Observational study of the effects of using montelukast vs fluticasone in patients matched at baseline.

Background: The relative effectiveness of inhaled corticosteroids and leukotriene receptor antagonists in asthma therapy continues to be the subject of clinical studies. Recent studies have examined the impact of these therapies using a retrospective design. Retrospective studies require special attention to nonrandom assignment of participants to treatment groups and, consequently, to the need to appropriately account for baseline differences.

Objective: To examine the relative effectiveness of montelukast sodium vs fluticasone propionate as controller monotherapy in patients with asthma.

Methods: A retrospective cohort analysis of claims data from 6,160 individuals continuously enrolled in 1 of 20 US managed care plans. Patients using fluticasone were matched to those treated with montelukast using propensity scores and age (2-55 years). Health care use was determined for the 12-month periods before and after the initial controller prescription. Outcomes included asthma-related hospitalizations and emergency department visits, along with use of oral corticosteroids and short-acting beta-agonists. Logistic regression analyses were also performed.

Results: Overall, controller therapy significantly reduced the odds of postindex asthma-related hospitalizations (odds ratio, 0.56; 95% confidence interval, 0.38-0.79); no significant difference was observed with asthma-related emergency department visits (odds ratio, 0.89; 95% confidence interval, 0.76-1.04). Differences in the relative effect in the montelukast and fluticasone groups were not observed. Similarly, increases in the postindex rate of short-acting beta-agonist use and increases in oral corticosteroid use for both montelukast and fluticasone patients were noted.

Conclusions: Similar outcomes were observed in montelukast and fluticasone users in this matched cohort analysis.