GE Healthcare today announced results from a new study, which showed that patients receiving Visipaque(tm) (iodixanol) 320mg I/ml reported less discomfort, characterized by heat or cold sensation or pain upon injection, than patients receiving Isovue(r) (iopamidol) 370 mg I/ml during peripheral arteriography. As with other iodinated contrast agents, Visipaque is often associated with sensations of discomfort, warmth or pain. The data were presented at the American College of Cardiology's 63rd Annual Scientific Session and Expo.[i]

"Contrast-induced discomfort is commonly seen in patients undergoing peripheral arteriography," said Thomas Todoran, M.D., lead author of the study and Assistant Professor of Medicine, Director of Vascular Medicine at Medical University of South Carolina. "Patient discomfort continues to be a challenge, primarily because of potential for body movement that may lead to image degradation. Results from this study showed that Visipaque use led to significantly less patient discomfort, heat or pain when compared to Isovue. The results of this comparative study suggest that Visipaque may be a preferable contrast agent for use in peripheral arteriography."

While this study was not powered to detect a difference in image quality, the number of subjects with image quality rated as excellent was numerically greater in the Visipaque group (86.5%) versus the Isovue group (82.4%), but the difference was not statistically significant. Discomfort impacted image quality in 6.5% of Isovue subject images and in 3.2% of Visipaque subject images.

About the Study
This prospective, multicenter, randomized, double-blind, parallel group, comparative study evaluated and compared contrast-induced patient discomfort, overall safety and image quality following contrast administration in 253 patients receiving either Visipaque 320mg I/mL or Isovue 370mg I/mL, The study conducted at 13 sites throughout  Europe and the United States. Of these, 249 patients (125 Visipaque, 124 Isovue) completed discomfort assessments. Contrast-induced discomfort, specifically coldness, heat or pain, was assessed within 10 minutes following each contrast injection and rated verbally by the patient on a 0-to-10 scale.

The study found administration of Visipaque 320 mg I/mL resulted in less frequent and less severe patient reports of discomfort than did iopamidol 370 mg I/mL, during overall injection, with heat and pain being the major contributors. Specifically:

*      Significantly fewer patients receiving Visipaque reported severe discomfort (16.9% vs. 46.4%, p<0.0001), heat (15.3% vs. 36.8%; p<0.0002), and pain (2.4% vs. 23.2%, p<0.0001) than did patients receiving Isovue.

*       No difference was observed for other safety parameters between the two groups.

*       No significant differences were seen in image quality between the two groups.

"This study is significant and further proof of our commitment to our continued research in contrast media to improve patient care," said Jan Makela, General Manager, Core Imaging, GE Healthcare Life Sciences. "The study results provide relevant information to interventional cardiologists on patient discomfort following administration of different contrast agents, which may help them in their choice of appropriate contrast media."

Serious, life-threatening and fatal reactions, mostly of cardiovascular origin, have been associated with the administration of iodine-containing contrast media, including Visipaque. Most deaths occur during injection or five to ten minutes later. Rare reports of anaphylaxis have been documented during postmarketing surveillance. As with other contrast agents, Visipaque is often associated with sensations of discomfort, warmth or pain. The reported incidence of adverse reactions to contrast media in patients with a history of allergy is twice that of the general population. Patients with a history of a previous reaction to a contrast agent are three times more susceptible than other patients.