Iodixanol in cerebral computed tomography: a randomized, double-blind, phase III, parallel study with iodixanol an iohexol

Iodixanol is a new nonionic dimer, isotonic with blood at all clinically re levant concentrations. Iodixanol (270 mg I/ml) was compared in a double-bli nd, randomized, parallel-group, phase-III study to the monomeric nonionic i ohexol (300 mg I/ml) for evaluation of safety, tolerability and radiographi c efficiency during cerebral CT. One hundred adult patients scheduled to un dergo contrast-enhanced cerebral CT were randomly allocated to receive eith er iodixanol or iohexol, All completed the trial. Safety was evaluated by r ecording discomfort and other adverse events, tolerance by assessing intens ity and incidence of discomfort. Radiographic efficacy was assessed from th e diagnostic information and the radiographic density. No serious adverse e vents occurred. One patient (2%) in the iodixanol group and one patient (2% ) in the iohexol group experienced a transient reddening at the neck and lo wer neck-line, respectively. Both contrast agents were well tolerated. One patient (2%) int eh iodixanol group and two patients (4%) in the iohexol gr oup experienced a sensation of warmth (discomfort) in connection with the i njection. No difference between the two contrast media were noted radiograp hically. This comparison between iodixanol and iohexol showed both contrast media to be safe, well-tolerated and efficacious for use in cerebral CT.