Corporate Report

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ICR 2006;2006:1(1):1-3

Since 1901, Guerbet has had a long-standing tradition as a pioneer in the research and development of contrast media for medical imaging. Headquartered in Paris, France, Guerbet is a publicly traded company, holding almost 22% of the European,1 and 8% of the worldwide market shares.

The product portfolio is marketed in 130 countries worldwide, and contains contrast agents for X-ray and magnetic resonance imaging (MRI) modalities - Oxilan®, Hexabrix®, Dotarem®, Lumirem®, Endorem® and other low osmolar products. Guerbet dedicates the best talent and resources to new drug research and development.

The US subsidiary, Guerbet LLC, was established in February2002, by purchasing the assets of Oxilan from Cook®. Currently, Guerbet LLC is responsible for the marketing, sales and distribution of Oxilan (ioxilan) Injection, a non-ionic contrast media for diagnostic and interventional imaging. Steps are under way to launch new products in the US market in the near future.

Oxilan - A Product by Guerbet

Since their arrival in the 1950s, contrast media (CM) has revolutionised diagnostic imaging. As these drugs continue to evolve, they have become safer for patients and easier for physicians to administer. Oxilan is a nonionic contrast-agent available from Guerbet. Oxilan is indicated intravenouly for contrast-enhanced computer tomography (CT) head and body imaging, and excretory urography. It is indicated intra-arterially for cerebral arteriography, coronary arteriography/left ventriculography, aortography, selective visceral angiography and peripheral arteriography.

The monomeric molecular structure of Oxilan provides both patient comfort and the visibility you need. The particularity of the Oxilan structure is to have a hydrophobic region masking with a hydrophilic group.3 This hydrophilic group increases solubility, which can contribute to rapid renal clearance3 and reduces binding with other molecular structures which may promote endothelial tolerance.3 Moreover, the hydrophobic region promotes 'transient molecular aggregation' of the molecules, reducing osmolality3 and achieving a lower osmolality at a diagnostically useful concentration.3

Lowest Osmolality of all Monomers

Osmolality is determined by the number of particles in a solution. Oxilan has the lowest osmolality of all nonionic monomers.1 Low osmolality improves patient comfort and minimises patient movement. In a randomised, parallel, double-blind controlled study of 112 patients, Oxilan was well tolerated on patient measures of pain and warmth.4 The threshold of vascular pain has been determined to be approximately 700-750 mOsms.5*

Low Viscosity Monomer

Viscosity is determined by the size of molecules in a solution. Oxilan has the lowest viscosity of all nonionic monomers in the 350-370 concentration range.1 The low viscosity not only allows for easy injection through small diameter catheters,6 but also provides better flow through small blood vessels and capillaries,7 as well as during high speed injection.8

Oxilan® and Safety
Arrhythmia

Oxilan contains sodium (9mmol/L Na) with a citrate buffer. The addition of sodium to CM solutions has been shown to reduce the risk of ventricular fibrillation (VF) in animal studies.9* Then, Oxilan produced a much lower incidence of VF compared to other nonionic monomers studied such as ioversol,9 iomeprol,9 iopromide,9 iohexol10).

Hemodynamics

In hemodynamic studies versus iohexol, Oxilan significantly decreased platelet aggregation and activation11 (clinical study, N=37) had less effect on the endothelium12* (animal study), had minimal effect on mean blood pressure and heart rate (animal study)13*, and had no negative inotropic effect (animal study).13*

Renal safety

Recent studies have shown that any low osmolar contrast media is as safe for contrast induced nephropathy as the iso osmolar.14 Furthermore, the Oxilan balance of low viscosity and low osmolality, may help reduce the risk of renal complications.15* Indeed, osmolality is not a factor in decreasing renal blood flow or glomerular filtration,16* high viscosity contrast media can both be responsible for hypoperfusion of the inner medulla, and cortex in animal studies16*, as well as significantly reducing renal blood flow from the baseline* and a low osmolar contrast media may have a greater potential for cytotoxic effects on proximal renal tubular cells, than monomeric contrast medias17* (in vitro study).

