Spotlight on Montelukast in Asthma in Children 2 to 14 Years of Age
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ADIS SPOTLIGHT
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Spotlight on Montelukast in Asthma in Children 2 to 14 Years of Age1 Richard B. R. Muijsers and Stuart Noble Adis International Inc., Langhorne, Pennsylvania, USA
Contents Abstract . . . . . . . . . . . . . 1. Pharmacodynamic Profile . . . . 2. Pharmacokinetic Profile . . . . . 3. Therapeutic Use . . . . . . . . . . 3.1 Children aged 6 to 14 Years 3.2 Children Aged 2 to 5 Years . 4. Tolerability . . . . . . . . . . . . . 5. Dosage and Administration . . .
Abstract
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Montelukast is a cysteinyl leukotriene receptor antagonist which is used as a preventive treatment for persistent asthma in patients ≥2 years of age. In children aged 6 to 14 years montelukast (5 mg/day) treatment resulted in a significant increase in FEV1 (forced expiratory volume in 1 second, primary clinical outcome) during an 8-week randomized, double-blind trial. Moreover, significant improvements were observed for a range of secondary endpoints assessing symptoms, exacerbation rates, β-agonist usage and quality of life. Concomitant administration of montelukast (5 mg/day) and inhaled budesonide (200μg twice daily) resulted in a trend towards an increase in FEV1 (p = 0.06, primary endpoint) and a statistically significant reduction in both as-needed β2-agonist usage and the percentage of days with asthma exacerbations compared with budesonide plus placebo. No significant differences were observed in asthma-related quality of life between the two groups. During clinical trials both improvements in lung function and reductions in as-needed β2-agonist usage were generally observed within 1 day after initiation of therapy in children 2 to 14 years of age with persistent asthma. Data from a randomized, nonblind trial in 6- to 11-year-old children and a 6-month extension to this trial suggest that both compliance to therapy and patient satisfaction are greater for montelukast than for either inhaled cromolyn sodium (sodium cromoglycate) or inhaled beclomethasone. In addition, patients and parents preferred oral montelukast over cromolyn
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