IOPENTOL (IMAGOPAQUE(R)-350) COMPARED WITH DIATRIZOATE (UROGRAFIN(R)-370) IN CEREBRAL CT - A CLINICAL-TRIAL ASSESSING IMMEDIATE AND LATE (7DAYS) ADVERSE EVENTS AND DIAGNOSTIC INFORMATION (VISUALIZATION QUALITY AND HOUNSFIELD UNIT MEASUREMENTS)

The non-ionic contrast medium iopentol (Imagopaque(R), Nycomed Imaging AS, Oslo, Norway) 350 mg I/ml was compared for safety and efficacy wi th the ionic contrast medium diatrizoate (Urografin(R), Schering AG, B erlin, Germany) 370 mg I/ml in a randomized, double-blind, parallel-gr oup clinical trial in cerebral computed tomography (CT). The numbers o f participating patients was 79; forty in the iopentol group and 39 in the diatrizoate group. Safety I was evaluated by assessing the number s of patients reporting immediate adverse events (up to 30 min after i njection) and delayed adverse events (within 7 days after the examinat ion). Efficacy was expressed as the quality of visualization of the ce rebral lesions after injection of the contrast medium. In addition, Ho unsfield units were measured pre- and post-contrast. No patient in eit her group experienced any serious adverse event. The frequency of pati ents with immediate adverse events was statistically significantly low er in the iopentol group (23%) than in the diatrizoate group (64%), p= 0.0003. Delayed adverse events were also significantly less frequent i n the iopentol group (43%) than in the diatrizoate group (69%), p = 0. 047. Patients in the iopentol group reported significantly less discom fort (53%), especially sensation of warmth, than patients in the diatr izoate group (92%), p=0.0001. The intensity of adverse events and inje ction-associated discomfort seemed, in general, to be lower for patien ts in the iopentol group. No difference was found between the two cont rast media regarding efficacy.