Level 2: Mid-level evidence

Long-acting beta agonists (LABAs) were associated with increased risk of asthma-related death, intubation, and hospitalization in a recent meta-analysis of individual patient data conducted by the FDA (FDA Statistical Briefing Package for Advisory Committee Meeting. December 10-11, 2008). The meta-analysisincluded 110 randomized trials of formoterol, formoterol/budesonide, salmeterol, and salmeterol/fluticasone. Composite of asthma-related death, intubation, or hospitalization occurred in 1.26% of patients with LABAs vs. 0.99% with comparator (P <.05, NNH 357). Methodologic limitations to the meta-analysis included incomplete data on dropouts, post-hoc analyses of adverse events, and limited data on concomitant inhaled corticosteroid use.