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Guerbet (GBT) - Another Proof That There Is No Difference Between Low-Osmolarity Contrast Agents And Iso-Osmolar Agent For Prevention Of Contrast-Induced Nephropathy


10/27/2006 2:38:29 PM

WASHINGTON, October 27 /PRNewswire/ -- Results from a recent clinical trial demonstrated that contrast agents Hexabrix(R) (Ioxaglate) and Visipaque(R) (Iodixanol) were no different in regard to nephrotoxicity in patients with chronic renal failure undergoing interventional procedures. Results from this clinical trial were presented at the Transcatheter Cardiovascular Therapeutics 18th Annual Scientific Symposium in Washington, D.C.

Principal Investigator Roxana Mehran, MD, of Columbia University (NY), who presented the results of the ICON clinical study [Ionic versus non-ionic Contrast to Obviate worsening Nephropathy after angioplasty in chronic renal failure patients] concluded that "There was no difference between the 2 products at any time with regards to the incidence of contrast induced nephropathy. In patients with chronic renal insufficiency, preventative measures, such as proper hydration and contrast volume optimization, remain key in reducing the risk."

The clinical study was a multi-center, double-blind, randomized pilot study designed to compare Ioxaglate, an ionic low-osmolar contrast media manufactured by Guerbet, and Iodixanol, a nonionic contrast agent. The study included 145 patients with stable chronic renal disease, particularly susceptible to developing a contrast induced nephropathy, with high rates of diabetes (46 %), hypertension (82 %) and congestive heart failure (26 %). They were randomized to receive either Ioxaglate (74 patients) or Iodixanol (71 patients) during their procedures. The two groups had similar baseline demographics, received similar contrast agent doses and were treated with similar procedures and adjunctive medications. Before and after contrast administration, all subjects were well hydrated with 0.45 normal saline and received approximately 3.7L of fluid.

The diagnosis of nephropathy induced by the injection of contrast agents is based on a creatinine increase of 0.5 mg/dL or by 25 % from baseline. The study's primary endpoint was the mean peak increase in creatinine between the administration of the contrast agent and the 3rd day following administration. The results showed that there was no statistically significant differences between the two treatment groups in regard to the increase in serum creatinine after coronary catheterization. These results confirm numerous other recent studies and meta-analyses which have shown no difference among various contrast media agents.

This study also supports the conclusion that the keys to managing the incidence of contrast-induced nephropathy include proper identification of at-risk patients, adequate hydration pre- and post-administration of the contrast medium, and optimization of the amount of contrast media administered to the patient.

About Hexabrix(R) (ioxaglate)

Hexabrix(R) is a low osmolality iodinated contrast agent whose unique anticoagulant and anti-platelet properties make it particularly suitable for interventional cardiology[1]. The benefits it brings during interventional surgical procedures were confirmed by a study in more than 500 patients[2] and published in 2006. Hexabrix(R), a registered trademark of Guerbet, has a broad range of indications in adults and children and is licensed in more than 60 countries[3].

About Guerbet

Guerbet (www.guerbet.com) is the only pharmaceutical group fully dedicated to medical imaging. It has the most comprehensive range of x-ray and MRI contrast media available worldwide. These products assist medical professionals (radiologists, cardiologists, oncologists, etc.) in better diagnosing and treating their patients (cardiovascular, cancer, inflammatory and degenerative diseases).

To develop new products and assure its future growth every year, Guerbet devotes significant resources to research and development: 160 R&D employees and approximately 10% of sales.

Guerbet is solidly positioned in Europe with a growing market share of already 25% and is expanding its presence in the United States and Japan.

[1] AL DIERI et al. 2003, HEPTINSTALL et al. 1998

[2] LE FEUVRE C. et al - Cathet Cardiovasc Interv 2006

[3] Please refer to the local Summary of product specifications for further details.

Media Contact : Mai Tran - Ruder Finn +33-(0)1-56-81-15-03, mtran@ruderfinn.fr

Guerbet

CONTACT: Media Contact : Mai Tran - Ruder Finn +33-(0)1-56-81-15-03,mtran@ruderfinn.fr


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