Real-life effectiveness of Singulair® (Montelukast) in 506 children with mild to moderate asthma

Background: Based on the outcome of several randomized controlled trials, the orally active leukotriene receptor antagonist montelukast (Singulair®, Merck) has been licensed for treatment of asthma. The drug is favored for treating childhood asthma, where a therapeutic challenge has arisen due to poor compliance with inhalation therapy. Objectives: To assess the efficiency of and satisfaction with Singulair® in asthmatic children under real-life conditions. Methods: Montelukast was prescribed for 6 weeks to a cohort of 506 children aged 2 to 18 years with mild to moderate persistent asthma, who were enrolled by 200 primary care pediatricians countrywide. Four clinical correlates of childhood asthma - wheeze, cough, difficulty in breathing, night awakening - were evaluated from patients' diary cards. Results: Due to under-treatment by their physicians, almost 60% of the children were not receiving controller therapy at baseline. By the end of the study, which consisted of montelukast treatment, a significant improvement over baseline was noted in asthma symptoms anf severity, as well as in treatment compliance. The participating pediatricians and parents were highly satisfied with the treatment. Conclusions: The results of this extensive study show that the use of montelukast as monotherapy in children presenting with persistent asthma resulted in a highly satisfactory outcome for themselves, their parents and their physicians.