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Three-Year COPD Study Found No Increase in Cardiac Events With Advair(R) 500/50
Date:5/21/2008

Analysis of Cardiac Adverse Events in TORCH Showed Frequency Highest in

Placebo Group

TORONTO and RESEARCH TRIANGLE PARK, N.C., May 21 /PRNewswire-FirstCall/ -- The use of Advair Diskus(R) 500/50 (fluticasone propionate and salmeterol inhalation powder) was associated with the lowest number of cardiovascular adverse events compared to other treatment arms in a post-hoc analysis of data from the TOwards a Revolution in COPD Health (TORCH) study presented at the International Conference of the American Thoracic Society meeting in Toronto today.

The TORCH study followed more than 6,000 patients with chronic obstructive pulmonary disease (COPD) over a 3-year period. Because cardiovascular mortality is a common cause of death in patients with COPD, investigators assessed how Advair or its component medications affected the rate of cardiac adverse events compared to the individual components and placebo in this analysis.

The results found that 17 percent of patients treated with Advair reported a cardiac adverse event, compared with 21 percent of those in the placebo group, 19 percent of those in the salmeterol group and 20 percent of those in the fluticasone propionate group. The rate of cardiac death was also lower in the Advair arm as compared with the placebo arm (4% vs. 5%).

"Because the TORCH study followed over 6,000 patients for 3 years, it gives us the unique opportunity to look for cardiovascular trends in patients with COPD. After looking closely at all of the data, we certainly do not see any increase in cardiovascular risks associated with Advair or salmeterol," said Gary Ferguson, MD, Pulmonary Research Institute of Southeast Michigan and member of the TORCH steering committee. "In fact, Advair had the lowest number of cardiovascular adverse effects and we see this as an important finding."

Advair contains two medications, an inhaled corticosteroid and a long-acting beta-agonist, that work together to improve lung function and reduce exacerbations, two primary goals in the management of COPD.

About Advair in COPD

Advair Diskus 250/50 is indicated for the maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Advair Diskus 250/50 is also indicated to reduce exacerbations in patients with a history of exacerbations. Advair Diskus 250/50 is the only approved strength for COPD because an efficacy advantage of the higher strength Advair Diskus 500/50 over Advair Diskus 250/50 has not been demonstrated.

Patients should only take one inhalation of Advair twice a day. People with COPD taking Advair may have a higher chance of pneumonia. Patients should call their doctor if they notice any of the following symptoms: change in amount or color of sputum, fever, chills, increased cough, or increased breathing problems. Advair may increase the risk of osteoporosis and some eye problems (cataracts or glaucoma). Patients should have regular eye exams. Thrush in the mouth and throat may occur. Advair should be used with caution in patients with cardiovascular disorders. Patients should tell their doctor if they have a heart condition or high blood pressure before taking Advair. Do not use Advair with long-acting beta2-agonists for any reason. Advair does not replace fast-acting inhalers for sudden symptoms.

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

Background on COPD

An estimated 24 million Americans suffer from COPD, which is the fourth leading cause of death in the United States. COPD is a progressive, life-threatening lung disease that includes chronic bronchitis and emphysema. It is characterized by airflow obstruction, a limitation in lung function, which makes it difficult to breathe. Most patients have components of both chronic bronchitis and emphysema. Symptoms of COPD include chronic cough, chest tightness, shortness of breath, an increased effort to breathe and increased mucus production. Typically, patients with COPD develop shortness of breath during exertion, which continues and gradually worsens. Most patients also develop a productive, chronic cough. Over time, many patients suffer from shortness of breath so severe that it interferes with their most basic daily activities including sleeping, talking, and even dressing. The gradual loss of lung function, coupled with other symptoms and exacerbations, often lead to hospitalization and can be disabling and life-threatening.

About GlaxoSmithKline (NYSE: GSK)

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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