title: Efficacy and safety of montelukast in adults with asthma and allergic rhinitis.
abstract: Several clinical studies have confirmed the effectiveness of montelukast 10mg orally in adults with both asthma and allergic rhinitis. The objective of this phase IV study was to investigate the efficacy and safety of montelukast 10mg in adults with both asthma and allergic rhinitis in a real-life setting. Data from 5855 patients (mean age: 42.8+/-15.4 years) were collected and analyzed following treatment for 4-6 weeks. Efficacy was analyzed by comparing baseline values of: general, day- and night-time improvement in asthma symptoms, need for rescue medication or inhaled corticosteroids (ICSs), general and specific improvement in allergic rhinitis symptoms, reduction in rhinitis medication use, and general and specific quality of life (QoL) improvement with values collected at the end of the observation period of 4-6 weeks. Following treatment with 10mg montelukast 86.5% (n=4547) of patients reported a strong or marked improvement in day-time asthma symptoms and 88.5% (n=4367) reported improvement in night-time symptoms. A similarly high proportion of patients had a strong or marked improvement in all symptoms of allergic rhinitis (i.e. sneezing/itching (84%), rhinorrhea (81.7%), nasal congestion (79.3%), watery eyes (78.4%) and red or burning eyes (77.7%). The use of asthma and rhinitis medication was also reduced. 92.3% (n=5685) of all patients intended to continue montelukast therapy. Overall QoL was "very good" or "good" in 85.2% of patients (n=4991) and a "strong" or "marked" improvement in each of the four domains of sleep, work, everyday life and physical activity. Montelukast was well tolerated. Adverse drug reactions occurred in 14 out of 6158 patients. None of the adverse events was serious. Accordingly, montelukast 10mg is a safe and effective treatment for patients with both asthma and allergic rhinitis.
authors.affiliation: Universität Rostock, Ernst-Heydemann-Str. 6, 18057 Rostock, Germany. j.c.virchow@med.uni-rostock.de
authors.forename: J Chr
authors.initials: JC
authors.lastname: Virchow
authors.forename: C
authors.initials: C
authors.lastname: Bachert
mesh_terms: D000085:Acetates / Q000009:adverse effects / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy / Q000503:physiopathology; D003521:Cyclopropanes; D005260:Female; D006801:Humans; D020024:Leukotriene Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing / Q000379:methods; D011788:Quality of Life; D011804:Quinolines / Q000009:adverse effects / Q000627:therapeutic use*; D012130:Respiratory Hypersensitivity / Q000188:drug therapy* / Q000503:physiopathology; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy / Q000503:physiopathology; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy / Q000503:physiopathology; D013440:Sulfides; D016896:Treatment Outcome
chemical_list: D000085:Acetates; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; C093875:montelukast