Amir Sharafkhaneh1, Aylin E Altan2, Gene L Colice3, Nicola A Hanania4, James F Donohue5, Jonathan L Kurlander6, Roberto Rodriguez-Roisin7, Pablo R Altman8. 1. Pulmonary and Critical Care, Baylor College of Medicine, MEDVA Medical Center Bldg. 100 (111i), Houston, TX 77030, USA. Electronic address: amirs@bcm.edu. 2. Health Economics and Outcomes Research, OptumInsight, 13625 Technology Drive, Eden Prairie, MN 55344, USA. Electronic address: Aylin.Altan@optum.com. 3. Pulmonary, Critical Care and Respiratory Services, Washington Hospital Center, 110 Irving Street, Washington DC, 20010, USA. Electronic address: Gene.Colice@Medstar.net. 4. Pulmonary and Critical Care, Baylor College of Medicine, One Baylor Plaza-BCM621, Houston, TX 77030, USA. Electronic address: hanania@bcm.tmc.edu. 5. Pulmonary Diseases and Critical Care Medicine, University of North Carolina School of Medicine, 4125 BioInformatics Building, 130 Mason Farm Road, CB 7020, Chapel Hill, NC 27599, USA. Electronic address: james_donohue@med.unc.edu. 6. Health Economics and Outcomes Research, OptumInsight, 13625 Technology Drive, Eden Prairie, MN 55344, USA. Electronic address: Jonathan.Kurlander@optum.com. 7. Thorax Institute, Hospital Clinic-CIBERES, IDIBAPS, Universitat de Barcelona, Villarroel, 170 (Esc 2 - Planta 2), 08036 Barcelona, Spain. Electronic address: rororo@clinic.ub.es. 8. Mylan Specialty, L.P., 110 Allen Road, 4th Floor, Basking Ridge, NJ 07920, USA. Electronic address: Pablo.Altman@gmail.com.
Abstract
BACKGROUND: A simple rule based on short-acting inhaled β2-agonist (SABA) use could identify patients with chronic obstructive pulmonary disease (COPD) at increased risk of exacerbations and signal the need for maintenance therapy change, similar to asthma "Rules of Two(®)". METHODS: Associations between SABA use, COPD exacerbations, and health care costs over 1 year were examined retrospectively using de-identified patient data from the Optum Research Database (ORD; N = 56,581) and the Impact National Benchmark Database (IMPACT™; N = 9423). Nebulized and metered-dose inhaler (MDI) SABA doses were normalized to 2.5 mg and 90 mcg albuterol equivalents, respectively. RESULTS: The GOLD initiative establishes ≥2 exacerbations/year as indicative of increased risk in COPD. We identified a correlation (p < 0.0001) between 1.5 SABA doses/day and this frequency of exacerbations. In ORD, patients using ≥1.5 versus <1.5 SABA doses/day experienced significantly more exacerbations: 1.92 (95% confidence interval [CI], 1.89-1.96) versus 1.36 (95% CI, 1.34-1.38) per patient year (PPY). Above-threshold use was associated with higher average annual COPD-related costs (2010 $US): $21,868 (standard deviation [SD], $53,910) versus $11,686 (SD, $32,707) for nebulized SABA only, $9216 (SD, $30,710) versus $7334 (SD, $24,853) for MDI SABA only, and $15,806 (SD, $35,260) versus $11,233 (SD, $27,006) for both nebulized and MDI SABA. IMPACT™ validated these findings. CONCLUSION: Patients with COPD using ≥1.5 SABA doses/day were at increased risk of exacerbations. Our results suggest a "Rule of 3-2": SABA use ≥3 times in 2 days should be considered a clinical marker for needing treatment reevaluation.
BACKGROUND: A simple rule based on short-acting inhaled β2-agonist (SABA) use could identify patients with chronic obstructive pulmonary disease (COPD) at increased risk of exacerbations and signal the need for maintenance therapy change, similar to asthma "Rules of Two(®)". METHODS: Associations between SABA use, COPD exacerbations, and health care costs over 1 year were examined retrospectively using de-identified patient data from the Optum Research Database (ORD; N = 56,581) and the Impact National Benchmark Database (IMPACT™; N = 9423). Nebulized and metered-dose inhaler (MDI) SABA doses were normalized to 2.5 mg and 90 mcg albuterol equivalents, respectively. RESULTS: The GOLD initiative establishes ≥2 exacerbations/year as indicative of increased risk in COPD. We identified a correlation (p < 0.0001) between 1.5 SABA doses/day and this frequency of exacerbations. In ORD, patients using ≥1.5 versus <1.5 SABA doses/day experienced significantly more exacerbations: 1.92 (95% confidence interval [CI], 1.89-1.96) versus 1.36 (95% CI, 1.34-1.38) per patient year (PPY). Above-threshold use was associated with higher average annual COPD-related costs (2010 $US): $21,868 (standard deviation [SD], $53,910) versus $11,686 (SD, $32,707) for nebulized SABA only, $9216 (SD, $30,710) versus $7334 (SD, $24,853) for MDISABA only, and $15,806 (SD, $35,260) versus $11,233 (SD, $27,006) for both nebulized and MDISABA. IMPACT™ validated these findings. CONCLUSION:Patients with COPD using ≥1.5 SABA doses/day were at increased risk of exacerbations. Our results suggest a "Rule of 3-2": SABA use ≥3 times in 2 days should be considered a clinical marker for needing treatment reevaluation.
Authors: Robert A Wise; Russell A Acevedo; Antonio R Anzueto; Nicola A Hanania; Fernando J Martinez; Jill A Ohar; Donald P Tashkin Journal: Chronic Obstr Pulm Dis Date: 2016-11-15
Authors: Jessica Chen; Leanne Kaye; Michael Tuffli; Meredith A Barrett; Shelanda Jones-Ford; Tina Shenouda; Rahul Gondalia; Kelly Henderson; Veronica Combs; David Van Sickle; David A Stempel Journal: JMIR Form Res Date: 2019-10-23