Abstract:

Montelukast is a selective antagonist of the leukotriene D (LTD) receptor. In patients with asthma, montelukast 5 to 250 mg/day attenuated LTD-induced bronchoconstriction and, at a dosage of 10mg, significantly reduced early and late airway response to allergen (dust mite extract) relative to placebo.

In studies evaluating the effects of various dosages of montelukast on exercise-induced bronchoconstriction the optimal dose of the drug was found to be 10mg.

Montelukast 10 mg/day controlled asthma significantly more effectively than placebo in a 3-month randomised double-blind study. In a 9-month open extension of this trial, during which patients were randomised to treatment with montelukast 10 mg/day or beclomethasone (400 µg/day), daytime symptom score and -agonist use decreased to a similar extent in each group.

In a further study, treatment with montelukast 10 mg/day permitted clinically significant tapering of corticosteroid dosage in patients with stable asthma.

Montelukast (5 mg/day) has also demonstrated efficacy in childhood asthma.

The tolerability profile of montelukast was similar to that of placebo in placebo-controlled clinical trials in adults and children; the most common adverse event was headache.

Keywords: Reviews-on-treatment; Montelukast, general; Asthma, treatment; New-drug-profiles; Montelukast, pharmacodynamics; Montelukast, therapeutic-use; Montelukast, pharmacokinetics; Montelukast, drug-interactions; Drug-interactions; Clinical-pharmacokinetics; Montelukast, adverse-reactions; Leukotriene-antagonists, general; Bioavailability

Language: English

Document Type: New drug profile

Affiliations: 1: Adis International Limited, Auckland, New Zealand *