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Study Found That Long Term Use of Advair Diskus(R) 250/50 Did Not Adversely Affect Bone Loss in Patients with COPD
Date:10/29/2008

- Study showed no consistent differences in bone mineral density at the lumbar spine and total hip between Advair Diskus 250/50 (fluticasone propionate and salmeterol inhalation powder) and salmeterol

- Study provides support for long term use of Advair(R) in patients with COPD

PHILADELPHIA, Oct. 29 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announced today that data from a three-year study of patients with Chronic Obstructive Pulmonary Disease (COPD) found that the inhaled corticosteroid in Advair Diskus 250/50, fluticasone propionate, did not show an adverse effect on bone mineral density (BMD) measured at the lumbar spine and total hip compared to salmeterol alone. In this study, designed to show equivalent rate of change in BMD for Advair and salmeterol, results for bone mineral density in the lumbar spine did not meet clinical equivalence although the rate of change favored Advair. The data was presented in Philadelphia at CHEST 2008, the annual meeting of the American College of Chest Physicians.

"These data are very encouraging for patients with COPD since most patients with this debilitating disease are at an age where they may also be at risk for bone loss," said Richard ZuWallack, MD of St. Francis Hospital and Medical Center, Hartford CT. "These data inform on the long-term impact of inhaled corticosteroids on bone mineral density."

About the Study

Effects of treatment with Advair Diskus 250/50 or salmeterol 50 mcg on BMD were evaluated in 186 patients (females and males 43 to 87 years of age) with COPD in a 3-year double-blind study. BMD evaluations were conducted at baseline and at 6-month intervals. The study was designed to show equivalence in the rate of change of BMD at the L1-L4 lumbar spine and total hip between Advair and salmeterol (defined as a difference in BMD of +/-1% per year). The difference in the rate of change of BMD for Advair versus salmeterol at the lumbar spine was +0.8% per year (95% CI: 0.06, 1.49). The study was powered for equivalence but instead showed a trend favoring Advair. The study showed equivalence between the two groups in the rate of change at the hip (-0.3% per year (95% CI: -0.78, 0.24)).

In summary, the study showed no adverse effect on BMD attributable to the corticosteroid component of Advair, and provides support for the long term use of Advair in patients with COPD.

About Advair in COPD

Advair Diskus 250/50 was approved in 2003 for COPD. Advair Diskus 250/50 is currently indicated for the twice-daily 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 of COPD in patients with a history of exacerbations. Advair Diskus 250/50 is the only approved dosage for the treatment of 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. 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 that makes it difficult to breathe. Many 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.

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2007.

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SOURCE GlaxoSmithKline
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