Background: Randomized controlled trials have demonstrated the efficacy of montelukast for treating asthma; whether this can be extrapolated to clinical effectiveness in routine practice has yet to be established.
Objective: To examine the use, effectiveness, and tolerability of montelukast in clinical practice for treating asthma and to explore prognostic factors that could predict a favorable response to the drug.
Methods: This was a retrospective, cross-sectional, observational study of clinical outcomes seen in patients prescribed montelukast for asthma that used routinely collected clinical information. Data were collected on all consenting patients who had been prescribed montelukast for asthma irrespective of the continuation or duration of treatment. Independent observers, treating physicians, and patients assessed certain outcomes after the initiation of montelukast, including the general asthma response and changes in activity-related symptoms.
Results: Fifty-six centers in the United Kingdom (20 primary care and 36 secondary care) participated. The analysis was based on 1351 eligible patients for whom essential data were available. Eight hundred thirty patients (66.4%; 95% CI, 63.8% to 69.0%) were recorded as having shown an improvement in their asthma control, and 103 (8.2%; 95% CI, 6.8% to 9.9%) experienced a dramatic improvement. The greatest proportion of patients responding was seen in those with mild to moderate asthma. Montelukast was well tolerated; no new adverse events were recorded.
Conclusions: Montelukast is an effective, well-tolerated treatment for asthma in routine practice. The overall response rate and tolerability seen in this survey are similar to those reported in randomized clinical trials.