EFFICACY OF NEBULIZED ARFORMOTEROL FOR THE TREATMENT OF PATIENTS WITH COPD: A ROLE FOR LONG-ACTING BRONCHODILATORS IN TREATING LONG-TERM CARE PATIENTS WITH COPD

Abstract

SESSION TITLE: Monday Electronic Posters 4 SESSION TYPE: Original Inv Poster Discussion PRESENTED ON: 10/21/2019 02:30 PM - 03:15 PM PURPOSE: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity, mortality and increased health care resource utilization in long-term care (LTC) nursing home facilities in the US. Although GOLD guidelines recommend the use of long-acting bronchodilators (LABDs) for the treatment of COPD, as they are more effective and convenient than regular treatment with short-acting bronchodilators (SABDs), a large proportion of nursing home residents with a diagnosis of COPD do not receive any respiratory medication. Arformoterol tartrate (ARF; 15 μg twice daily [BID]) is a nebulized long-acting beta2-agonist (LABA) indicated for the maintenance treatment of bronchoconstriction in patients with COPD; ARF should not be used as rescue medication. In this post-hoc analysis, the efficacy of ARF was assessed in older COPD patients and in patients with very severe COPD. METHODS: Data from two identical, 12-week, multicenter, double-dummy, randomized Phase III trials (NCT00685841 and NCT00064402) evaluating improvement in airway function with ARF treatment in patients with COPD were pooled for analysis. Patients (n=1456; mean predicted forced expiratory volume in 1 second [FEV1]=40.6% [standard deviation: 12.8]) received nebulized ARF 15 μg BID, 25 μg BID, or 50 μg once daily (QD), salmeterol 42 μg BID (via metered dose inhaler), or placebo BID for 12 weeks. In order to assess the efficacy of ARF in patients with COPD representative of an LTC population, an analysis of improvement in airway function (as measured by FEV1) was performed comparing ARF 15 ug BID with placebo (BID) in a subset of patients defined by age (≥75 years; n=160) and baseline COPD disease severity (FEV1 <30% predicted; n=410). RESULTS: In the overall study population, the median % change in FEV1 was 2.05% among patients receiving placebo and 12.72% in patients treated with ARF 15 μg BID. In patients ≥75 years of age, the median % change in FEV1 was −5.22% in patients receiving placebo compared with 18.62% improvement in patients treated with ARF 15 μg BID. In patients with severe COPD disease (<30% FEV1 % predicted), the median % change in FEV1 was 5.13% among patients receiving placebo compared with 22.58% in patients treated with ARF 15 μg BID. CONCLUSIONS: Despite the recommendations for use of LABDs by GOLD guidelines, many LTC nursing home residents with COPD do not receive any respiratory medications. In this post-hoc analysis of patients with COPD representative of nursing facility residents (≥75 years of age; severe baseline disease), treatment with ARF 15 μg BID resulted in greater improvements in lung function when compared with placebo. CLINICAL IMPLICATIONS: LABDs such as ARF should be considered as a treatment option for residents in an LTC setting with a diagnosis of COPD. DISCLOSURES: Employee relationship with Sunovion Pharmaceuticals Please note: >$100000 Added 03/11/2019 by Thomas Goodin, source=Web Response, value=Salary Employee relationship with Sunovion Pharmaceuticals Please note: >$100000 Added 03/12/2019 by Ayca Ozol-Godfrey, source=Admin input, value=Salary Employee relationship with Sunovion Pharmaceuticals Please note: >$100000 Added 03/13/2019 by Barry Price, source=Web Response, value=Salary Employee relationship with Sunovion Pharmaceuticals Inc. Please note: >$100000 Added 03/14/2019 by Shahin Sanjar, source=Web Response, value=Salary Employee relationship with Sunovion Pharmaceuticals Inc. Please note: $20001 - $100000 Added 03/11/2019 by Sanjay Sharma, source=Web Response, value=Salary Removed 03/11/2019 by Sanjay Sharma, source=Web Response Employee relationship with Sunovion Pharmaceuticals, Inc. Please note: >$100000 Added 03/11/2019 by Sanjay Sharma, source=Web Response, value=Salary