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. The benefits it brings during
interventional surgical procedures were confirmed by a study in more than
500 patients 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.
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.
 AL DIERI et al. 2003, HEPTINSTALL et al. 1998
 LE FEUVRE C. et al - Cathet Cardiovasc Interv 2006
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