Clinical Pharmacy News summary

Montelukast improves asthma control in children but results for adults remain inconclusive

Results of a study suggest that the leukotriene receptor antagonist montelukast (Singulair) can improve asthma control in children. However, two other trials on the drug, which involved adults with asthma poorly controlled by regular inhaled corticosteroid therapy, have given conflicting results.

The trial in children, which was conducted by Dr Estelle Simons from the department of paediatrics and child health at the University of Manitoba, Canada, and colleagues, involved 261 subjects aged six to 14 years, who had persistent asthma and were taking inhaled budesonide regularly.

The aim was to measure the change in forced expiratory volume in one second (FEV₁) achieved by adding montelukast 5mg daily to budesonide therapy for four weeks, compared with that achieved when placebo was added for four weeks.

The mean per cent increase in FEV₁ during montelukast treatment was 4.6 per cent compared with a 3.3 per cent rise seen with placebo (ie, a difference of 1.3 per cent, 95 per cent confidence interval –0.1 to 2.7, P=0.062). The researchers say: “Montelukast provides significant added benefits when administered concurrently with budesonide to children.”

The results appear in the Journal of Pediatrics (2001;138:694).

Trials in adult subjects

The first of the studies that involved adults was an analysis of seven trials (n=2,771) that compared the effects of taking at least 10mg montelukast daily with those of placebo.

Dr Neil Barnes from the London Chest Hospital and colleagues found that the FEV₁ of patients who received montelukast increased, on average, by a greater amount than it did in the placebo group.

“The pooled results show substantial positive treatment effects of montelukast, compared with placebo,” the authors say (Respiratory Medicine 2001;95:379).

The second study was a four-week trial that involved 72 adults with moderate or severe asthma who received either active treatment with montelukast for two weeks, followed by placebo, or the reverse.

Dr Douglas Robinson from the National Heart and Lung Institute in London and colleagues found that adding montelukast to the patients’ regular treatment did not result in significant changes to symptom scores. “We report no significant improvements in symptoms or lung function in patients treated with montelukast, and no suggestion of a subgroup of responding patients. Defining individual responses on the basis of improved peak flow showed equal response rates to active and placebo treatment,” they say (Lancet 2001;357:2007).

The United Kingdom Medicines Information Pharmacists Group produced an evaluation of montelukast this month (see its webpage). Other product evaluations issued by the group in June were for the antihistamine desloratidine (Neoclarityn) and the antibiotic linezolid (Zyvox).

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