Objective: To compare the efficacy of inhaled corticosteroids (ICS) vs. montelukast (MONT) in schoolchildren and adolescents with mild-moderate persistent asthma.
Methods: Randomized, prospective, controlled trials published January 1996-February 2009 with a minimum of 4 weeks of ICS vs. MONT and of ICS vs. MONT+ICS were retrieved through Medline, Embase and Central databases. Primary outcome was asthma exacerbations requiring systemic corticosteroids (AEX); secondary outcomes were pulmonary function, withdrawal/hospitalization due to AEX, change in symptoms score, rescue medication free days, albuterol use, adverse effects and adherence.
Results: Of 124 studies identified, 18 studies (n=3757 patients) met criteria for inclusion (13 compared ICS vs. MONT, 3 ICS vs. MONT+ICS and 2 ICS vs. MONT vs. ICS+MONT). Patients receiving ICS showed a significantly decreased risk for AEX than those with MONT (RR=0.83, 95% CI= 0.72-0.96, p=0.01); post-hoc analysis suggests this effect was independent of quality, sponsorship and study duration. Children treated with ICS had significant higher pulmonary function (final FEV1 % predicted, change from baseline FEV1 %, final morning PEF) and better clinical parameters (albuterol use, symptom score, rescue medication free days, withdrawals due to AEX) vs. MONT. No significant difference in primary or secondary outcomes was found when MONT was add-on to ICS vs. ICS alone; however these analyses were based in only two studies.
Conclusions: Schoolchildren and adolescents with mild-persistent asthma treated with ICS had less AEX and better lung function and asthma control than with MONT. There is insufficient data to determine if the addition of MONT to ICS improves outcome.