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MAY 2004
Baxter's ARALAST
May Positively Impact Life Expectancy in Patients with Hereditary Emphysema
Data Point to Importance of Diagnosis and Treatment of Debilitating Condition
DEERFIELD, Ill., May 25, 2004 - Data were presented today at the annual meeting of the American Thoracic Society demonstrating that the use of Baxter Healthcare Corporation's ARALAST (alpha1-proteinase inhibitor (human)) in the treatment of hereditary emphysema may positively impact life expectancy.
The study, which included data from Phase III clinical trials of ARALAST and other published literature, employed an analytic simulation model to understand the impact on life expectancy of augmentation therapy with ARALAST versus no augmentation therapy in patients with alpha1-antitrypsin (AAT) deficiency associated with hereditary emphysema. "Hereditary emphysema is an underdiagnosed and disabling condition," said David Sclar, Ph.D., Boeing Distinguished professor of Health Policy and Administration and director of the Pharmacoeconomics and Pharmacoepidemiology Research Unit at Washington State University . "It is estimated that only about five percent of patients with this condition have been diagnosed in the United States . As a result, many of these patients experience complications and a shortened life expectancy and would benefit from using a therapy like ARALAST."
The statistical analysis in this study used the ARALAST clinical trial data and other published studies to establish the absolute relative-risk for specific endpoints, including the need for a lung transplant and infections. A decision-analytical framework (Monte Carlo simulation) provided parameters to analyze mean life-years gained with the use of Aralast compared to no treatment for AAT deficiency. Overall, augmentation therapy with ARALAST was associated with a significant increase (p<0.05) in years of life gained, ranging from 5.93 to 10.6 years, depending on gender and smoking status. "We are committed to understanding this debilitating condition and helping emphasize the importance of diagnosis and treatment," said David Gelmont, MD, medical director, Global Research & Development in Baxter's BioScience business. "Hereditary emphysema is a condition that requires therapy to prevent further progression of this disease. These data presented today offer some perspective on the benefits of a therapy like ARALAST. These results also highlight the importance of diagnosing patients with this condition so that they have the option of receiving treatment." ARALAST is a human alpha1 - proteinase inhibitor (A1PI) indicated for the treatment of hereditary emphysema, which is a genetic condition caused by a deficiency of alpha1 antitrypsin (AAT) in the lungs. People with this deficiency have reduced serum levels of AAT, an important blood protein processed in the liver that can protect lung tissue from damage caused by enzymes that are released by white blood cells.
According to the Alpha-1 Foundation, AAT deficiency affects an estimated 100,000 people in the United States . It is estimated more than 95 percent of those with AAT deficiency are undiagnosed. Without sufficient quantities of AAT, patients develop lung damage. If untreated, AAT deficiency can result in emphysema and premature death. AAT deficiency should be treated by a weekly infusion of an A1PI like ARALAST.
This therapeutic approach is not a cure nor will it reverse lung damage that has already occurred. However, it does protect the lungs from further damage, making early diagnosis and treatment desirable. For more information on ARALAST, including full prescribing information, please visit http://www.aralast.com. Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter assists health-care professionals and their patients with treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients´ lives. For more information about Baxter, please visit http://www.baxter.com.
Baxter and ARALAST are trademarks of Baxter International Inc. and its affiliates.
Telephone: 540-948-6777 or 1-866-FOR-A1AA (1-866-367-2122) Fax # 540-948-6763
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