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Results From One-Year Study Suggest Advair(R) Provides Important Benefits for African American Patients With Asthma
Date:6/10/2008

Results Suggested Improvements in Several Endpoints for Advair Diskus(R)

Compared to ICS Alone

RESEARCH TRIANGLE PARK, N.C., June 10 /PRNewswire/ -- African American patients with asthma treated with Advair Diskus, a combination of the long-acting beta-agonist (LABA) salmeterol and the inhaled corticosteroid (ICS) fluticasone propionate, had a lower rate of exacerbations when compared with patients who received treatment with the ICS Flovent Diskus(R) (fluticasone propionate inhalation powder) alone, although the difference was not statistically significant. Patients in the Advair group also showed improvements in lung function measures, nighttime awakenings due to asthma, and reductions in daily symptoms and rescue inhaler use compared to Flovent. The data was published in the June 2008 issue of Current Medical Research and Opinion.

This large prospective trial, which followed 475 patients who received either twice-daily Advair Diskus 100/50 (fluticasone propionate and salmeterol inhalation powder) or twice-daily Flovent Diskus 100mcg for a year, was the first prospective study to assess the addition of a LABA to an ICS compared to ICS alone in African Americans with persistent asthma.

In this study, Advair provided important benefits to patients and no increased rate of adverse events compared with Flovent in the African American patient population. The findings of the study also contribute to the body of evidence which has found that salmeterol (a LABA) is not associated with an increase in serious asthma-related events when used with an ICS, but rather provides clinical benefits for patients who require more than ICS treatment alone to control their asthma.

"Uncontrolled asthma is a critical public health issue for African Americans, and this research is reassuring for clinicians whose patients are not controlled on an ICS alone that treatment with Advair helps improve day-to-day asthma control," said William Bailey, M.D., lead author and Director of the Lung Health Center at the University of Alabama at Birmingham. "Preventing exacerbations and improving lung function are important goals of asthma management."

Current treatment guidelines recommend the addition of a LABA to an ICS in patients with moderate to severe asthma who are uncontrolled on an ICS alone. Taken in combination, an ICS and LABA fight the two main components of asthma -- inflammation (swelling in the airways) and airway constriction (the tightening of muscles that surround the airways). Inhaled corticosteroids treat the inflammation, while LABAs treat the airway constriction. Optimal therapy for many patients with persistent moderate to severe asthma requires treatment of both these components.

The study was designed to primarily show that Advair improved the rate of exacerbations compared to Flovent. While Advair patients had a lower exacerbation rate than those patients in the Flovent group, the difference was not statistically significant. On most of the secondary endpoints, patients given Advair performed better than patients who used Flovent. Forced expiratory volume in one second (FEV1) improved in Advair patients. Both morning and evening peak expiratory flow (PEF) were also improved in the Advair group. Patients using Advair were also less likely to awake at night due to asthma-related breathing difficulties. Additionally, the Advair group showed reductions in the rate of daily symptoms and the need for a rescue inhaler.

Both Advair and Flovent were well tolerated. Over a one-year period, the overall incidence of adverse events was similar between the two groups.

Important Information about Advair Diskus

Advair Diskus won't replace fast-acting inhalers for sudden symptoms and should not be taken more than twice a day. Advair Diskus contains salmeterol. In patients with asthma, medicines like salmeterol may increase the chance of asthma-related death. So Advair Diskus is not for people whose asthma is well controlled on another controller medicine. People should speak to their doctor about the risks and benefits of treating their asthma with Advair Diskus. People taking Advair Diskus should see their doctor if their asthma does not improve. People should tell their doctor if they have a heart condition or high blood pressure. Some people may experience increased blood pressure, heart rate, or changes in heart rhythm. Advair Diskus is for patients 4 years and older. For patients 4 to 11 years old, Advair Diskus 100/50 is for those who have asthma symptoms while on an inhaled corticosteroid.

About GlaxoSmithKline

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit http://www.gsk.com.


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SOURCE GlaxoSmithKline
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