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Results suggested improvement in several endpoints for Seretide/Advair Diskus compared to ICS alone
London, UK | June 10, 2008 | African American patients with asthma treated with Seretide/Advair Diskus, a combination of the long-acting beta-agonist (LABA), salmeterol, and the inhaled corticosteroid (ICS), fluticasone propionate, had a lower rate of exacerbations when compared with patients who received treatment with the ICS, Flovent Diskus(R) (fluticasone propionate inhalation powder) alone, although the difference was not statistically significant. Patients in the salmeterol/fluticasone propionate group also showed improvements in lung function measures, night-time awakenings due to asthma, and reductions in daily symptoms and rescue inhaler use compared to fluticasone propionate. The data was published in the June 2008 issue of Current Medical Research and Opinion.
This large prospective trial, which followed 475 patients who received either twice-daily salmeterol/fluticasone propionate 100/50 (inhalation powder) or twice-daily fluticasone propionate 100mcg for a year, was the first prospective study to assess the addition of a LABA to an ICS compared to ICS alone in African Americans with persistent asthma.
In this study, salmeterol/fluticasone propionate provided important benefits to patients and no increased rate of adverse events compared with fluticasone propionate in the African American patient population. The findings of the study also contribute to the body of evidence which has found that salmeterol (a LABA) is not associated with an increase in serious asthma-related events when used with an ICS, but rather provides clinical benefits for patients who require more than ICS treatment alone to control their asthma.
“Uncontrolled asthma is a critical public health issue for African Americans, and this research is reassuring for clinicians whose patients are not controlled on an ICS alone that treatment with salmeterol/fluticasone propionate helps improve day-to-day asthma control,” said William Bailey, M.D., lead author and Director of the Lung Health Center at the University of Alabama at Birmingham. “Preventing exacerbations and improving lung function are important goals of asthma management.”
Current treatment guidelines recommend the addition of a LABA to an ICS in patients with moderate to severe asthma who are uncontrolled on an ICS alone. Taken in combination, an ICS and LABA fight the two main components 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. Optimal therapy for many patients with persistent moderate to severe asthma requires treatment of both these components.
The study was designed to primarily show that salmeterol/fluticasone propionate improved the rate of exacerbations compared to fluticasone propionate. While salmeterol/fluticasone propionate patients had a lower exacerbation rate than those patients in the fluticasone propionate group, the difference was not statistically significant. On most of the secondary endpoints, patients given salmeterol/fluticasone propionate performed better than patients who used fluticasone propionate. Forced expiratory volume in one second (FEV1) improved in salmeterol/fluticasone propionate patients. Both morning and evening peak expiratory flow (PEF) were also improved in the salmeterol/fluticasone propionate group. Patients using salmeterol/fluticasone propionate were also less likely to awaken at night due to asthma-related breathing difficulties. Additionally, the salmeterol/fluticasone propionate group showed reductions in the rate of daily symptoms and the need for a rescue inhaler.
Both salmeterol/fluticasone propionate and fluticasone propionate were well tolerated. Over a one-year period, the overall incidence of adverse events was similar between the two groups.
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SOURCE: GlaxoSmithKline |
