SOURCE: Stempel DA, Raphiou IH, Kral KM, et al. Serious asthma events with fluticasone plus salmeterol versus fluticasone alone. N Engl J Med 2016;374:1822-1830.
Monotherapy with salmeterol or other long-acting beta agonists (LABA) is not recommended for asthma treatment, based on the observation in asthma clinical trials that salmeterol monotherapy is associated with increased mortality. Similarly, a meta-analysis of patients who received combination treatment with salmeterol and fluticasone provided in separate inhalers also showed higher asthma-related hospitalizations and death. However, it did not go unnoticed that just because patients received prescriptions for separate salmeterol and fluticasone inhalers does not guarantee that they actually used both devices, hence allowing for the possibility that some patients assigned dual treatment actually were only receiving LABA (or fluticasone) monotherapy.
To better address FDA concerns about LABA safety, researchers performed a randomized, double-blind trial comparing LABA + fluticasone (within the same inhalation device) to fluticasone monotherapy (n = 11,679). The primary endpoint was serious asthma-related events (death, intubation, hospitalization) over 26 weeks.
There was no difference in serious asthma-related events between LABA + fluticasone and fluticasone monotherapy. However, asthma exacerbations were 21% lower in the combination LABA + fluticasone treatment group.
The prescription of LABA monotherapy for asthma patients is still appropriate, but data are reassuring in regard to LABA + fluticasone therapy through which many patients enjoy symptom control and reduced exacerbations.