Guerbet - Another Proof That There is no Difference Between Low-Osmolarity Contrast Agents and Iso-Osmolar Agent for Prevention of Contrast-Induced Nephropathy

Oct 27, 2006, 01:00 ET from Guerbet

    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,
     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 ( 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,

SOURCE Guerbet