New Study Shows Accolate Offers Effective Alternative to Increased Dosing of Inhaled Corticosteroids in Asthma

Contact:
Michael Blash
Zeneca Pharmaceuticals
302-886-5465
[email protected]

Suzanne Ross
312-494-4252

FOR IMMEDIATE RELEASE

NEW STUDY SHOWS ACCOLATE OFFERS EFFECTIVE ALTERNATIVE TO INCREASED DOSING OF INHALED CORTICOSTEROIDS IN ASTHMA PATIENTS
Oral Therapy Improves Asthma in Symptomatic Patients on Low-Dose Inhaled Corticosteroids

WASHINGTON--March 17, 1998--Results of a new study demonstrate ACCOLATE (zafirlukast), the oral asthma controller therapy from Zeneca Pharmaceuticals, may have a positive additive effect for symptomatic asthma patients on low-dose inhaled corticosteroids. The study data were introduced today in a scientific presentation at the 54th annual meeting of the American Academy of Allergy, Asthma & Immunology.

"Our research demonstrates ACCOLATE may be as effective as doubling the dose of inhaled corticosteroids in patients who experience asthma symptoms while on low-dose inhaled corticosteroids," said Dr. Anjuli Nayak of the Asthma and Allergy Research Group in Normal, Ill., and lead researcher of the study. "ACCOLATE may offer an oral alternative to increasing inhaled corticosteroids."

In this double-blind, double-dummy, 13-week, parallel-group trial, patients 12 years and older on low-dose corticosteroids (L-DICS) were randomized to treatment groups receiving (L-DICS) plus 40 mg of ACCOLATE twice a day, (L-DICS) plus 80 mg of ACCOLATE twice a day, or with a double (D-DICS) dose of inhaled corticosteroids. The objective of the study was to examine the effectiveness of adding ACCOLATE to the treatment regimen of patients with asthma who are symptomatic on low-dose inhaled corticosteroids.

After 13 weeks, all groups showed improvement with reduced occurrence of asthma symptoms. Those patients receiving ACCOLATE showed equal improvements to those patients on double-dose inhaled corticosteroids. Safety parameters were also similar.

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 February 1998, ACCOLATE was prescribed more than two 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 cause an inflammatory reaction in the lungs. When these leukotrienes contribute to airway inflammation, flare up of asthma symptoms may result. Thus, blocking the actions of leukotrienes inhibits 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. It has also been shown that steroids do not inhibit the synthesis of leukotrienes, which contribute to asthma symptoms. Thus, antileukotriene agents can work together with corticosteroids in asthma management. In addition, experts generally agree that oral, tablet-form medications may have a positive effect on how patients comply with their treatment.

More than 14.5 million Americans live with asthma, a chronic, sometimes fatal, lung disease. ACCOLATE is a daily controller agent and should not be used to reverse the symptoms of 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.

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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