Safety of fluticasone-salmeterol combination therapy in asthma

In early studies, a small increase in asthma-related deaths associated with salmeterol led the US Food and Drug Administration to place a boxed warning on the use of salmeterol in asthma. While concerning, the number of events was small, and the magnitude of the risk was unclear. In addition, it could not be determined if the potential risk of salmeterol could be mitigated by combining it with an inhaled glucocorticoid. The safety of salmeterol in combination with fluticasone has been assessed in a multicenter trial, in which almost 12,000 adolescents and adults with persistent asthma were randomly assigned to take inhaled fluticasone or the combination of inhaled fluticasone-salmeterol (in a single inhaler) for 26 weeks [1]. The rate of serious asthma-related adverse events was similar in the two groups, and no deaths occurred in either group. In addition, no difference was noted in the rate of asthma-related hospitalizations. Thus, for patients over age 12 who do not have a history of life-threatening asthma events, data are reassuring about the safety of fluticasone-salmeterol in a fixed-dose inhaler.
1. Stempel DA, Raphiou IH, Kral KM, et al. Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone. N Engl J Med 2016.