IODIXANOL IN LEG PHLEBOGRAPHY - A RANDOMIZED, DOUBLE-BLIND PARALLEL-GROUP PHASE-III TRIAL COMPARING IODIXANOL TO IOXAGLATE

Purpose: To evaluate the safety and efficacy of iodixanol (Visipaque(C )) in phlebography in order to obtain experience from the use of this contrast medium in this i.v. indication. Patients and Methods: Phlebog raphy was performed in 150 patients, as a comparative prospective, dou ble-blind, randomized parallel group study comparing iodixanol 270 mgI /ml with ioxaglate 320 mgI/ml, The tolerability was assessed from occu rrence of discomfort, adverse events up to 30 min following injection and late adverse events. Efficacy,vas assessed by recording the diagno stic information on each venous segment, Statistical analysis was perf ormed using the Cochran-Mantel-Haenszel test in order to correct for a possible centre effect. Results: Frequency of patients reporting disc omfort (P=0.002) or adverse events (P<0.001) was statistically signifi cantly lower after the injection of iodixanol than after ioxaglate. Th ere was no statistical difference regarding late adverse events and di agnostic information. Conclusion: Iodixanol 270 mgI/ml yielded the sam e diagnostic information as ioxaglate 320 mgI/ml and was associated wi th fewer patients reporting adverse events and discomfort.