Contact:
Michael Blash
Zeneca Pharmaceuticals
302-886-5465
[email protected]
Suzanne Ross
312-494-4252
FOR IMMEDIATE RELEASE
CLINICAL STUDY DATA FOR ACCOLATE SHOWS IMPROVEMENTS IN QUALITY-OF-LIFE MEASUREMENTS FOR ASTHMA PATIENTS
CHICAGO-April 28, 1998-The oral asthma controller therapy, ACCOLATE (zafirlukast), from Zeneca Pharmaceuticals demonstrated significant improvements in quality-of-life (QOL) scores in patients with moderate asthma, according to study data presented Monday at the American Lung Association/American Thoracic Society annual meeting.
In a 13-week, double-blind, placebo-controlled trial of 454 patients, trial participants on therapy with ACCOLATE (n=231) experienced significant improvements from screen to end point in all four QOL domains (symptoms, activity limitations, emotional function, and exposure to environmental stimuli) measured in the study and the overall QOL score. These findings were supported by treatment differences favoring ACCOLATE over placebo for the percentage of symptom-free days (9.1% vs 6.4%, p=0.05) and problem-free days (53.2% vs 43.0%, p=0.001) during the double-blind treatment period.
In this study "'a greater percentage of patients on ACCOLATE showed a clinically significant improvement in these quality-of-life measurements than those on placebo. By helping to control patients' asthma symptoms, ACCOLATE improved their quality of life," said study co-author Catherine Bonuccelli, M.D., Medical Director, Zeneca Pharmaceuticals. "Our findings suggest that ACCOLATE may reduce the impact that asthma has on patients' lives."
BACKGROUND ON ACCOLATE In November 1996, Zeneca Pharmaceuticals introduced ACCOLATE, a leukotriene receptor antagonist (LTRA), which was the first product in the newest class of asthma drugs approved by the Food and Drug Administration. Through March 1998, ACCOLATE was prescribed more than 2.3 million times to patients ages 12 years and older for the preventive and chronic treatment of asthma, making it the leading antileukotriene agent.
The introduction of this newest class of medications has had a positive impact on how physicians approach the management of asthma symptoms. LTRAs help to control asthma symptoms, rather than treating an attack when it occurs. Leukotrienes are chemicals produced within the body that can cause airway constriction, swelling, mucous production, and influx of inflammatory cells in the lungs, all of which contribute to the signs and symptoms of asthma. Therefore, blocking leukotrienes may inhibit their ability to cause asthma symptoms in many patients. It has also been shown that steroids--which have long been a standard treatment prescribed to control asthma symptoms--do not block the action of leukotrienes.
Although inhaled asthma drugs can be effective, compliance--the amount of drug a patient actually takes--has been shown to vary widely. One clinical study of therapy with ACCOLATE demonstrated an 80 percent compliance rate for patients taking the drug.
More than 14.5 million Americans live with asthma, a chronic, sometimes fatal, lung disease. ACCOLATE is an oral controller agent taken twice daily even during symptom-free periods, either one hour before or two hours after meals, and should not be used to reverse a sudden asthma attack. ACCOLATE is generally well tolerated by most patients. Patients should consult with their doctors before changing their current asthma medications, if they are prescribed a blood thinner, if they are nursing, or if their medical condition worsens. Side effects may include headache, infection, and nausea.
Zeneca Pharmaceuticals is a business unit of Zeneca Inc., a $3.4 billion bioscience business with approximately 7,200 employees in the United States. Zeneca Inc. is a wholly-owned subsidiary of the U.K.-based Zeneca Group PLC (NYSE:ZEN), a major $8.6 billion international bioscience business engaged in the research, development, manufacturing, and marketing of ethical (prescription) pharmaceuticals, agricultural and specialty chemical products, and the supply of health care services.
1. QOL assessments based on "The Asthma Quality of Life Questionnaire." Developed by E. Juniper. 2. Patient demonstrates no daytime symptoms. 3. Patient demonstrates only mild daytime symptoms. 4. (greater than or equal to 0.5 unit change from baseline) 5. Physician Drug & Diagnosis Audit (PDDA) and Source Prescription Audit (SPA), Weekly Retail Prescriptions, November 1996 - February 1998, Scott-Levin, a division of PMSI, Scott-Levin, Inc. 6. Chmelik F, Kao N. Compliance with Asthma Therapy-Measurement and Implications. Clinical Immunotherapeutics. 5(3): 193-204, 1996 March. 7. Chung KF, Kennelly JC, Summerton L, and Harris A. Compliance with an oral asthma treatment: electronic monitoring of twice daily dosing with zafirlukast. Abstract of the 16th International Congress of Allergology and Clinical Immunology, Cancun, Mexico 19-24 October 1997.
NOTE: For full prescribing information for ACCOLATE, please call Michael Blash at 302-886-5465 or access the World Wide Web at www.accolateinfo.com.
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