Montelukast: new preparation. No current use in asthma.

(1) Montelukast, an antiasthmatic drug belonging to the leukotriene antagonist family, has two indications in France: as adjunctive treatment for mild to moderate chronic asthma when regular inhaled steroid therapy and short-acting inhaled beta 2 stimulants "on demand" are inadequate; and in the prevention of effort-induced asthma. (2) The clinical file on montelukast contains no methodologically acceptable comparisons with reference treatments. (3) Several placebo-controlled trials have shown the efficacy of montelukast, with an improvement in clinical scores and respiratory function tests in chronic asthma; and prevention of effort-induced asthma. (4) In chronic asthma montelukast has not been compared with oral or inhaled long-acting beta 2 stimulants, or with sustained-release theophylline in patients inadequately controlled by steroid therapy. (5) In effort-induced asthma, only two trials have compared montelukast to salmeterol. On the basis of preliminary results the authors concluded that montelukast was superior in both studies. (6) Clinical trials showed no clear difference in the frequency of side effects in patients on montelukast and those on a placebo. However, montelukast may possibly be associated with the Churg and Strauss syndrome in rare cases. (7) Montelukast is an expensive drug.