Contact:
Michael Blash
Zeneca Pharmaceuticals
302-886-5465
[email protected]
Suzanne Ross
312-494-4252
FOR IMMEDIATE RELEASE
NEW RESEARCH SHOWS ACCOLATE REDUCES THE NEED FOR SHORT COURSES OF ORAL CORTICOSTEROID TREATMENT IN ASTHMA PATIENTS
Study Also Concludes Oral Asthma Therapy is Effective First-line Controller Medication
CHICAGO-April 27, 1998-Combined data from an analysis of five clinical studies show that the oral asthma controller therapy, ACCOLATE(tm) (zafirlukast), from Zeneca Pharmaceuticals may reduce the need for short courses of oral steroids in patients experiencing asthma attacks. The study results were presented today in an abstract at the American Lung Association/American Thoracic Society annual meeting in Chicago.
"Our findings emphasize the role of ACCOLATE as an effective first-line controller medication and indicate that ACCOLATE may reduce the need for systemic corticosteroids for asthma exacerbations, which is an outcome of particular importance to asthma patients," said Susanna M. Hassall, BSc, Clinical Project Manager, Zeneca Pharmaceuticals.
Guidelines released last year by the National Institutes of Health (NIH) establish ACCOLATE as a treatment for long-term control in patients with mild, persistent asthma. Severe exacerbations are commonly managed by short courses of oral steroid treatment in patients with mild asthma. Thus, to further investigate the effect of a 20 mg, twice-daily dose of ACCOLATE or the need for oral steroids in response to asthma exacerbations, researchers conducted a meta-analysis across five 13-week, multinational, double-blind, placebo-controlled trials in patients previously receiving only beta2-agonists (reliever medications) as required.
Overall, there was a statistically significant (p<0.05) approximate halving in the risk of requiring oral steroid treatment for exacerbations in patients treated with ACCOLATE compared with placebo-treated patients (odds ratio = 0.57, 95% C.I 0.34 to 0.97). The authors concluded that this emphasizes the role of ACCOLATE as an effective first-line agent for the treatment of asthma.
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, and influx of inflammatory cells in the lungs, all of which can contribute to the signs and symptoms of asthma. Therefore, blocking leukotrienes may inhibit their ability to cause asthma symptoms in many patients.
Although inhaled asthma drugs can be effective, compliance--the amount of drug a patient actually takes--has been shown to vary widely. A previous study showed over 80 percent compliance with therapy using ACCOLATE. It has also been shown that steroids do not block the action of leukotrienes, which contribute to asthma symptoms.
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. Physician Drug & Diagnosis Audit (PDDA) and Source Prescription Audit (SPA), Weekly Retail Prescriptions, November 1996 - March 1998, Scott-Levin, a division of PMSI, Scott-Levin, Inc. 2. Chmelik F, Kao N. Compliance with Asthma Therapy-Measurement and Implications. Clinical Immunotherapeutics. 5(3): 193-204, 1996 March. 3. 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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