MARLBOROUGH, Mass., Oct 23, 2006 (BUSINESS WIRE) -- Sepracor Inc. (SEPR, Trade) today announced the presentation of posters of clinical data from studies of XOPENEX HFA(R) (levalbuterol tartrate) Inhalation Aerosol and XOPENEX(R) (levalbuterol HCl) Inhalation Solution at CHEST 2006, the annual meeting of the American College of Chest Physicians (ACCP), in Salt Lake City.
Pharmacoeconomic Outcomes of Levalbuterol and Racemic Albuterol in Inpatients Requiring Nebulization (POLARIS)
Results of a randomized, prospective, open-label, multi-center study assessing clinical outcomes based on the number of nebulizations throughout the duration of the hospital stay and cost-effectiveness in hospitalized patients administered either XOPENEX Inhalation Solution (n=241) or racemic albuterol (n=238) by nebulization were presented. Upon admission to the hospital, patients were randomly assigned to treatment with XOPENEX 1.25 mg Q8h (every eight hours) or racemic albuterol administered per routine standing hospital orders, which was usually Q4-6h (every four to six hours). Standing orders with a matching beta-agonist were provided for rescue treatments.
In this study, patients administered XOPENEX Inhalation Solution received fewer total nebulizations during their hospital stay versus patients administered albuterol (median 10 for XOPENEX, 12 for albuterol; p=0.03). No significant differences were observed between the two groups in measures of FEV1, duration of hospital stay, relapse rate, total hospital costs or respiratory costs. The primary pharmacoeconomic analysis was based on costs and Subject General Well-Being (SGWB) and showed an increase of approximately 2 units in SGWB (scale 0-100) when compared with albuterol and that use of XOPENEX was $165 less costly per patient. The results of this study confirmed that less frequent administration of XOPENEX Inhalation Solution maintained comparable efficacy compared with albuterol without increasing the cost of therapy and may be cost effective when compared to use of albuterol. XOPENEX Inhalation Solution was generally well tolerated in this study.
Long-term Safety of Levalbuterol Administered via Metered-Dose Inhaler in Patients with Asthma |
