Analysis Showed No Increased Risk of Hospitalization in Patients When Adding a LABA to ICS Compared to ICS Alone

- Adding a LABA to ICS Also Decreased Risk of Asthma Exacerbations Versus ICS Alone -

RESEARCH TRIANGLE PARK, N.C., June 02, 2008 /PRNewswire-FirstCall/ -- A meta-analysis of 66 studies involving more than 20,000 asthma patients found that patients treated with both the long-acting beta-agonist (LABA) medication, salmeterol, plus an inhaled corticosteroid (ICS) were at no increased risk for hospitalization than patients using an inhaled steroid alone. A subset analysis also found that patients treated with the combination of a LABA and an ICS were significantly less likely to experience a severe exacerbation than patients using an ICS alone. The results were published today, June 2, 2008, in the online edition of the Annals of Internal Medicine.

A primary goal of asthma therapy is to prevent exacerbations of the disease, in which patients suffer acute periods of worsening asthma symptoms that may require additional treatment, usually with systemic steroids, or hospitalization. Findings from the study support that patients with moderate to severe asthma are significantly more likely to minimize severe asthma exacerbations when using combination therapy without increasing the risk of asthma-related hospitalization.

These findings contribute to a body of evidence (1, 2, 3, 4, 5) which has found that salmeterol is not associated with an increase in serious asthma-related events when used with an ICS, but rather provides significant clinical benefits for patients who require more than ICS treatment alone to control their asthma. This retrospective analysis was undertaken to examine the effects of salmeterol (LABA) when used not as mono-therapy, but along with ICS. This use is consistent with current treatment guidelines and product labeling for LABA-containing products in the treatment of asthma.

In the 66 randomized, controlled studies reviewed by the authors, 35 of the 10,400 patients who received combination therapy experienced an asthma-related hospitalization, compared to 34 of the 10,566 patients who received an inhaled steroid alone.

The study also found that 175 of 3,541 (4.9%) patients receiving a LABA plus ICS experienced a severe exacerbation compared with 334 of 4,008 (8.3%) patients receiving an ICS alone, suggesting that combination therapy provides better asthma control than ICS alone. The findings are consistent with national and international treatment guidelines that state LABAs should be used concurrently with ICS in treating patients with moderate to severe asthma who are uncontrolled on an ICS alone.

In the study, there was one asthma-related death and one intubation in the LABA plus ICS group. This suggests that adding a LABA to an ICS may not affect or increase the risk of asthma-related death or intubation compared to ICS alone.

Taken in combination, an ICS and LABA fight the two major causes of asthma -- inflammation (swelling in the airways) and airway constriction (the tightening of muscles that surround the airways). Inhaled corticosteroids treat the inflammation, while LABAs treat the airway constriction.

About the Study Selection

The analysis included 66 randomized, controlled trials conducted by GSK that compared the ICS fluticasone propionate plus salmeterol administered in a single device, as Advair, or an ICS and salmeterol administered in separate devices versus ICS alone. The study involved 20,966 participants with persistent asthma. The analysis looked at studies with durations of 1 week to 52 weeks. The median study duration was 12 weeks.

About Advair Diskus

Advair Diskus(R), a fixed-dose treatment, combines two medications in one device to help prevent and control asthma symptoms. Advair(R) contains both the inhaled corticosteroid, fluticasone propionate, to reduce inflammation; and an inhaled long-acting bronchodilator, salmeterol, to help prevent and reduce airway constriction. Advair is for people who still have symptoms on another asthma controller, or whose disease severity clearly warrants treatment with two maintenance therapies.

Important Information about Advair Diskus

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 controller medicine. People should speak to their doctor about the risks and benefits of treating their asthma with Advair Diskus. People taking Advair Diskus should see their doctor if their asthma does not improve. People should tell their doctor if they have a heart condition or high blood pressure. Some people may experience increased blood pressure, heart rate, or changes in heart rhythm. Advair Diskus is for patients 4 years and older. For patients 4 to 11 years old, Advair Diskus 100/50 is for those who have asthma symptoms while on an inhaled corticosteroid.

About Meta-Analysis

Large-scale, long-term, prospective clinical trials in patients with the disease, with a specific outcome as the endpoint are generally accepted as the most scientifically rigorous way to examine the safety and benefits of a medicine. Meta-analyses can be effective at comparing results from similar studies and providing additional information on clinical trial outcomes. Meta-analyses can inform on clinical questions and frequently show findings that generate hypotheses suggesting further investigation -- they generally are not be used to form firm conclusions.

About GlaxoSmithKline

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.

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Posted: June 2008

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