to evaluate general patient tolerance to Omnipaque(R) 350 mgI/ml (iohexol) supplie d in polypropylene containers compared to that of the same product sup plied in routinely used glass vials, with emphasis on allergy-like adv erse events. Polypropylene is a pure plastic material with practically no additives, and has been tested in vitro as a contrast medium packa ging material for several years. Handling of these containers is easie r and safer than handling of glass vials. Iohexol was administered to 1481 patients undergoing urography (741 patients in the glass vial gro up, 740 in the polypropylene container group), all of whom successfull y participated in the trial. Six centres, representing four European c ountries, participated. Patients were randomized to receive iohexol fr om either polypropylene containers or traditional glass vials accordin g to a double blind, parallel design, Pre-established inclusion and pr e-admission exclusion criteria were followed, as web as routine proced ures for preparation of the patients and conduct of the urography exam inations at each hospital. Patient tolerance was assessed by recording all adverse events experienced over a period of up to 1 h after the p rocedure, Allergy-like events were defined as coughing, sneezing, naus ea, vomiting, urticaria or itching. No adverse events were experienced by 56.5% of the patients in the glass vial group, nor by 58.0% of tho se in the polypropylene group. Discomfort (mainly a sensation of warmt h) was reported by 39.4% and 38.6% of the patients, and ad,adverse eve nts other than discomfort by 7.4% and 5.9% of the patients, respective ly. There seemed to be a correlation between the speed of injection an d the frequency of discomfort (an increase with increasing speed), bot h of which varied a lot between centres. There was no significant diff erence in the incidence of allergy-like events between the two groups, Such reactions were seen in 2.0% of patients in the glass vial group and 1.9% of those in the polypropylene container group There was no si gnificant difference between the patients' tolerance to iohexol suppli ed in traditional glass vials or in polypropylene containers. Therefor e, the new polypropylene container can be recommended as a container f or Iohexol.