IODIXANOL AND IOXAGLATE IN CARDIOANGIOGRAPHY - A DOUBLE-BLIND RANDOMIZED PHASE-III STUDY

A new non-ionic, dimeric contrast medium iodixanol (Nycomed AS, Norway ) has a very low osmolality and is isotonic with blood. It has been co mpared with ioxaglate (Hexabrix(R), Laboratoire Guerbet, France) in a double-blind, randomized, parallel trial. The aims of the trial were t o evaluate and compare the safety (vital signs, adverse events, discom fort and clinical-chemical parameters in blood and urine) and radiogra phic efficacy (diagnostic information and radiographic density) of iod ixanol 320 mg I/ml vs ioxaglate (Hexabrix 320 mg I/ml) in coronary ang iography and left ventriculography. Seventy-six patients referred for cardioangiography, two patients were withdrawn, 36 receiving iodixanol and 38 ioxaglate were included in the trial. Six patients (16%) in th e iodixanol group and 16 (42%) patients in the ioxaglate group reporte d adverse events (P = 0.02). One serious adverse event occurred in the iodixanol group where a patient experienced transient cortical blindn ess and transitory global amnesia, but the patient recovered completel y the day after the examination. Twenty-six patients reported injectio n-associated sensation of warmth in the iodixanol group versus 34 in t he ioxaglate group (P = 0.06). Following contrast injection there were no differences between the groups regarding vital signs (ECG, heart r ate, left ventricular pressures). Both contrast media were well tolera ted by the kidneys, and on average only minor effects on clinical-chem ical parameters in blood and urine were observed in the two groups. Th e radiographic efficacy was good in both groups.