Safety of Adding Salmeterol to Fluticasone Propionate in Children with Asthma: no increase in risk

Long-acting beta-agonists (LABAs) have been shown to increase the risk of asthma-related hospitalization among children. This large study shows that the concomitant use of inhaled glucocorticoids with LABAs (ICS/LABA) mitigates those risks. The study was mandated by the Food and Drug Administration (FDA).

6,200 children, 4 to 11 years of age, who required daily asthma medications and had a history of asthma exacerbations in the previous year were randomized to receive fluticasone propionate plus salmeterol or fluticasone alone for 26 weeks.

Salmeterol in a fixed-dose combination with fluticasone was associated with the risk of a serious asthma-related event that was similar to the risk with fluticasone alone.

References:

Safety of Adding Salmeterol to Fluticasone Propionate in Children with Asthma. David A. Stempel. N Engl J Med 2016; 375:840-849, September 1, 2016.
http://www.nejm.org/doi/full/10.1056/NEJMoa1606356

The World Allergy Organization (WAO) Small Airways Working Group publishes a monthly "What's New?" summary and I have served as its editor since 2011. The summary features the top 3 asthma/small airways articles each month. The article above is a part of the project. The archive is here: http://www.worldallergy.org/small_airways_group/reviews/archive.php

Image source: Image source: FDA and Wikipedia, public domain.

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