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Helping patients with COPD breathe easier
Balanced information for better care
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2 Helping patients with COPD breathe easier
COPD is the fourth-leading cause of death1*
Older adults bear an increasing burden of disease.
Acute exacerbations account for 70% of COPD-related health care costs, with admissions accounting for $15 billion.4
2010 2020
$32.1 Billion
$49.0 Billion
Projected increase
Economic impact of COPD
FIGURE 2. The financial burden of COPD is rising.3
*In the U.S., after cancer, heart disease, and accidental injury.
FIGURE 1. People over 75 will make up over half of COPD patients by 2030.2
55-64 years old
65-74 years old
75+ years old
FemaleMale
Nu
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er d
iag
no
sed
wit
h C
OP
D, i
n t
ho
usa
nd
s 80
60
40
20
02001 2005 2010 2015 2020 2025 2030
Observed Predicted
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Alosa Health | Balanced information for better care 3
Diagnose COPD accurately, using spirometry whenever possibleThe diagnosis of COPD in patients with compatible symptoms is defined by an obstructive pattern on spirometry, even after bronchodilator treatment:
A significant FEV1 response to bronchodilators suggests asthma, whether in conjunction with COPD (asthma-COPD overlap) or on its own (if FEV1/FVC ≥0.7). Asthma is managed differently from COPD.
During the COVID-19 pandemic, limited availability of spirometry should not delay diagnosis and treatment. Try to obtain spirometry as soon as feasible.
Forced Expiratory Volume in 1 second (FEV1)
Forced Vital Capacity (FVC)
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4 Helping patients with COPD breathe easier
LABA: long-acting beta agonist; LAMA: long-acting muscarinic antagonist; ICS: inhaled corticosteroid
EXACERBATIONS:
Discrete episodes characterized by acute worsening of symptoms (i.e., increased dyspnea, sputum volume, purulence) beyond usual day-to-day variation and requiring intervention.
DAILY SYMPTOMS:
Defined according to either the mMRC scale,6 which focuses on dyspnea (scores from 0-4), or the COPD Assessment Test [CAT]),7 which includes dyspnea and other symptoms (scores from 0-40). See AlosaHealth.org/COPD for assessments.
Short-acting beta agonists (e.g., albuterol, levalbuterol) and/or short-acting muscarinic antagonists (e.g., ipratropium) can improve dyspnea and exercise tolerance. These medications should be offered to patients in all GOLD groups as rescue inhalers.
Once an initial therapy has been selected (Figure 3), adjustments may be needed depending on the progression of daily symptoms and exacerbations. For dyspnea that is worsening or not improving, follow Figure 4. For more frequent or continued exacerbations, follow Figure 5.
FIGURE 3. Initial treatment choice should be based on daily symptom severity and history of exacerbations, which define the GOLD groups.5
FEWER DAILY SYMPTOMS mMRC 0-1 or CAT
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Alosa Health | Balanced information for better care 5
FIGURE 4. If dyspnea is worsening or not improving, consider dual bronchodilators.5
If symptoms worsen or fail to improve
If symptoms worsen or fail to improve
* For patients already on ICS
• Consider switching devices or medications• Rule out or address other causes of dyspnea
LABA + LAMA LABA + LAMA + ICS
LABA or LAMA LABA + ICS* ICS do not have a role for dyspnea alone.
For dyspnea
For exacerbations
FIGURE 5. If exacerbations are increasing, use eosinophil levels to guide treatment.5
LABA or LAMA
LABA + ICS
NAre eosinophils ≥300 cells/μL or
≥100 cells/μL with exacerbations**? Y
If additional exacerbation(s)
LABA + LAMA + ICS
If additional exacerbation(s)
LABA + LAMA
**2 moderate exacerbations or 1 exacerbation requiring hospitalization
YNIf additional exacerbation(s),
are eosinophils ≥100 cells/μL?
Add roflumilast (if FEV1
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6 Helping patients with COPD breathe easier
Stop or replace ICS when appropriateRecent evidence shows that ICS increase the risk of pneumonia.
FIGURE 7. Outpatient management of exacerbations5
Treat exacerbations with bronchodilators, oral steroids, and/or antibiotics
Prescribe a short course of antibiotics for patients with increased sputum
purulence and increased symptoms.
