Bracco issues Isovue clarification

Contrast agent developer Bracco Diagnostics of Princeton, NJ, has released a letter to U.S. cardiologists and radiologists stating that its Isovue product was not included in a recent New England Journal of Medicine study (February 2003, Vol. 348:6, pp. 491-499). The Nephrotoxic Effects in High-Risk Patients Undergoing Angiography (NEPHRIC) study concluded the risk of contrast-induced nephropathy could be reduced by the use of an iso-osmolar agent during angiography.

The study compared an iso-osmolar agent to a low-osmolar product, both manufactured by Amersham Health of Little Chalfont, U.K. The study found that using Amersham’s iso-osmolar agent, iodixanol (Visipaque), produced fewer contrast-related adverse events during angiography compared to Amersham’s low-osmolar product, iohexol (Omnipaque).

Amersham touted Visipaque’s safety profile at last week’s European Congress of Radiology in Vienna. But in the letter issued on March 14, Bracco took pains to point out that the NEJM study was a comparison of Amersham agents, and did not include Bracco’s low-osmolar product, iopamidol (Isovue), in the comparison.

"It should be clear that while the NEPHRIC study showed some clinical advantage of Visipaque over Omnipaque in diabetic patients undergoing angiography, the findings do not support that Visipaque offers a better renal safety profile than Isovue or other nonionic contrast media, in angiography or any other contrast-enhanced radiographic procedure. No previous clinical studies have shown significant differences in renal tolerability between Visipaque and Isovue," Bracco said.

By AuntMinnie.com staff writers
March 17, 2003

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Iso-osmolar contrast agent less likely to be nephrotoxic in high-risk patients, February 6, 2003

Acetylcysteine helps prevent nephrotoxicity during coronary angiography, February 6, 2003

Bracco set to reintroduce Kinevac, December 6, 2002

Bracco gets approvable letter for MultiHance, November 25, 2002

Mobile PET, Bracco team up, October 10, 2002

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