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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
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SOURCE GlaxoSmithKline
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