A trial revealed that combination treatment with salmeterol and fluticasone in a single inhaler did not lead to adverse events and was linked to fewer asthma exacerbations.
In highly-adherent pediatric and adult asthma patients enrolled in the multicenter, double-blind trial, the hazard ratio for a serious asthma-related event in the fluticasone-salmeterol (Advair Diskus) group was 1.03 (95% CI 0.64-1.66, P=0.003) and no asthma-related deaths occurred, reported David A. Stempel, MD, of GlaxoSmithKline (GSK) in Durham, NC, and colleagues.
The risk for severe asthma exacerbations was found to be 21% lower in the fluticasone-salmeterol group than in the fluticasone-alone group (HR 0.79, 95% CI 0.70-0.89), with severe asthma exacerbations occurring in 8% of the combination-treatment group and 10% of the glucocorticosteroid-alone group (P<0.001), they wrote in the New England Journal of Medicine.
The results were presented simultaneously at the American Academy of Allergy Asthma & Immunology annual meeting.
GSK conducted the study at the request of the FDA, which asked all manufacturers of combo LABA plus inhaled steroid treatments to examine the safety of their products following the publication of the Serevent Nationwide Surveillance (SNS) and SMART trials, both of which appeared to link their use to an increased risk of asthma-related death.