Background
Leukotriene receptor antagonists (LTRAs) are recommended as alternative treatment in patients with mild asthma, but their effect compared with placebo is unclear.
Purpose
To determine the benefits and harms of LTRAs as monotherapy or in combination with inhaled corticosteroids compared with placebo in adults and adolescents with asthma.
Data sources
MEDLINE and the Cochrane Central Register of Controlled Trials from inception through June 2015.
Study selection
Peer-reviewed, English-language, randomized controlled trials in patients with asthma that reported the effect of LTRAs versus placebo on measures of asthma control.
Data extraction
Three researchers extracted data on the study population, interventions, outcome measures, adverse events, and study methodology were extracted in duplicate.
Data synthesis
Of 2008 abstracts screened, 50 trials met eligibility criteria. Random-effects meta-analyses and meta-regression were performed. In six trials of LTRA monotherapy, LTRAs reduced the risk of an exacerbation (summary risk ratio [RR] = 0.60, 95% CI 0.44, 0.81). In four trials of LTRA as an add-on to inhaled corticosteroids, the summary RR for exacerbation was 0.80 (95% CI: 0.60, 1.07). LTRAs significantly increased FEV1 either as monotherapy or as add-on to inhaled corticosteroids, whereas FEV1 % predicted was only improved in trials of LTRA monotherapy. Adverse event rates were similar in the intervention and comparator groups.
Limitations
Variation in definitions and reporting of outcomes, high risk of bias, heterogeneity, and possible selective outcome reporting bias.
Conclusions
LTRAs as monotherapy improved asthma control compared to placebo. It remains unclear however, which patients with asthma are more likely to respond to treatment with LTRAs.