Study Found That Long Term Use Of Advair Diskus(R) 250/50 Did Not Adversely Affect Bone Loss In Patients With COPD

GlaxoSmithKline (NYSE:
GSK) announced 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 gsk.



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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