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 The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. 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 nephrotoxic /neph·ro·tox·ic/ (nef´ro-tok?sik) destructive to kidney cells.
Toxic, or damaging, to the kidney. Effects in High-Risk Patients Undergoing Angiography angiography
X-ray examination of arteries and veins with a contrast medium to differentiate them from surrounding organs. The contrast medium is introduced through a catheter to show the blood vessels and the structures they supply, including (NEPHRIC nephric /neph·ric/ (nef´rik) renal.
Relating to or connected with a kidney.
pertaining to the kidney. ) (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 nephropathy /ne·phrop·a·thy/ (ne-frop´ah-the) disease of the kidneys.nephropath´ic
analgesic nephropathy compared to Omnipaque in patients with diabetes mellitus diabetes mellitus
Disorder of insufficient production of or reduced sensitivity to insulin. Insulin, synthesized in the islets of Langerhans (see Langerhans, islets of), is necessary to metabolize glucose. In diabetes, blood sugar levels increase (hyperglycemia). 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 radiographic (rā´dēōgraf´ik),
adj relating to the process of radiography, the finished product, or its use. 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.