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Donald A Mahler, MD1 Edward Kerwin, MD2 Lindsey Murray, PhD, MPH3 Carole Dembek, MS4
Author Affiliations
- Geisel School of Medicine at Dartmouth, Hanover, New Hampshire
- Clinical Research Institute of Southern Oregon, Medford, Oregon
- Evidera, Bethesda, Maryland
- Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts
Address correspondence to:
Carole Dembek
Sunovion Pharmaceuticals Inc.
84 Waterford Drive
Marlborough, MA 01752
Phone: +1 508-357-7704
Email: carole.dembek@sunovion.com
Abstract
Background: Chronic cough, dyspnea, and excessive sputum production, the characteristic symptoms of chronic obstructive pulmonary disease (COPD), can negatively affect patients’ health-related quality of life (HRQoL). The fixed-dose combination of a long-acting beta2-adrenergic agonist and a long-acting muscarinic antagonist (LABA/LAMA) have been shown to improve HRQoL and COPD symptoms as measured by the St George’s Respiratory Questionnaire (SGRQ) and the Transition Dyspnea Index (TDI) total scores. However, the impact of a LABA/LAMA on the individual components of HRQoL and dyspnea with daily activities is unknown.
Methods: Secondary analysis of pooled data from 2 replicate, phase 3, 12-week, randomized, placebo, and active-controlled trials of twice-daily indacaterol/glycopyrrolate (IND/GLY) were analyzed. Change from baseline in HRQoL and dyspnea was measured by SGRQ and TDI, respectively. Total and component scores were evaluated using linear mixed models. Logistic regression was used to analyze the proportion of patients achieving minimum clinically important difference. Study outcomes were further explored in patient subgroups.
Results: A total of 2038 patients from FLIGHT1/FLIGHT2 studies were evaluated. IND/GLY significantly improved SGRQ component scores (symptoms [–7.3], activity [–3.6], and impacts [–5.0]); all P < 0.001 compared with placebo. IND/GLY also significantly improved symptoms scores compared with IND and GLY (–3.5 and –3.7, respectively; both P < 0.001). Patients treated with IND/GLY also had significant improvements in TDI component scores compared with placebo: functional impairment (0.48), magnitude of task (0.61), and magnitude of effort (0.54); all P < 0.001. All component scores were significantly higher for IND/GLY compared with IND and GLY (P ≤ 0.002 for all).
Conclusions: Twice-daily IND/GLY significantly improved total scores as well as components of HRQoL and dyspnea in patients with COPD. These data demonstrate multiple clinical benefits of LABA/LAMA maintenance therapy in the COPD population.
ClinicalTrials.gov: NCT 01727141 and NCT 01712516
Citation
Citation: Mahler DA, Kerwin E, Murray L, Dembek C. The impact of twice-daily indacaterol/glycopyrrolate on the components of health-related quality of life and dyspnea in patients with moderate-to-severe chronic obstructive pulmonary disease. Chronic Obstr Pulm Dis. 2019; 6(4):In press. doi: http://dx.doi.org/10.15326/jcopdf.6.4.2019.0131
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Maryam Navaie, DrPH, MBA1,2 Bartolome R. Celli, MD3 Zhun Xu, PhD4 Soojin Cho-Reyes, PhD1 Carole Dembek, MS5 Todd P. Gilmer, PhD4
Author Affiliations
- Advance Health Solutions, New York, New York
- School of Professional Studies, Columbia University, New York, New York
- Harvard Medical School and Chronic Obstructive Pulmonary Disease Center, Brigham and Women’s Hospital, Boston, Massachusetts
- Department of Family Medicine and Public Health, Division of Health Policy, University of California San Diego, La Jolla
- Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts
Address correspondence to:
Maryam Navaie, DrPH, MBA
Advance Health Solutions, LLC
5 Penn Plaza, 23rd Floor
New York, NY 10001
Phone : (212) 835-1510
E-mail: mnavaie@advancehealthsolutions.com
Abstract
Background: Long-acting beta2-agonists (LABAs), with or without inhaled corticosteroids (ICSs), delivered by handheld inhalers or nebulizers are recommended as maintenance therapy in chronic obstructive pulmonary disease (COPD). This study evaluated exacerbations, health resource utilization (HRU), and costs among Medicare beneficiaries with COPD on handheld ICS+LABA who switched to nebulized arformoterol (ARF) or continued ICS+LABA following a respiratory event.
Methods: Using Medicare claims, we identified beneficiaries with COPD (international classification of disease, 9th revision, clinical modification [ICD-9-CM] 490-492.xx, 494.xx, 496.xx) between 2010-2014 who had ≥ 1 year of continuous enrollment in Parts A, B, and D; ≥ 2 COPD-related outpatient visits ≥ 30 days apart or ≥ 1 hospitalization(s); ICS+LABA use 90-days before ARF initiation; and a respiratory event (COPD-related hospitalization or emergency department [ED] visit < 30 days before ARF initiation). Using propensity scores, 423 beneficiaries who switched to ARF were matched to 423 beneficiaries who continued on handheld ICS+LABA (controls). Difference-in-difference regression models examined outcomes at 180-days follow-up.
Results: Beneficiaries who switched to ARF had 1.5 fewer exacerbations (p=0.015) but no difference in hospitalizations and ED visits compared to controls. Durable medical equipment (DME) costs were higher among ARF users than controls ($1590), yet total health care costs were similar due to cost offsets by ARF in pharmacy (-$794), inpatient (-$524), and outpatient care (-$65). ARF accounted for 55% ($886.63) of DME costs, with the remaining costs attributed to oxygen therapy ($428.10) and nebulized corticosteroids ($590.85).
Conclusions: Switching from handheld ICS+LABA to nebulized ARF resulted in fewer COPD exacerbations among Medicare beneficiaries. Nebulized LABAs may improve outcomes in selected patients with COPD.
Citation
Citation: Navaie M, Celli BR, Xu Z, Cho-Reyes S, Dembek C, Gilmer, TP. Exacerbations, health resource utilization, and costs among Medicare beneficiaries with chronic obstructive pulmonary disease treated with nebulized arformoterol following a respiratory event. Chronic Obstr Pulm Dis. 2019; 6(4):In press. doi: http://dx.doi.org/10.15326/jcopdf.6.4.2019.0127
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