Do LABAs given with glucocorticoids increase severe asthma events?

November 1, 2016

Results of a randomized trial in children with asthma comparing concomitant use of the inhaled glucocorticoid fluticasone propionate plus the long-acting beta-agonist (LABA) salmeterol with use of fluticasone alone indicate that the answer to this question is “no.”

Results of a randomized trial in children with asthma comparing concomitant use of the inhaled glucocorticoid fluticasone propionate plus the long-acting beta-agonist (LABA) salmeterol with use of fluticasone alone indicate that the answer to this question is “no.”

The international trial was conducted in 6208 children aged from 4 to 11 years who required daily asthma medications and had a history of asthma exacerbations in the previous year. Participants were equally divided between fluticasone-salmeterol and fluticasone-alone groups; each group received treatment twice a day, according to 1 of 2 different fixed doses.

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At the end of the 26-week trial, investigators determined that the risk of a serious asthma-related event, requiring hospitalization, was similar in the 2 groups. Specifically, 27 children in the fluticasone-salmeterol group and 21 in the fluticasone-alone group had such an event. Similarly, 265 patients (8.5%) in the fluticasone-salmeterol group and 309 (10%) in the fluticasone-alone group had a severe asthma exacerbation. The risk of serious adverse events also was similar in the 2 groups; 1.8% and 1.7% of patients in the fluticasone-salmeterol group and the fluticasone-alone group, respectively, experienced them (Stempel DA, et al. N Engl J Med. 2016;375[9]:840-849).

Commentary

This large, carefully done study, mandated by the US Food and Drug Administration, offers helpful, reassuring information on the use of LABA in combination with inhaled steroids in children. However, the study does not justify use of this combination as first-line therapy for children with asthma, nor does it justify hasty movement toward combination therapy in a child whose asthma is poorly controlled on inhaled steroids alone. Instead, as stated in an accompanying editorial, in poorly controlled asthma, “pediatricians are advised to first check the adequacy of technique with the medication-delivery device, make sure that patients and children understand treatment and action plans, and at a minimum, verify whether the family is collecting enough prescriptions to cover the need for regular medications” (Bush A, et al. N Engl J Med. 2016;375[9]:889-891). -Michael G Burke, MD 

Ms Freedman is a freelance medical editor and writer in New Jersey. Dr Burke, section editor for Journal Club, is chairman of the Department of Pediatrics at Saint Agnes Hospital, Baltimore, Maryland. The editors have nothing to disclose in regard to affiliations with or financial interests in any organizations that may have an interest in any part of this article.