EVALUATION OF IOPENTOL (IMAGOPAQUE(R)-350) IN CT ENHANCEMENT - A MULTICENTER MONITORING TRIAL ASSESSING ADVERSE EVENTS AND DIAGNOSTIC INFORMATION - RESULTS FROM 1,823 PATIENTS IN FRANCE

Objectives: To evaluate the safety and efficacy of iopentol 350 mg I/m l (Imagopaque(R)/Ivepaque(R), Nycomed Imaging AS, Oslo, Norway), a mon omeric non-ionic contrast medium for computed tomography, in a large p opulation. To identify predictive factors for patient safety. Material s and methods: One thousand eight hundred and twenty-three (1,823) pat ients from 48 centres in France were included during a 5-month period. Safety was evaluated by registering adverse events (AEs) reported by the patients, and data were analysed using a multiple factor model. Re sults: Only 2.6% of the patients experienced AEs other than discomfort . There were no serious AEs. Overall, AEs were more frequent in patien ts under 50 years of age, in women, and in patients who received contr ast medium as a single bolus. Contrast enhancement was considered adeq uate or better in 98.9% of the patients. A large variation in discomfo rt (local warmth/chill or pain) frequency was seen between centres, ra nging from 0% to 81%. This result implies that factors other than the CM influence the incidence of discomfort. Conclusions: This first stud y in a large population shows that iopentol 350 mg I/ml is well tolera ted and provides CT images of excellent, good or adequate quality in t he vast majority of patients. Age, sex and injection procedure were sh own to be independent predictors in the AE survey.