Iodixanol in leg phlebography: a randomized, double-blind parallel group phase III trial comparing iodixanol to ioxaglate.
OBJECTIVE
To evaluate the safety and efficacy of iodixanol (Visipaque) in phlebography in order to obtain experience from the use of this contrast medium in this i.v. indication.


METHODS
Phlebography was performed in 150 patients, as a comparative prospective, double-blind, randomized parallel group study comparing iodixanol 270 mgI/ml with ioxaglate 320 mgI/ml. The tolerability was assessed from occurrence of discomfort, adverse events up to 30 min following injection and late adverse events. Efficacy was assessed by recording the diagnostic information on each venous segment. Statistical analysis was performed using the Cochran-Mantel-Haenszel test in order to correct for a possible centre effect.


RESULTS
Frequency of patients reporting discomfort (P=0.002) or adverse events (P<0.001) was statistically significantly lower after the injection of iodixanol than after ioxaglate. There was no statistical difference regarding late adverse events and diagnostic information.


CONCLUSIONS
Iodixanol 270 mgI/ml yielded the same diagnostic information as ioxaglate 320 mgI/ml and was associated with fewer patients reporting adverse events and discomfort.
Sapoval
M R
MR
Department of Cardiovascular Radiology, Institut National de la Statisque et de la Recherche Medicale, Paris, France.
Beyssen
B M
BM
Girardot
C
C
Musset
M A
MA
Legmann
P
P
Brekke
O
O
Gaux
J C
JC
D000328:Adult; D000368:Aged; D003287:Contrast Media; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007485:Ioxaglic Acid / Q000009:adverse effects; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D010690:Phlebography / Q000009:adverse effects / Q000379:methods*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D014283:Triiodobenzoic Acids / Q000009:adverse effects
D003287:Contrast Media; D014283:Triiodobenzoic Acids; C044834:iodixanol; D007485:Ioxaglic Acid