1. The rate of adverse asthma-related events was similar in patients with asthma treated with fixed-dosed salmeterol-fluticasone therapy compared to fluticasone monotherapy.
2. The mean percentage of rescue therapy-free days was similar in patients with asthma that were treated with fixed-dosed salmeterol-fluticasone therapy compared to fluticasone monotherapy.
Evidence Rating Level: 1 (Excellent)
Study Rundown: In adults, long-acting beta-agonists (LABAs) have been associated with an increased risk of asthma-related death. However, recent data on adolescents has demonstrated that LABA usage in a fixed-dose combination with an inhaled glucocorticoid does not increase the risk of adverse asthma-related events compared to inhaled glucocorticoid monotherapy. Additionally, recent meta-analyses have shown that combined LABA and inhaled glucocorticoid usage in pediatric patients reduced the risk of hospitalization. In this study, researchers aimed to prospectively determine whether fluticasone-salmeterol was superior to fluticasone alone with regards to adverse asthma-related events (i.e. hospitalization, intubation, death). Their results demonstrated that the rate of adverse asthma-related events was similar in patients treated with salmeterol-fluticasone and fluticasone only. Their data also showed that the mean percentage of rescue therapy-free days was similar in patients receiving fluticasone-salmeterol and fluticasone only. Their study is limited by its short duration of 6 months and the relatively infrequent occurrence of adverse asthma-related events.
In-Depth [randomized controlled trial]: In this randomized, double-blind, active-comparator trial, children between the ages of 4-11 years of age (n = 6208) were randomized to receive either fluticasone-salmeterol therapy (n = 3107) or fluticasone monotherapy (n = 3101) for 26 weeks. The primary outcome was first adverse asthma-related event (i.e. death, intubation, hospitalization). Of the 6208 patients, 27 (0.9%) in the fluticasone-salmeterol group and 21 (0.7%) met the composite safety end point, with a HR 1.28 (95%CI 0.72-2.27; p=0.006). All adverse asthma-related events were hospitalizations – there were no asthma-related deaths or intubations. In the fluticasone-salmeterol and fluticasone only group, 265 (8.5%) and 309 (10%) patients had one or more severe asthma exacerbations, respectively, with a HR 0.86 (95%CI 0.73-1.01). In a subgroup analysis, the number of patients who had a severe asthma exacerbation was 25% lower in patients who continued on combination therapy compared to those who had LABA withdrawn (7.5% vs. 9.9%; HR 0.75; 95%CI 0.57-0.98). The mean percentage of rescue therapy-free days was 83% and 81.9% in the salmeterol-fluticasone and fluticasone only groups. Additionally, the mean percentage of days with controlled asthma was also similar – with 74.7% in the combination therapy group and 73.4% in the fluticasone monotherapy group.
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