2006 OPEN FORUM Abstracts
PHARMACOECONOMIC OUTCOMES OF LEVALBUTEROL AND RACEMIC ALBUTEROL IN INPATIENTS REQUIRING NEBULIZATION (POLARIS)
J. F. Donohue MD1, N.A. Hanania MD2,
R.L. Ciubotaru MD,3 N. Barry RN4, R. Claus MS4,
and W.T. Andrews, MD4. 1 University of North Carolina
at Chapel Hill School of Medicine, Chapel Hill, NC, 2 Baylor College of Medicine,
Houston, TX, 3 Cornell
University Medical School, New York, NY, 4 Sepracor Inc.,
PURPOSE: Several studies have suggested that treatment of bronchospasm with levalbuterol may result 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 (n=263) or COPD (n=215) to evaluate the relative cost-effectiveness of the two treatments.
Methods: Patients were randomly assigned to treatment with levalbuterol 1.25 mg Q8h (N=241) or racemic albuterol 2.5 mg, administered per routine standing hospital order, usually Q4-6h (N=238). Rescue treatments with matching beta-agonist were provided. The primary efficacy endpoint was the total number of nebulizations during hospital stay among all patients, and 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 1-100) derived from a general health assessment question. These data were also stratified by disease.
Results: Upon admission to the hospital, patients randomized to receive levalbuterol required significantly fewer total nebulizations (median 10 vs 12; p=0.031) and scheduled nebulizations (median 9 vs 11; p=0.009) compared with racemic albuterol. No significant differences in the number of rescue nebulizations, median length of hospital stay, median time to discharge, or total hospital costs 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. The overall findings were not appreciably different when analyzed by disease. Asthma and COPD patients receiving levalbuterol compared with racemic albuterol required fewer total nebulizations (median 8 vs 10; p=0.12 and 12 vs 16; p=0.15, respectively) and scheduled nebulizations (median 7 vs 9; p=0.058 and 11 vs 16; p=0.073; respectively). In addition, stratifying by disease did not demonstrate significant differences in other parameters such as number of rescue nebulizations and total hospital costs.
Conclusions: In this study, patients treated with levalbuterol required significantly fewer total and scheduled nebulizations without an increased need for rescue nebulizations. Moreover, cost-effective analysis indicated that levalbuterol was cost effective when compared with racemic albuterol.
Support for this study provided by Sepracor Inc.