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GE Healthcare announces results from Visipaque study

GE Healthcare has announced results from a new study, which showed that patients receiving Visipaque (iodixanol 320mg I/ml) were less likely to experience discomfort, characterized by heat or cold sensation or pain upon injection, than patients receiving Isovue (iopamidol 370 mg I/ml).

As with other iodinated contrast agents, Visipaque is often associated with sensations of discomfort, heat or pain. The data were published online in Acta Radiologica.

This prospective, randomized, double-blind, and parallel group study evaluated and compared contrast-induced patient discomfort and overall safety following contrast administration in 299 patients receiving either Visipaque 320mg I/mL or Isovue 370mg I/mL at nine centers in the US and Europe.

In patients undergoing contrast-enhanced computed tomography (CECT) imaging of the abdomen/pelvis using IV administration as part of their routine medical care, the study found administration of iso-osmolar Visipaque 320 mg I/mL resulted in less frequent and less severe patient discomfort than did low-osmolar iopamidol 370 mg I/mL, with heat being the major contributor. Specifically:

– Patients receiving Visipaque experienced significantly less moderate/severe discomfort (35.1% vs. 67.3%; p<0.0001) or heat (29.8% vs. 63.9%; p<0.0001), and severe discomfort (2.6% vs. 16.3%; p<0.0004) or heat (2.6% vs. 15%; p=0.0008) than patients receiving Isovue.

– 21.2% of Visipaque patients had no discomfort from contrast administration whereas 7.5% of Isovue patients had no discomfort from contrast administration (p=0.0008).

The overall image quality was graded as excellent for 95.4% of patients in the Visipaque group and 89.9% of patients in the Isovue group, though the difference did not reach statistical significance (p= 0.0508).

Other than patient discomfort there was no statistical difference between the two agents in adverse events reported in this trial. Patients receiving iodixanol, but not iopamidol, reported skin reactions, but the difference was not statistically significant.