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.

International Union of Basic and Clinical Pharmacology. LXXXIV: Leukotriene Receptor Nomenclature, Distribution, and Pathophysiological Functions

“…Results from meta-analyses indicate that antihistamines and LTRAs are equally effective in improving symptoms of AR and QL, but that both drugs are less effective than intranasal corticosteroids (Pullerits et al, 2002;Saengpanich et al, 2003;Di Lorenzo et al, 2004b;Wilson et al, 2004;Rodrigo and Yañ ez, 2006;Van Hoecke et al, 2007). However, in a retrospective observational study, addition of montelukast to current corticosteroid therapy improved long-term asthma control and resulted in substantial reductions in asthma-related resource use by patients with mild or moderate persistent asthma and concomitant seasonal AR (Borderias et al, 2007), confirming previous results on the efficacy of montelukast in patients with AR and asthma (Nayak, 2004;Philip et al, 2004;Price et al, 2006;Virchow and Bachert, 2006;Storms, 2007). Of interest, systemic medication such as montelukast, as expected, provided better relief for symptoms distant from the nasal cavity, whereas the antihistamine reduced rhinorrhea more than either montelukast or budesonide (Sardana et al, 2010).…”

Montelukast: Pharmacology, Safety, Tolerability and Efficacy

“…26 In a large phase IV study, 14 of 6158 patients (0.23%) reported 21 drug related adverse events consistent with the events noted above. 28 Isolated reports of Churg-Strauss syndrome (CSS), a rare systemic vasculitis asssociated with asthma, have been described in asthma patients treated with montelukast. 29,30 CSS is a rare necrotizing vasculitis with an annual prevalence of approximately 60 per million in asthma patients and 2-7 per million in the general population.…”

Effects of leukotriene D4 nasal challenge on bronchial responsiveness and inflammation in asthmatic patients with allergic rhinitis

“…Moreover, it has also been proven that LTD 4 effectively elicited bronchospasm in asthmatic patients in an attempt to identify leukotriene responsiveness subtypes (22,23). AR and asthma is a continuum of the inflammation involving one common airway (2), and the patients with coexisting AR and asthma might be the ideal candidates for initiating anti-leukotriene therapy (24,25). LTD 4 nasal provocation tests were safe for asthmatics, because LTD 4 would mostly be deposited in the upper airways when properly performed.…”