Bracco Diagnostics Issues Clarification on Study of Nephrotoxic Effects Associated With Angiography.

Business Editors/Health/Medical Writers

PRINCETON, N.J.--(BUSINESS WIRE)--March 14, 2003

In response to a study recently reported in the New England Journal of Medicine that demonstrated some significant differences in renal tolerability between iodixanol (Visipaque(R)) and iohexol (Omnipaque(R)), Bracco Diagnostics Inc. has issued a letter to cardiologists and radiologists throughout the United States clarifying that its product iopamidol (Isovue(R)) was not included in this study and that any conclusion from the results of this study cannot (and should not) be extended to other products that were not investigated in the trial.

This European study, Nephrotoxic Effects in High-Risk Patients Undergoing Angiography (NEPHRIC) (N Engl J Med 2003; 348: 491-499), suggests a clinical advantage of Visipaque over Omnipaque in that Visipaque reduces the risk of developing contrast nephropathy compared to Omnipaque in patients with diabetes mellitus undergoing angiographic procedures.

An accompanying editorial written by Carl Sanders, MD, University of Texas, Houston Medical School, concluded:

"...since previous clinical studies have yielded conflicting results, there is reason to believe that future studies of iodixanol may provide conflicting data as well." (New Engl J Med 2003; 348: 551-553).

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 Diagnostics Inc. concurs with Dr. Sandler's conclusion that future studies might provide evidence conflicting with the results of the NEPHRIC study. Specifically, we believe that ongoing clinical investigations will show no clinical benefit of Visipaque over Isovue in diabetic patients undergoing diagnostic or interventional angiographic procedures. In addition, we are in full support of even further investigations in this regard," said Alberto Spinazzi, MD, Senior Vice President, Group Medical Affairs, for Bracco Diagnostics Inc.