Prescribe steroids for 5 days (e.g., prednisone 40 mg) for
exacerbations not responding to bronchodilators.
Re-evaluate to modify therapy and/or hospitalize as indicated.
Increase bronchodilator therapy for all patients (e.g., albuterol ± ipratropium).
+
Initiate or adjust maintenance treatment based on GOLD recommendations (pages 4-5).
Gradual withdrawal of ICS does not trigger exacerbations. In the WISDOM trial, a stepwise taper of ICS did not increase exacerbations.9
In the FLAME trial, patients treated with ICS had a 50% relative increase in the risk of pneumonia (4.8% with ICS vs 3.2% without ICS).8 With similarly effective alternative treatments available, ICS can safely be stopped in patients who do not have frequent exacerbations or a high eosinophil count.
FIGURE 6. Reassessing the need for inhaled steroids5
*Monotherapy selection based on GOLD group and symptom control.
Switch to LABA or LAMA* or
LABA + LAMA
Continue ICS
Y
Does the patient have any of the following?
• Recurrent pneumonia• No clear indication for ICS• Lack of response to ICS N
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Alosa Health | Balanced information for better care 7
Intensify treatment when COPD advancesDual therapy: LABA+LAMA reduces exacerbations more than LABA+ICS.
FIGURE 8. In the FLAME trial, LABA+LAMA reduced exacerbations more than LABA+ICS, and prolonged the time to first exacerbation.8
Pro
bab
ility
of
exac
erb
atio
n (
%)
Week
0 6 12 19 26 32 39 45 52
Moderate or severe
Hazard ratio, 0.84 (95% CI, 0.78–0.91) p
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8 Helping patients with COPD breathe easier
Helping patients quit smoking is keySmoking cessation is the most effective intervention to delay COPD symptoms, the onset of disability, and mortality.
FIGURE 10. Smoking and decline of lung function in COPD12
Age (years)
100
75
50
25
25 50 750
Never smoked or not susceptible to smoke
Stopped smoking at age 45
Stopped smoking at age 65
Death
Disability
Susceptible smoker
Create a plan for patients who are ready to quit.
Pharmacologic plus behavioral therapy offers the best prospects for quitting. Multiple attempts may be needed.153
Encourage patients to call 1-800-QUIT-NOW (1-800-784-8669) or text QUIT to 47848.
• Pharmacologic options include: — Nicotine replacement therapy: long-acting (transdermal patch) and short- acting (e.g., gum, lozenge, nasal spray, inhaler); available without prescription
— Prescriptions: varenicline (Chantix) OR bupropion (Wellbutrin, generics)
• When starting nicotine replacement, use a long-acting plus a short-acting agent.
• Varenicline is superior to bupropion and to long-acting nicotine replacement alone.14
• Nicotine replacement can be combined with either bupropion or varenicline.
Select treatment based on patient preferences, medical conditions, and cost.2
Provide or refer for behavioral support. Even brief, simple advice increases the likelihood of quitting. More intensive advice can result in higher quit rates.131
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Alosa Health | Balanced information for better care 9
Additional interventions for patients with COPD
Pulmonary rehabilitation5
This is one of the most cost- effective interventions for COPD. A 6- to 8-week program of twice weekly exercise training can reduce:
• dyspnea• symptoms of anxiety and depression• readmissions in patients with a
recent COPD hospitalization
Pneumococcal vaccination16
• Give Pneumovax (23-valent) once before age 65 and again at or after age 65.
• Discuss Prevnar (13-valent). Consider giving in patients with advanced disease given low risk and small incremental benefit.
Criteria for home oxygen in severe disease:
• O2 saturation ≤88% or PaO2 ≤55 mm Hg, or• PaO2 of 55-59 mm Hg with evidence of pulmonary hypertension,
cor pulmonale, hematocrit >55%, or
• PaO2 ≥60 mm Hg with exercise desaturation, sleep desaturation not corrected by continuous positive airway pressure (CPAP), or severe dyspnea that responds to oxygen therapy.19
Note: When titrating oxygen, aim for an O2 saturation >90%.
Prescribe oxygen in patients with chronic hypoxemia.17,18
Engage COPD patients in conversations about palliative care.