Indications

Oxilan is available in two concentrations for the following indications:

  • Intra-arterial - Oxilan (ioxilan) Injection (300mgI/mL) is indicated for cerebral angiography. Oxilan (ioxilan) Injection (350mgI/mL) is indicated for coronary arteriography and left ventriculography, visceral angiography, aortography and peripheral arteriography.
  • Intravenous - Oxilan (ioxilan) Injection (300mgI/mL) and (350mgI/mL) are indicated for excretory urography and contrast enhanced computed tomographic (CECT) imaging of the head and body.
References

*Clinical significance of this data is not known.

  1. Data on File. Guerbet LLC.
  2. Sold in the U.S. by Mallinckrodt under the license from Guerbet.
  3. Sovak M. The need for improved contrast media. Ioxilan: updating design theory. Investigative Radiology. 1988;23(1): S79-S83.
    Crossref | PubMed
  4. McIntosh, CL, et al. Ioxilan injection: an overview and results of aortofemoral arteriography study; Invest Radiol. 1994;29 Suppl 2:S40-42.
    Crossref | PubMed
  5. Sovak, M, et al. Current contrast media and ioxilan: comparative evaluation of vascular pain by aversion conditioning. Invest Radiol. 1988;23(1):S84-S87.
    Crossref | PubMed
  6. Roth, R, et al. Influence of radiographic contrast media viscosity to flow through coronary angiographic catheters. Cathet Cardiovasc Diag. 1991;22:290-294.
    Crossref | PubMed
  7. Dawson P, Clauss W. Contrast Media in Practice: Questions and Answers. 1999, Springer-Verlag Berlin Heidelberg.
    Crossref
  8. Eloy, R, et al. Contrast media for angiography: physiochemical properties, pharmacokinetics and biocompatibility. Clin Mater. 1991;7:89-197.
    Crossref | PubMed
  9. Misumi, K, et al. The risk of contrast media-induced ventricular fibrillation is low in canine coronary arteriography with ioxilan. J Vet Med Sci. 2000;62:421-426.
    Crossref | PubMed
  10. Sakamoto H et al. The effect of Ioxilan, a new nonionic contrast medium, on the cardiovascular system. J Jap Coll Angiol. 1992; 32 (12): 1347-1353.
  11. Ogawa T, et al. Effects of nonionic contrast media on platelet aggregation. Pn Heart J. 2001;42:115-124.
    Crossref | PubMed
  12. Schneider, KM, et al. Functional and morphologic effects of ioxilan, iohexol and diatrizoate on endothelial cells. Invest Radiol. 1988;23 Suppl 1:S147-S149.
    Crossref | PubMed
  13. Nakamura, H, et al. Effects of ionic and nonionic contrast media on cardiohemodynamics and quality of radiographic image during canine angiography. J Vet Med Sci. 1994;56:91-96.
    Crossref | PubMed
  14. iCARE and ICON studies presented during TCT 2006.
  15. Persson PB, Hansell P, Liss P. Pathophisiology of contrast medium-induced nephropathy. Kidney International. 2005; 68: 14-22.
    Crossref | PubMed
  16. Lancelot E, Idee JM, Couturier V, et al. Influence of the viscosity of iodixanol on medullary and cortical blood flow in the rat kidney: a potential cause of nephrotoxicity. J Appl Toxicol. 1999; 19:341-346.
    Crossref | PubMed
  17. Heinrich MC, Kuhlmann MK, Grgic A, et al. Cytotoxic effects of ionic high-osmolar, nonionic monomeric, and nonionic iso-osmolar dimeric iodinated contrast media on renal tubular cell in vitro. Radiology. 2005; 235: 843-849.
    Crossref | PubMed