What evidence supports the use of Montelukast (Singulair) for asthma management?

From the Guidelines

Montelukast is a recommended medication for the management of mild persistent asthma, particularly for patients who are unable or unwilling to use inhaled corticosteroids, as supported by the study published in the American Family Physician in 2010 1. The use of montelukast as an alternative therapy for mild persistent asthma is based on its ability to block inflammatory mediators that contribute to asthma symptoms.

• The standard dosage for adults and adolescents 15 years and older is 10mg once daily, typically taken in the evening.
• For children 6-14 years old, the recommended dose is 5mg once daily, while children 2-5 years old should receive 4mg once daily in the form of chewable tablets or oral granules. Montelukast is particularly useful for patients with exercise-induced bronchoconstriction, aspirin-sensitive asthma, or those with concurrent allergic rhinitis.
• It can be used as an add-on therapy to inhaled corticosteroids or as monotherapy in mild persistent asthma.
• Patients should be aware that while montelukast helps prevent asthma symptoms, it is not intended for treating acute asthma attacks. Some patients may experience side effects including headache, gastrointestinal disturbances, and rarely, neuropsychiatric events such as mood changes or behavior disturbances, as noted in the guidelines published in the Journal of Allergy and Clinical Immunology in 2007 1. Regular follow-up with healthcare providers is recommended to assess treatment effectiveness and monitor for potential side effects.
• The study published in the Journal of Allergy and Clinical Immunology in 2002 1 also highlights the importance of considering the addition of other long-term-control medications to inhaled corticosteroids in the management of asthma.

From the FDA Drug Label

Montelukast causes inhibition of airway cysteinyl leukotriene receptors as demonstrated by the ability to inhibit bronchoconstriction due to inhaled LTD4 in asthmatics. The efficacy of SINGULAIR for the chronic treatment of asthma in adults and adolescents 15 years of age and older was demonstrated in two (U. S. and Multinational) similarly designed, randomized, 12-week, double-blind, placebo-controlled trials in 1576 patients (795 treated with SINGULAIR, 530 treated with placebo, and 251 treated with active control). In adult patients, SINGULAIR reduced “as-needed” β-agonist use by 26.1% from baseline compared with 4. 6% for placebo. SINGULAIR, compared with placebo, significantly improved other protocol-defined, asthma-related outcome measurements.

The use of montelukast is supported for asthma treatment, as it has been shown to:

• Inhibit airway cysteinyl leukotriene receptors
• Reduce "as-needed" β-agonist use
• Improve asthma-related outcome measurements This is based on clinical trials in adults and adolescents 15 years of age and older, as reported in 2 and 2.

From the Research

Montelukast for Asthma Treatment

• Montelukast has been shown to be effective in improving asthma control and quality of life in patients with mild to moderate persistent asthma 3.
• As an add-on therapy to inhaled corticosteroids, montelukast can reduce the need for inhaled steroids while maintaining asthma control 4.
• Montelukast has also been found to be effective in reducing asthma exacerbations in adults with chronic asthma, with a significant reduction in the number of exacerbations compared to placebo 5.
• In patients with asthma and concurrent allergic rhinitis, montelukast add-on therapy has been shown to be effective in managing both asthma and allergic rhinitis symptoms 6.

Key Findings

• Montelukast monotherapy can improve quality of life and asthma control in patients with mild to moderate persistent asthma 3.
• Montelukast add-on therapy can reduce the need for inhaled corticosteroids while maintaining asthma control 4.
• Montelukast can reduce asthma exacerbations in adults with chronic asthma, but has inferior efficacy to inhaled corticosteroids or inhaled corticosteroids plus long-acting beta-agonists 5.
• Montelukast add-on therapy can improve asthma control and reduce allergic rhinitis symptoms in patients with asthma and concurrent allergic rhinitis 6.

Study Results

• A study published in Cureus found that montelukast monotherapy improved quality of life and asthma control in patients with mild to moderate persistent asthma 3.
• A study published in Clinical and Experimental Allergy found that montelukast add-on therapy reduced the need for inhaled corticosteroids while maintaining asthma control 4.
• A meta-analysis published in Allergy and Asthma Proceedings found that montelukast reduced asthma exacerbations in adults with chronic asthma, but had inferior efficacy to inhaled corticosteroids or inhaled corticosteroids plus long-acting beta-agonists 5.
• A study published in Canadian Respiratory Journal found that montelukast add-on therapy improved asthma control and reduced allergic rhinitis symptoms in patients with asthma and concurrent allergic rhinitis 6.