Sidorenko I.V., Zahargevskaya T.V. Efficacy and safety of montelukast in patients with asthma and allergic rhinitis in routine clinical practice: results of a prospective multicenter observational program

· RAJ №2-2016

Sidorenko I.V., Zahargevskaya T.V.

Department of Clinical Immunology and Allergology, I.M. Sechenov First Moscow State Medical
University, Moscow, Russia

Key words: asthma, allergic rhinitis, cysteinyl leukotrienes, montelukast, prospective multicenter
observational program

Background. To evaluate efficacy and safety of montelukast in the treatment of adult patients with asthma,
allergic rhinitis or with combination of asthma and allergic rhinitis in routine clinical practice.
Methods. The open-label, single-arm, prospective, multicenter observational program. No specific procedures
beyond routine clinical practice were performed. Data collection was performed at baseline (at the enrollment
in the program) as well as after the end of the prescribed course of treatment with montelukast Actavis, but not
more than at 12 weeks of treatment. The study included 545 patients. Criteria for efficacy: the frequency of the
daytime and nocturnal symptoms of asthma needs the rescue medications, the number of exacerbations during
the last 3 months (hospitalizations, calls for specialized medical care), change of the nasal symptoms score (TNSS).
Results. After 12 weeks of therapy, the proportion of patients who maintained daily asthma symptoms, decreased
by 3,4 times and amounted to only 22% compared to 75,2% at baseline. Especially significant, 4,3-fold, reduced
the number of patients with nocturnal symptoms – from 61,8% to 14,4%. The need to use drugs emergency and
restriction of activities associated with asthma symptoms also decreased by 3,6 and 3,2 times, respectively.
Conclusion. The use of montelukast Actavis in patients with asthma, AR and a combination of asthma and AR is
efficient, safe, and helps to improve the control of asthma symptoms and the AR; the improvement of the general
condition of patients, as well as reduction of the percentage of eosinophils in the blood was shown. The drug is
well tolerated and is convenient for patients.