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Bracco Diagnostics Inc. Late-Breaking Clinical Trial Results Reveal No Statistically Significant Difference between Isovue(R)-370, or Visipaque(TM) 320 Injection in the Rate of CIN in High-Risk Patients Undergoing Computed Tomography


7/31/2008 6:44:18 AM

PRINCETON, N.J.--(BUSINESS WIRE)--The results of the Patients with REnal impairment and DIabetes undergoing Computed Tomography (PREDICT) study were just published in the American Journal of Roentgenology1 (Am J Roentgenol. 2008;191: 151-157). The PREDICT trial is the largest, prospective, randomized, double-blind comparison of the iso-osmolar iodixanol-320 with the low-osmolar iopamidol-370 in high-risk patients undergoing computed tomography (CT). The PREDICT study found no statistically significant difference between iopamidol-370 and iodixanol-320 in the rate of contrast-induced nephropathy (CIN) in high-risk patients undergoing CT.

The purpose of this multicenter, double-blind, randomized study was to prospectively compare the incidence of CIN following administration of the nonionic monomer iopamidol-370 (Isovue® -370, Bracco Diagnostics Inc., Princeton, NJ, 796 mOsm/kg) or the nonionic dimer iodixanol-320 (Visipaque™ 320, General Electric Healthcare, Princeton, NJ, 290 mOsm/kg) in 248 patients with moderate-to-severe chronic kidney disease and diabetes mellitus. CIN was defined as increases in serum creatinine equal or above 25% from baseline levels, detected at 48-72 hours following administration of the two contrast media.

“The PREDICT study shows that there is no statistically significant difference in the rate of CIN between the iso-osmolar iodixanol and the low-osmolar iopamidol in patients with significant renal impairment and diabetes, i.e., in those patients that are considered at high-risk for an acute and clinically important decline in renal function following the administration of intravascular contrast media. The PREDICT study reinforces the results of earlier published studies, the IMPACT Study2 and the CARE Study3, that also failed to find a difference between iodixanol and iopamidol when administered to at-risk patients,” said Matthew J. Kuhn, MD, Chief, Division of Neuroradiology, Clinical Professor, Department of Radiology, Neurology, and Neurosurgery Southern Illinois University School of Medicine, the lead investigator and expert in CIN.

“During the last five years there has been a great deal of discussion about CIN and the safety profile of various contrast media. It has been our goal to support research which could provide valid and reliable clinical evidence to the healthcare community on this very serious topic. PREDICT1 is the third head-to-head clinical trial comparing iopamidol and iodixanol which demonstrated no statistically significant differences between the two agents in at-risk patients. The first trial, IMPACT2, compared the agents following their intravenous injection in 153 patients with chronic kidney disease undergoing CT and the second trial, CARE3, the largest study, compared these agents following their intra-arterial injection in 414 high-risk patients who were undergoing cardiac angiography or percutaneous coronary intervention. Bracco Diagnostics Inc. is committed to investing in clinical research to advance the field of medical imaging,” stated Alberto Spinazzi, MD, Sr. VP, Group Medical and Regulatory Affairs at Bracco Diagnostics Inc.

While CIN remains a serious issue and patient safety is paramount, the PREDICT study found no statistically significant difference in the incidence of CIN between iopamidol and iodixanol when administered to high-risk patients undergoing CT examinations.

About Isovue

Isovue® (iopamidol injection) is a nonionic contrast medium with well established safety and efficacy, used in the United States since 1986. Worldwide, more than 250 million doses of iopamidol have been administered. Indicated for a wide variety of medical imaging procedures, Isovue offers desired flexibility by providing a wide range of iodine concentrations and packaging options. Isovue Multipack® Pharmacy Bulk package offers multi-dosing efficiency in 200 mL and 500 mL volumes. Isovue® Prefilled Syringes for use with the Medrad® injection systems provide efficient contrast media use and administration convenience. Isovue-370 is the highest concentration of contrast approved for CT in the United States. Isovue-M® is indicated for myelography and is another example of the Bracco commitment to support specialized imaging applications.

Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media. Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. As with all injectable contrast agents, the possibility of severe reactions should be borne in mind, regardless of the patient’s pre-existing medical history. As with any other iodinated contrast media, caution must be exercised in patients with severely impaired renal function, combined renal and hepatic disease, combined renal and cardiac disease, severe thyrotoxicosis, myelomatosis, or anuria, particularly when large doses are administered.

For more information and complete Prescribing Information, please go to http://www.bracco.com/usa/en-US/Imaging/XRay/Isovue/.

About Bracco Imaging

Bracco Imaging S.p.A. is one of the world’s leading companies in the diagnostic imaging business. Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions that meet medical needs and facilitate clinical solutions. Headquartered in Milan, Italy, Bracco Imaging operates in over 80 markets worldwide. Bracco Diagnostics Inc. is the U.S. subsidiary of Bracco Imaging.

Bracco Imaging is a subsidiary of Bracco S.p.A., the holding company of the Bracco Group which also markets Ethical and Over The Counter (OTC) pharmaceutical products in Italy as well as Advanced Medical Technology systems worldwide. Furthermore, the Bracco Group offers diagnosis services through the Milan-based Centro Diagnostico Italiano (Italian Diagnostic Center).

Visipaque is a trademark of GE Healthcare.

To access the actual study, click on the following URL or cut and paste it into your browser's address field: http://www.bracco.com/usa/en-US/Imaging/XRay/Isovue/.

IMPORTANT NOTICE: This press pack may include some products' commercial brands, which are not to be used unless by media addressed to the medical community.

1 Kuhn MJ, Chen N, Sahani DV, Reimer D, van Beek EJ, Heiken JP, So GJ. The PREDICT study: a randomized double-blind comparison of contrast-induced nephropathy after low- or isoosmolar contrast agent exposure. Am J Roentgenol. 2008 Jul;191(1):151-7

2 Barrett BJ, Katzberg RW, Thomsen HS, Chen N, Sahani D, Soulez G, Heiken JP, Lepanto L, Ni ZH, Ni ZH, Nelson R. Contrast-induced nephropathy in patients with chronic kidney disease undergoing computed tomography: a double-blind comparison of iodixanol and iopamidol. Invest Radiol 2006; 41: 815-821

3 Solomon RJ, Natarajan MK, Doucet S, Sharma SK, Staniloae CS, Katholi RE, Gelormini JL, Labinaz M, Moreyra AE; Investigators of the CARE Study. Cardiac Angiography in Renally Impaired Patients (CARE) study: a randomized double-blind trial of contrast-induced nephropathy in patients with chronic kidney disease. Circulation 2007; 115: 3189-3196

Contact:

Bracco Diagnostics Inc. Michael Ramalho, 609-514-2504 michael.ramalho@diag.bracco.com

Source: Bracco Imaging


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