RATIONALE: To conduct a meta-analysis of observational studies comparing the frequency of asthma exacerbations in pediatric patients receiving fluticasone propionate/salmeterol in a fixed-dose combination (FSC) versus inhaled corticosteroids (ICS) or ICS plus montelukast (MON).
METHODS: Systematic literature review (including any unpublished GSK studies) and published observational studies. Observational studies that addressed differences in baseline risk for asthma exacerbations, reported outcomes in pediatric patients, reported an adjusted odds ratio (OR) or hazard ratio (HR) of asthma-related hospitalizations and/or emergency department (ED) visits, or where an unadjusted OR could be calculated were included.
RESULTS: 350 articles from Embase and Medline met search criteria. Additionally, 7 unpublished studies were identified from GSK’s research registry. Of the 357 articles, 92 were identified as potentially relevant. Of these, 86 were excluded due to inappropriate study design (n540), treatments (n520), populations (n516), outcomes (n58), duplicate reporting (n51), or were non-observational (n51). Thus, 6 retrospective analyses using US medical and pharmacy claims databases, with approximately 46,000 subjects were included. The meta-analysis demonstrated FSC was associated with a significantly lower risk of IP/ED visits (OR50.91; 95% CI: 0.86, 0.97) compared with ICS alone, and (OR50.46; 95% CI: 0.27, 0.76) compared with ICS+MON. Sensitivity analyses to explore heterogeneity were conducted on patient characteristics, but did not meaningfully alter the overall magnitude of effects.
CONCLUSIONS: This meta-analysis revealed that pediatrics patients receiving FSC experienced significantly fewer serious exacerbations than those using ICS alone or ICS plus MON.
