Advair 250/50 Now the Only Treatment Approved to Both Reduce Exacerbations
and Improve Lung Function
RESEARCH TRIANGLE PARK, N.C., April 30 /PRNewswire-FirstCall/ -- The
U.S. Food and Drug Administration today approved Advair Diskus(R) 250/50
(fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)
for the reduction of exacerbations in patients with chronic obstructive
pulmonary disease (COPD) who have a history of exacerbations. With this
approval, Advair becomes the only treatment FDA has approved to reduce COPD
exacerbations. Treatment guidelines for COPD state that the reduction of
exacerbations is a key goal in managing the disease.
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 coughing, 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.
"This is good news for my patients with COPD because Advair now brings
an additional benefit in managing their disease," said Gary Ferguson, MD,
Pulmonary Research Institute of Southeast Michigan. "My goal as a physician
is to help reduce the number of exacerbations my patients experience and
Advair 250/50 will be a critical treatment in helping meet that goal."
The FDA also expanded the use of Advair Diskus 250/50 to a broader
patient population which includes not only patients with COPD associated
with chronic bronchitis, but also emphysema or both conditions. Advair
250/50 is the only approved strength for COPD in the U.S., because an
efficacy advantage of the higher strength over Advair 250/50 has not been
demonstrated.
Advair contains two medicines, an inhaled corticosteroid (fluticasone
propionate) and a long-acting beta-agonist (salmeterol), that work together
to improve lung function and reduce exacerbations, two primary goals in the
management of COPD.
Clinical Data
Two identical one-year studies were conducted to evaluate the effect on
COPD exacerbations with Advair Diskus 250/50 compared to 50 mcg of
salmeterol alone, each given twice daily. A total of 1,579 patients with an
established history of COPD exacerbations were enrolled. Patients treated
with Advair Diskus 250/50 had a 30% reduction in the rate of annual
exacerbations compared to salmeterol (p<0.001). Additionally, patients
treated with Advair had a significantly lower annual rate of exacerbations
requiring treatment with oral corticosteroids compared with patients
treated with salmeterol (39.7% reduction [95% CI: 22.8, 52.9], p <0.001).
Secondary endpoints including pulmonary function and symptom scores
improved more in patients treated with Advair 250/50 than with salmeterol
50 mcg in both studies.
The studies conducted to support the new indication were one year in
duration, thus lengthening the duration of established efficacy and safety
in patients with 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 that
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 was originally approved in 2003 for the
maintenance treatment of airflow obstruction in patients with COPD
associated with chronic bronchitis. With the new approval, 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
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