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Asthma Patients Not Adequately Controlled on ICS Alone More Likely to Benefit From Advair(R) Than Doubling the Dose of ICS
Date:5/20/2008

Findings of Observational Study Presented at American Thoracic Society

Annual Meeting

RESEARCH TRIANGLE PARK, N.C. and TORONTO, May 20 /PRNewswire/ -- Patients with asthma not adequately controlled on the inhaled corticosteroid fluticasone propionate (FP) alone experienced significant reduction in severe exacerbations when switched to the equivalent dose of FP combined with salmeterol administered as Advair Diskus(R) (fluticasone propionate and salmeterol inhalation powder) compared with patients who received a double dose of FP. The findings from an observational study were presented today at the International Conference of the American Thoracic Society meeting in Toronto.

Researchers analyzed more than 5 years of data from a health insurance claims database and identified 1,904 patients uncontrolled on an inhaled corticosteroid alone. The study found patients who were switched to Advair were 36 percent less likely to suffer a severe asthma exacerbation defined by treatment with oral or injected steroid, an emergency-department (ED) visit or hospital admission (p<0.001) than those who received double dose FP. In an analysis of only ED visits and hospitalizations, the number of events was too infrequent in both treatment groups to show a statistical difference, however the rate of these events was lower in patients treated with Advair (5.2%) versus FP (7.6%).

Additionally, patients switched to Advair needed 34 percent fewer prescriptions for albuterol, a short-acting beta-agonist also known as a rescue inhaler (p<0.001). Results were similar regardless of the starting dose of FP.

Advair combines two medications in one device to help prevent and control asthma symptoms. Asthma causes inflammation (swelling in the airways) and airway constriction (the tightening of muscles that surround the airways), and Advair contains both an inhaled corticosteroid, fluticasone propionate, to reduce inflammation; and an inhaled long-acting bronchodilator, salmeterol, to help prevent and reduce airway constriction. Advair is for people who still have symptoms on another asthma controller, or whose disease severity clearly warrants treatment with two maintenance therapies.

About Observational Studies

This was an observational study. Unlike randomized controlled trials, observational studies such as these do not imply causality, though they can imply association of the treatment to the outcome. Even though outcomes were adjusted for severity using known subject demographics, asthma-related outcomes are influenced by many factors, such as prescriber and clinical factors. These factors were not measured or evaluated in this study.

Important Information about Advair

Advair won't replace fast-acting inhalers for sudden symptoms and should not be taken more than twice a day. Advair contains salmeterol. In patients with asthma, medicines like salmeterol may increase the chance of asthma-related death. So Advair 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. People taking Advair should see their doctor if their asthma does not improve. Thrush in the mouth and throat may occur. 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. Advair HFA is for patients 12 years and older.

For more information about Advair please visit http://www.gsk.com.

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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