Positive Data Used by the FDA to Expand Use of Advair Last Month TORONTO and RESEARCH TRIANGLE PARK, N.C., May 18
TORONTO and RESEARCH TRIANGLE PARK, N.C., May 18 /PRNewswire-FirstCall/ --
The use of Advair Diskus(R) 250/50 (fluticasone propionate and salmeterol
inhalation powder) demonstrated a 30% reduction in exacerbations in patients
with chronic obstructive pulmonary disease (COPD) who have a history of
exacerbations as compared with salmeterol alone, according to new data
presented today at the International Conference of the American Thoracic
Society meeting in Toronto.
COPD is a progressive, life-threatening lung disease that includes chronic
bronchitis, emphysema or both. Exacerbations are flare-ups or episodes of
worsening COPD symptoms that often require additional treatment, such as
antibiotics, oral corticosteroids and in some cases hospitalization. Symptoms
may include shortness of breath, or coughing up excess mucus beyond normal
day-to-day variations. Seventy-seven (77) percent of patients with COPD report
experiencing at least one exacerbation within the past year.
The randomized study of 797 patients was a replicate study which found
that after a year of treatment, patients treated with Advair Diskus 250/50 had
a 30% reduction in the rate of annual exacerbations compared to salmeterol
(p<0.001). In an analysis of time to first moderate/severe exacerbation,
there was a 25 percent reduction in risk with Advair compared to salmeterol
(p=0.003). And Advair also reduced the annual rate of exacerbations requiring
oral corticosteroids by 40 percent (p<0.001).
The study was one of two new studies reviewed by the U.S. Food and Drug
Administration prior to granting approval last month for the expanded use of
Advair for the reduction of COPD exacerbations in patients with a history of
exacerbations and in a broader COPD patient population which includes patients
with chronic bronchitis, emphysema or both. The studies conducted to support
the new indication were one year in duration thus lengthening the duration of
established efficacy and safety.
"Reducing exacerbations is one of the primary goals of COPD treatment, and
this second study presented today shows convincingly that Advair effectively
addresses this pressing need," said Antonio Anzueto, MD, University of Texas
Health Science Center. "This data reaffirms my belief in Advair as an
effective treatment for my patients with COPD."
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.
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 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. 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.
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.
SOURCE GlaxoSmithKline
