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GlaxoSmithKline Statement on FDA Advisory Committee Vote on Use of Asthma Medicines Containing Long-Acting Beta-Agonists
Date:12/11/2008

ol with Advair than with a single medicine. Improvements with Advair included better lung function and symptom control and a reduction in albuterol use.

-- For Advair, there was no evidence of increased risk for asthma-related death, hospitalization, and intubation as well as all cause death in any age group compared to other treatments studied.

-- The analysis showed no increased risk of serious asthma-related events when salmeterol is used appropriately with an ICS. In fact, the combination of salmeterol with an ICS (either as Advair or as Serevent plus an ICS) provides effective asthma control to patients by improving lung function, preventing daytime and nighttime symptoms and decreasing the use of rescue medications -- all important measures of asthma control.

-- There were no asthma-related deaths in children receiving Serevent or Advair in clinical studies enrolling more than 7,400 children.

-- There was an increased risk for serious asthma-related outcomes, including hospitalization, when salmeterol was used without an inhaled corticosteroid or when the use of inhaled corticosteroids could not be assured (e.g. not part of study treatment).

-- Asthma is a significant public health issue in the U.S. The disease affects more than 22 million people, including more than 6 million children. Uncontrolled asthma can put patients at risk for increased asthma symptoms, sudden attacks, hospitalization and death.

Important Information about Advair Diskus

Advair Diskus is indicated for the maintenance treatment of asthma. Advair Diskus won't replace fast-acting inhalers for sudden symptoms and should not be taken more than twice a day. Advair Diskus contains salmeterol. In patients with asthma, medicines like salmeterol may increase the chance of asthma-related death. So Advair Diskus is not for people whose asthma is well controlled on another control
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SOURCE GlaxoSmithKline
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