Late-Breaking Clinical Trial Results Reveal No Statistically Significant Difference...

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

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 Roentgenology(1) (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(R) -370,
Bracco Diagnostics Inc., Princeton, NJ, 796 mOsm/kg) or the nonionic
dimer iodixanol-320 (Visipaque(TM) 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 Study(2) and the CARE Study(3), 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. PREDICT(1) 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, IMPACT(2), compared the agents following their
intravenous injection in 153 patients with chronic kidney disease
undergoing CT and the second trial, CARE(3), 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(R) (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(R) Pharmacy Bulk package offers multi-dosing efficiency in
200 mL and 500 mL volumes. Isovue(R) Prefilled Syringes for use with
the Medrad(R) 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(R) 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

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

Copyright Business Wire 2008