Healthcare Industry News:  Medrad 

Biopharmaceuticals Radiology

 News Release - October 31, 2006

The Latest Head-to-Head Clinical Study Comparing the Risk of CIN between Two Contrast Agents Used in CE-MDCT Examinations Was Published in Investigative Radiology

PRINCETON, N.J.--(HSMN NewsFeed)--The results of a clinical study comparing Isovue®-370 (iopamidol injection), marketed by Bracco Diagnostics Inc. in the United States, and Visipaque(TM)-320 (iodixanol injection), marketed by GE Healthcare in the United States, in renally Impaired Patients undergoing Computed Tomography (IMPACT) showed no significant difference in the rate of contrast-induced nephropathy (CIN) between the two agents.

"Our conclusions in this study were that the rate of contrast-induced nephrotoxicity is low and not significantly different in patients with moderate-to-severe renal impairment after administration of iopamidol-370 or iodixanol-320 for contrast-enhanced multidector CT," explained Richard Katzberg, MD, from the University of California Davis, one of the study's investigators.

The IMPACT study was the first multicenter, double-blind, randomized parallel group study designed to prospectively compare the incidence of CIN after the intravenous injection of equi-iodine doses of iopamidol-370 and iodixanol-320, in 153 patients with moderate-to-severe chronic kidney disease undergoing contrast-enhanced multidetector computed tomography (CE-MDCT). The results of the study indicated that the rate of CIN was not significantly different in these at-risk patients after intravenous administration of either contrast agent for CE-MDCT.

"This study is the most comprehensive, rigorously performed and most definitive to date compared to the sparse data previously available to us," said Dr. Katzberg.

It has been suggested that osmolality of contrast solutions may be a contributing factor to the incidence of CIN; however, this hypothesis is not supported by the findings of this study. Despite differences in osmolality between these two agents (iopamidol-370 796 mOms/kg versus iodixanol-320 290 mOms/kg) the IMPACT study did not show significant differences in CIN rates following their intravenous administration.

The manuscript of the study, entitled "Contrast-Induced Nephropathy in Patients with Chronic Kidney Disease Undergoing Computed Tomography: A Double-Blind Comparison of Iodixanol and Iopamidol" was featured in the November 2006 issue of Investigative Radiology, with noted nephrologist Dr. Brendan Barrett as the lead author.

About Isovue

Isovue® (iopamidol injection) is a safe and effective nonionic contrast medium well established with U.S. clinical experience since 1986. Worldwide, more than 250 million doses of iopamidol have been administered. Indicated for a wide variety of radiological 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 U.S. and is an excellent agent to match the speed and power of MDCT. Isovue-M® is indicated for myleography 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.

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About Bracco

The Bracco Group is a world leading provider in diagnostic imaging, with net sales of about 800 million Euros per year. Bracco has operations in 115 countries and about 2,100 employees, around 300 of whom work in R & D. Bracco invests approximately 15% of its annual turnover in R & D and has a portfolio of 1,500 patents worldwide.

The Bracco Group is a leader in the diagnostic imaging market with an integrated product offering from a diverse roster of subsidiary companies. While Bracco is recognized internationally as a definitive market leader in its core business of contrast media, Bracco also markets key diagnostic imaging resources through the following companies: ACIST Medical Systems, a manufacturer of advanced contrast media injection systems and Singapore-based Volume Interactions, which also produces advanced 3-D medical software.

Bracco also operates a high-level international research network, with three centers (Ivrea, Geneva, and Princeton). These centers develop products of the latest-generation diagnostic techniques, from X-ray and computed tomography (CT), magnetic resonance imaging (MRI), echocontrast and nuclear medicine.

Visipaque is a trademark of GE Healthcare.

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

Source: Bracco Diagnostics

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