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.,
Marlborough, MA
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.