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New Data Show Advair Reduces Asthma-Related Hospitalization and Emergency Department Visits

Two Observational Studies Examine Impact of Advair in Asthma Patients

RESEARCH TRIANGLE PARK, N.C. and PHILADELPHIA, March 15, 2008 /PRNewswire/ -- Advair Diskus(R) (fluticasone propionate and salmeterol inhalation powder) was associated with fewer asthma-related hospitalizations and emergency department (ED) visits in pediatric patients when compared to the use of inhaled corticosteroids (ICS) alone, and use of Advair by pediatric and adult patients through the summer was associated with fewer hospitalizations and ED visits in the fall. The two studies, which examined a large managed care database of more than 45 U.S. health plans, were presented today at the 2008 American Academy of Allergy, Asthma and Immunology annual meeting in Philadelphia.

"These two analyses found that use of Advair was associated with fewer serious outcomes," said Ketan Sheth, M.D., allergist at the Lafayette Allergy and Asthma Clinic in Lafayette, Ind., and lead author on the seasonal study. "An enormous element of the health impact of asthma stems from the high rate of hospitalizations and emergency department visits, so it's critical that we continue to demonstrate that there are interventions that can keep patients out of these serious emergency situations."

Advair Reduces Hospitalizations and ED Visits in Children versus ICS

This was an observational study evaluating the rates of asthma-related hospitalizations and ED visits in children 4 to 11 years of age with persistent asthma. To be considered in the analysis, the child had to have a pharmacy claim for Advair or an inhaled corticosteroid. Medical claims for a 4-year period were then examined to see which children had been hospitalized or required treatment in the ED during the year of treatment.

Those using Advair were significantly less likely to have a hospitalization or an ED visit, with asthma-related hospitalizations in the Advair group at 3.0 visits per 100 patient-years compared with 4.2 visits per 100 patient-years for the inhaled corticosteroid group (p<0.001) and an asthma-related ED event rate of 15.8 visits per 100 patient-years with those using Advair compared with 18 visits per 100 patient-years for inhaled corticosteroids users (p<0.001).

Poor Adherence to Treatment over Summer Months May Increase Severe Outcomes in Fall

The second observational study examined whether the use of Advair during the summer season has an effect on hospitalizations or ED visits in the fall. Asthma-related hospitalizations and ED visits are higher in September, October and November, while these events typically are lowest during the summer months.

Using the same managed care database of more than 45 health plans, researchers found that children, adolescents and adults who used Advair during the summer were significantly less likely to be admitted to the hospital or require treatment in the ED during the subsequent fall months than those who did not receive Advair treatment.

"This seasonal data reinforces that physicians should encourage patients to continue their controller medications during the summer, when asthma events are at their lowest, in order to prevent serious asthma outcomes in the fall," added Sheth.

Advair use was associated with a 57 percent reduction in the risk of an asthma-related hospitalization and a 46 percent reduction in the risk of an ED visit in children 4 to 11 years of age; a 51 percent reduction in the risk of hospitalization and a 41 percent reduction in the risk of an ED visit in adolescents 12 to 18 years of age; and a 39 percent reduction in the risk of hospitalization and a 47 percent reduction in the risk of an ED visit in adult patients 19 to 55 years of age.

Advair Diskus 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.

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. 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.

About Observational Studies

These are observational studies examining the differences in asthma-related emergency department visits and hospitalizations. Unlike randomized controlled trials, observational studies such as these do not imply causality. 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.

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.

CONTACT: US Media, Patty Johnson, +1-919-483-2839, for GlaxoSmithKline

Web site: http://www.gsk.com/

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Posted: March 2008

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