PURPOSE: Previous studies demonstrated that treatment of bronchospasm with levalbuterol resulted in significantly fewer nebulizer treatments and/or decreased total cost of care vs treatment with racemic albuterol. This study utilized a multicenter, randomized, prospective, open-label design in patients hospitalized for acute asthma or COPD to evaluate these outcomes, and the relative cost-effectiveness of the two treatments.
METHODS: Upon admission to the hospital, patients were randomly assigned to treatment with levalbuterol 1.25 mg Q8h (N=241) or racemic albuterol, administered per routine standing hospital orders (usually Q4-6h; N=238). Standing orders with matching beta-agonist were provided for rescue treatments. The primary efficacy endpoint was the total number of nebulizations during hospital stay. Secondary endpoints included measures of pulmonary function and length and cost of hospital stay. Cost-effectiveness analyses were conducted using actual patient costs and an efficacy score (scale 0-100) derived from a general health assessment question.
RESULTS: Patients randomized to receive levalbuterol required significantly fewer total nebulizations (median 10 vs 12; p=0.031) and scheduled nebulizations compared with racemic albuterol (median 9 vs 11; p=0.009). No significant differences in the number of rescue nebulizations, median length of hospital stay, median time to discharge, or total hospital costs ($3,676 for levalbuterol vs $3,841 for racemic albuterol) were noted. The primary pharmacoeconomic analysis using Subject General Well-Being as the measure of efficacy showed use of levalbuterol was $165 less costly with an increase of ∼2 units in effectiveness compared with racemic albuterol. Results using Beta-Mediated Treatment Effects and Disease Symptom Assessments were consistent. Bootstrap re-sampling methodology showed levalbuterol to be cost-effective in approximately 67% of the 10,000 simulations.
CONCLUSION: Compared with racemic albuterol, levalbuterol resulted in administration of significantly fewer total and scheduled nebulizations without an increase in rescue nebulizations, supporting its use every 8 hours.
CLINICAL IMPLICATIONS: Levalbuterol 1.25mg Q8h in hospitalized patients with asthma or COPD reduced total and scheduled nebulizer treatments without increasing the cost of therapy and may be cost effective when compared with use of racemic albuterol.
DISCLOSURE: James Donohue, Consultant fee, speaker bureau, advisory committee, etc. Consultant and Advisor to Sepracor Inc.; Other Clinical Investigator for Sepracor Inc.