An observational study of more than 64,000 asthma patients demonstrated that patients receiving treatment with Advair Diskus (fluticasone propionate and salmeterol inhalation powder) had a significant risk reduction in emergency department visits due to asthma versus patients treated with fluticasone propionate (FP) alone.

A second analysis of clinical trials of patients treated with salmeterol plus FP (the components found in Advair) reported fewer asthma exacerbations when compared to patients treated with FP alone. These findings were presented today at the American College of Allergy, Asthma and Immunology (ACAAI) annual scientific meeting in Philadelphia.

"Each year in the US nearly two million asthma patients have to go to the hospital emergency room because of their asthma," said Dr. Kathy Rickard, Vice President Clinical, Respiratory Medicine Development Center (North America), GlaxoSmithKline. "Frequent asthma exacerbations, emergency department visits and hospitalization are signs of uncontrolled asthma and can be avoided with an appropriate asthma management plan. These findings demonstrate that in appropriate patients, combination treatment with a long-acting beta-agonist and an inhaled corticosteroid is an effective option for maintaining control of a patient's asthma."

Use of concurrent therapy, like Advair, is supported by the National Institutes of Health (NIH) Guidelines for the Diagnosis and Management of Asthma, which position an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA) as preferred therapy for patients with moderate to severe persistent asthma.

Advair contains salmeterol. In patients with asthma, medicines like salmeterol may increase the chance of asthma-related death. So Advair is for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or for patients whose disease severity clearly warrants treatment with two maintenance therapies. Advair is not approved for patients whose asthma can be managed with an ICS along with occasional use of short-acting beta-agonists. Advair Diskus is not indicated for the relief of acute bronchospasm.

People should speak to their doctor about the risks and benefits of treating their asthma with Advair. People taking Advair 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 is for patients 4 years and older. For patients 4 to 11 years old, Advair 100/50 is for those who have asthma symptoms while on an inhaled corticosteroid.

Comparison of resource utilization of fluticasone propionate/salmeterol compared with fluticasone propionate alone: analysis of 64,689 real world users

This study, which looked at 64,689 real world users, was designed to compare the rate of hospitalizations and ER visits in patients receiving Advair Diskus (68.9 per cent of subjects) compared with FP alone (31.1per cent of subjects).

The study found that patients treated with FP alone had a significant increase (26 per cent) in their risk for asthma-related ED visits (HR 1.26, 95 per cent CI 1.15, 1.37), a 20 percent increase in all-cause ED visits (HR 1.2, 95 per cent CI 1.16, 1.26) and an 11 percent increase in all-cause admissions (HR 1.11, 95 per cent CI 1.04, 1.18) compared with those treated with Advair Diskus. The risk of an asthma-related admission (HR 1.18, 95 per cent CI 0.95, 1.46) and all-cause intubation (HR 1.27, 95 per cent CI 0.89, 1.81) was higher for patients treated with FP alone but did not reach statistical significance.

The researchers concluded that the use of Advair Diskus in a single device for the treatment of asthma was associated with an improvement in all-cause admissions, all-cause ED visits and asthma-related ED visits compared with treatment with FP alone.

Retrospective review of studies shows that subjects receiving salmeterol plus an ICS have fewer serious asthma exacerbations versus an ICS alone

This analysis of asthma-related exacerbation and hospitalization outcomes for all U.S. GlaxoSmithKline chronic dose asthma studies was conducted to evaluate the exacerbation and hospitalization rates with the long-acting beta2-agonist, salmeterol, plus an inhaled corticosteroid (ICS) compared with an ICS alone.

Studies selected included all trials with treatments comparing salmeterol (S) + ICS (administered as FP/salmeterol via Diskus or concomitant ICS plus salmeterol) with ICS alone. A total of 9,954 subjects, aged 4 years and older, representing 2,859 patient years of exposure were included.

The investigators concluded that the use of salmeterol with an ICS compared with ICS alone resulted in fewer asthma exacerbations and asthma-related hospitalizations.