A RANDOMIZED, DOUBLE-BLIND TRIAL OF IOMEPROL AND IOPROMIDE IN INTRAVENOUS EXCRETORY UROGRAPHY

The aim of this double-blind, parallel group study was to compare the safety, tolerance and diagnostic efficacy of iomeprol 350 mgI/ml and i opromide 370 mgI/ml in 100 adult patients undergoing intravenous excre tory urography. Fifty patients were randomised to receive 50 ml iomepr ol 350 mgI/ml and 50 to receive 50 mi iopromide 370 mgI/ml. Intravenou s administration of the contrast agents was always completed in 30 sec onds. Images were obtained immediately after and 5, 10 and 15 min afte r completion of contrast medium injection. Nephrogram and pyelogram op acification quality was blindly graded according to a four point scale as follows: 0, nondiagnostic; 1, diagnostic but of limited quality; 2 , diagnostic and of good quality; 3, fully diagnostic and of very good quality'. At the end of each individual patient study, the overall di agnostic quality of the procedure was reported as the sum of the score s attributed to each quality of nephrogram and pyelogram opacification quality on different images (0-4, nondiagnostic procedure; 4-8, diagn ostic procedure; 9-12, excellent or good procedure). The tolerability of the test compounds was evaluated in terms of discomfort (heat and p ain) associated with the injection of the test compounds. All patients were continuously monitored for adverse experiences for;l h after com pletion of the urographic procedure. Reporting of untoward reactions w as both spontaneous and elicited. The quality bf the radiographs was j udged as excellent or good in most cases, without significant differen ces between the two study groups. The distribution of scores of overal l diagnostic quality of procedures was similar for the two groups. Hea t sensation during contrast injection was reported significantly more frequently by patients receiving iopromide (P = 0.046). Adverse events were also more frequently observed in the iopromide group (14 in the iomeprol group and 21 in the iopromide group). All adverse events were transitory and non-serious, and most of them were reported as mild in intensity. Iomeprol 350 mgI/ml is at least as safe and effective as i opromide 370 mgI/ml when used for intravenous excretory urography.