A DOUBLE-BLIND-STUDY COMPARING SAFETY, TOLERABILITY AND EFFICACY OF IODIXANOL 320 MGI ML AND IOXAGLATE 320 MGI/ML IN CEREBRAL ARTERIOGRAPHY/

Iodixanol is a new nonionic dimer, isotonic with blood at all concentr ations. Iodixanol 320 mgI/ml was compared in a double-blind, randomize d study to the ionic dimer ioxaglate 320 mgI/ml for evaluation of safe ty and efficacy parameters during cerebral arteriography. Eighty adult patients were enrolled and all completed the trial. Radiographic effi cacy was assessed from the diagnostic information and the radiographic density. Safety was evaluated by recording discomfort and other adver se events, changes in ECG, heart rate and blood pressure, changes in i ntra-arterial blood pressure and circulation time. No difference betwe en the two contrast media were noted radiographically. No clinically i mportant changes from baseline or between the two contrast media were found in ECG, heart rate, blood pressure or intra-arterial blood press ure. Although not statistically significant, a somewhat longer mean ci rculation time was found with iodixanol, probably due to its slightly higher viscosity. Injection-associated warmth sensation and pain were more intense with ioxaglate than with iodixanol, and pain was statisti cally more frequent after injection of ioxaglate. A high incidence of adverse events other than discomfort is reported in this study, mainly related to the selective arteriographic procedure itself. The adverse events related to the contrast medium were more frequent with ioxagla te (27% of the total number of adverse events) than with iodixanol (10 %). The new isotonic nonionic dimer iodixanol offers significantly bet ter comfort to the patient than does ioxaglate. This is an important f eature, especially in relatively risky procedures that are unpleasant for the patients, such as conventional cerebral angiography.