ירחון החברה הישראלית לפדיאטריה אמבולטורית (חיפ"א) גיליון 2018-1

7 Salmeterol, a long-acting Beta-agonist (LABA), when used in conjunction with fluticasone, does not increase risk asthma morbidity. Salmeterol (Long-acting Beta-agonist) is available in Israel as Serevent (Salmeteraol alone) or as Sertide (Salmeteraol + Fluticasone). Studies have called into question the safety of using salmeterol alone. In this study, Stempel, et al 1 , investigated if salmeterol increases asthma morbidity when used with fluticasone, conducting a randomized trial with over 6,000 participants from 32 different countries. Children with persistent asthma, aged 4-11, were given fluticasone with or without salmeterol and at 2 different doses. The patients in the combination therapy group and the fluticasone alone group had similar rates of asthma exacerbation and there were no cases of intubation or sudden death. Whereas this study is reassuring, the rate of asthma exacerbation in all groups was low (<1% hospitalization for each group) and it did not include severe asthmatics. Patients who withdrew from LABA use had relatively increased incidence of exacerbations. One more in a serious of large studies concerning the safety of LABA, this study provides valuable support for salmeterol use, but concerns persist. For sure, more studies will follow 2,3 . Bottom line: Salmeterol can be used in conjunction with fluticasone. 1. 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 2. Yoshihara S, et al. Efficacy and Safety of Salmeterol/fluticasone Combination Therapy in Infants and Preschool Children with Asthma Insufficiently Controlled by Inhaled Corticosteroids. Drug Res (Stuttg). 2016 Jul;66(7):371-6. 3. Mansfield L, et al. A 6-month safety and efficacy study of fluticasone propionate and fluticasonepropionate/salmeterol multidose dry powder inhalers in persistent asthma. Allergy Asthma Proc. 2017 Jul 24;38(4):264-276.