Many Patients Not Receiving Diagnosis or Recommended Therapy

 

SEATTLE, October 25, 2004 – Ongoing treatment with Alpha_1-Proteinase Inhibitor (A_1-PI) augmentation therapy may improve health outcomes and lower healthcare costs for people with alpha_1-antitrypsin (AAT) deficiency (a form of hereditary emphysema), according to data presented today by Baxter Healthcare Corporation at the annual international scientific assembly of the American College of Chest Physicians (ACCP).

Hereditary emphysema is a potentially fatal lung condition caused by a deficiency of alpha_1-antitrypsin, a protective protein in the lungs. The condition is a potentially fatal genetic disorder, yet as many as 95 percent of people with the condition do not know they have the disease or are not receiving recommended treatment.

“Although an estimated 100,000 Americans have AAT deficiency only about 5 percent of those with the disease have been diagnosed, and even fewer are receiving A_1-PI therapy as recommended by the Standards of the American Thoracic Society (ATS) and the European Respiratory Society (ERS),” said Karen Chung, PharmD, MS, Baxter Healthcare Corporation, who presented the study at ACCP.

In the study presented at ACCP, claims for 771 subjects with AAT deficiency were identified in a large healthcare database representing approximately 12 million covered lives. Of these, 197 also had emphysema. Subjects were stratified according to whether they did or did not receive an A_1-PI therapy commercially available in 2002.

A total of 116 (59 percent) received A_1-PI augmentation therapy. A_1-PI subjects were less likely to have received outpatient intravenous antibiotic therapy than subjects not receiving A_1-PI (2 percent versus 14 percent, respectively; p<0.01) and had fewer hospitalizations per subject (0.3 versus 0.8; p<0.01). A_1-PI subjects also were more likely to have received bronchodilators (91 percent versus 64 percent; p<0.01), supplemental oxygen (19 percent versus 4 percent; p<0.01) and inhaled corticosteroids (69 percent versus 44 percent; p<0.01).

“Studies have shown that A_1-PI augmentation therapy may slow the progression of the disease and may increase life expectancy,” said study co-author David Gelmont, M.D., Medical Director, Global Research Development, Baxter. “Consequently, detection and treatment of AAT deficiency is important because the disease is progressive and irreversible. Thus, the earlier people are diagnosed, the sooner they can receive therapy, delay disease progression and potentially improve clinical outcomes.”

AAT is a protein that protects the tissues of the body from enzymes released by white blood cells that, if unchecked, can destroy healthy tissue – most often in the lung and liver.

According to ATS/ERS standards, people who should be tested for AAT deficiency include those with:

• Chronic obstructive pulmonary disease (COPD)
• Onset of pulmonary emphysema at age 45 or younger
• Emphysema in the lower lobes of the lung
• Emphysema without recognized risk factors such as smoking or occupational exposure
• Shortness of breath and cough occurring in multiple family members
• Liver disease of unknown cause
• Bronchiectasis
• Asthma in which spirometry tests fail to return to normal following treatment
• Unexplained panniculitis, a skin disorder
• A family history of AAT deficiency, emphysema, bronchiectasis, liver disease or panniculitis.

 

To improve diagnoses, Baxter has launched a screening program and prevalence study to help identify those at risk.

Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter assists healthcare 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 www.baxter.com.