BUCKINGHAMSHIRE, U.K., Nov. 19, 2003 (PRIMEZONE) -- The findings of a Duke University study abstract that were reported at the American Heart Association meeting November 9-12 in Orlando, Florida, indicated that the use of Visipaque(TM) (iodixanol), a diagnostic pharmaceutical produced by Amersham plc (LSEAHM) (NYSE:AHM) (OSE:AHM), was found to have a significantly lower incidence of in-hospital major adverse cardiac events (MACE) compared to Isovue(R) (iopamidol) in patients who undergo an interventional therapeutic cardiac procedure.Visipaque(TM) is a nonionic, isosmolar contrast medium used to provide enhanced X-ray images of soft tissues, primarily blood vessels and organs, for the diagnosis of many common diseases.
The data of the VICC trial (Visipaque(TM) vs. Isovue(R) in Cardiac Catheterization) show a significantly lower incidence of cardiac complications, including myocardial infarction (MI), following percutaneous coronary intervention (PCI) procedures using the isosmolar, nonionic contrast medium, Visipaque(TM), when compared to the low osmolar, nonionic, contrast medium Isovue. MI, following PCI, is a serious complication associated with 5% to 10% of PCI procedures.
The VICC trial was a multi-center randomized double-blinded study involving 1,276 patients who underwent PCI. J. Kevin Harrison, MD, of Duke University was the study's primary investigator. The VICC trial was sponsored by Bracco Diagnostics Inc., manufacturer of Isovue(R).
As presented in the abstract, the data show that patients receiving Visipaque(TM) experienced fewer MACE, including MI, when compared to patients receiving Isovue in the 48-hour period immediately following PCI. In addition, during the entire 30 days after their PCI procedure, there were significantly fewer MI events for patients receiving Visipaque(TM) versus Isovue(R).
The data of the VICC trial complement the outcome of the earlier COURT trial (A Randomized Trial of Contrast Media Utilization in High Risk PTCA), comparing nonionic, isosmolar Visipaque(TM) with an ionic, low osmolar agent Hexabrix(TM) (ioxaglate meglumine 39.3% and ioxaglate sodium 19.6%). Published in the May 9, 2000, issue of Circulation (the scientific journal of the American Heart Association), the COURT trial indicated that cardiac patients receiving Visipaque(TM) had a 45% reduction of major adverse cardiac events compared to Hexabrix(TM).
Daniel L. Peters, President of Amersham Health's Medical Diagnostics business, said: "We are pleased that the results of the VICC trial, which are compatible with those of the COURT Trial, further establish the clinical benefits of using Visipaque(TM) in reducing major adverse clinical events in patients undergoing PCI."
About Amersham
Amersham is a world leader in medical diagnostics and in life sciences. Headquartered in the UK, the company had annual sales of 1.62 billion Pounds in 2002 and over 10,000 employees worldwide. Its strategy is to build its position as a leading provider of products and technologies enabling disease to be better understood, diagnosed earlier and treated more effectively.
For additional information and full prescribing information, visit the Amersham Health Web site at www.amershamhealth.com or the Amersham corporate Web site at www.amersham.com
About Amersham Health
Amersham Health, a business of Amersham, is a leading global pharmaceutical provider of diagnostic and predictive imaging products and services. Amersham Health is dedicated to providing health care professionals with products that expand and improve their diagnostic capabilities and contribute to the treatment of disease. Amersham Health is committed to finding innovative diagnostic and therapeutic solutions with a focus on cardiology, neurology and cancer. Every single second one of Amersham Health's products is used around the world to make a difference in a person's life.
For more information about non-ionic, isosmolar Visipaque(TM) and Full Prescribing Information for any Amersham Health product, call +1 800 292 8514 or visit www.amershamhealth-us.com.
Notes to Editor: Reference 1. VICC abstract
Visipaque(TM) is an X-ray/CT product for the diagnosis of a wide range of diseases including coronary heart disease and to aid in stent placement. The only contrast media available for intravascular use that is nonionic and isosmolar (has the same osmolality as blood) at all iodine concentrations. It is also formulated to be isosmolar with the important electrolytes sodium and calcium. This means the product is more in balance with the body providing an extra margin of patient comfort and safety.
In the U.S., Visipaque(TM) is Not for Intrathecal Use. All nonionic, iodinated contrast media currently available 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 to minimize thromboembolic events.
Caution must be exercised in patients with severely impaired renal function, combined renal and hepatic disease, combined renal and cardiac disease, severe thyrotoxlcosis myelomatosis, or anuria, particularly when large doses are administered. (See PRECAUTIONS).
Medical diagnostics: Contrast media and radiopharmaceuticals used in medical diagnostic procedures to enhance images and provide information about the structure and function of organs, tissues and molecules in the body, enabling early, accurate diagnosis and management of disease.
The VICC trial was a multi-center randomized double-blinded study involving 1,276 patients who underwent PCI at nine medical facilities in the United States. The primary endpoint was the number of in-hospital MACE. The secondary end point was the number of 30 day MACE.
PCI is a procedure in which various catheter devices are used to unclog blocked arteries of the heart. It is estimated that, on a global basis, approximately 2 million PCI procedures are performed annually, with 1 million performed in the US.
Hexabrix (ioxaglate) is licensed by and a registered trademark of Guerbet, S.A. Isovue (iopamidol) 370 is a registered trademark of Bracco, S.p.A.