• COPD is a progressive disease that does not have a cure.• It causes worsening symptoms, deteriorating quality of life, frequent emergency room
visits, and hospitalizations.20
• Patients with end-stage COPD are far less likely than lung cancer patients to get palliative medications.
• In patients with end-stage COPD, low-dose opioids can help relieve refractory dyspnea without increasing the risk of death.21,22
A conversation about palliative care for COPD should focus on enhancing quality of life, optimizing function, and helping patients and families get the emotional and spiritual support they need.5
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10 Helping patients with COPD breathe easier
Prices of these regimens vary widely
Prices from goodrx.com, May 2020. Listed doses are based on Defined Daily Doses by the World Health Organization and should not be used for dosing in all patients. All doses shown are for generics when available, unless otherwise noted. These prices are a guide; patient costs will be subject to copays, rebates, and other incentives.
Not all inhalers are FDA approved to treat COPD.
FIGURE 11. Cost of an inhaler or 30-day drug supply
Patents on devices make many regimens very costly, even those including generic drugs.
SABA albuterol 90 mcg (Proair HFA, Proventil HFA, Ventolin HFA) $69
albuterol 90 mcg (generic HFA) $45
levalbuterol 45 mcg (Xopenex HFA) $81
levalbuterol 45 mcg (generic HFA) $54
ipratropium 17 mcg (Atrovent HFA) $436
olodaterol 2.5 mcg (Striverdi Respimat) $269
salmeterol 50 mcg (Serevent Discus) $432
aclidinium 400 mcg (Tudorza Pressair) $672
tiotropium 18 mcg (Spiriva Handihaler) $505
tiotropium 18 mcg (Spiriva Respimat) $508
umeclidinium 62.5 mcg (Incruse Ellipta) $403
budesonide 180 mcg (Pulmicort Flexhaler) $271
beclomethasone 80 mcg (QVAR Redihaler) $281
fluticasone 250 mcg (Flovent Discus) $283
fluticasone 220 mcg (Flovent HFA) $427
fluticasone 232 mcg (Armonair Digihaler) $233
fluticasone 200 mcg (Arnuity Ellipta) $285
mometasone 440 mcg (Asmanex Twisthaler) $245
mometasone 400 mcg (Asmanex HFA) $247
albuterol/ipratropium (Combivent Respimat) $504
formoterol 12 mcg/aclidinium 400 mcg (Duaklir Pressair) $1,218
formoterol 4.8 mcg/glycopyrrolate 9 mcg (Bevespi Aerosphere) $415
olodaterol 2.5 mcg/tiotropium 2.5 mcg (Stiolto Respimat) $495
valanterol 25 mcg/umeclidinium 62.5 mcg (Anoro Ellipta) $499
formoterol 4.5 mcg/budesonide 160 mcg (Symbicort) $392
formoterol 4.5 mcg/budesonide 160 mcg (generic) $282
formoterol 5 mcg/mometasone 100 mcg (Dulera) $350
salmeterol 21 mcg/fluticasone 115 mcg (Advair HFA) $434
salmeterol 50 mcg/fluticasone 250 mcg (Advair Discus) $433
salmeterol 50 mcg/fluticasone 250 mcg (Wixela Inhub) $170
salmeterol 50 mcg/fluticasone 250 mcg (generic) $171
vilanterol 25 mcg/fluticasone 100 mcg (Breo Ellipta) $408
vilaterol 25 mcg/umeclidinium 62.5 mcg/ fluticasone 100 mcg (Trelegy Ellipta) $635
varenicline 2 mg (Chantix) $469
bupropion SR 300 mg (generic) $30
bupropion SR 300 mg (Wellbutrin SR) $502
bupropion SR 300 mg (Zyban) $253
bupropion XL 300 mg (generic) $37
nicotine inhaler (Nicotrol) $518
nicotine gum 4 mg (Nicorette) $29
nitotine patch 14 mg (e.g., Nicoderm CQ) $61
$400$200 $500$300$1000 $600
SAMA
LABA
LAMA
ICS
SABA+SAMA
LABA+LAMA
LABA+ICS
LABA+LAMA+ICS
roflumilast 0.5 mg (Daliresp) $418PDE-4 inhibitor
Smoking cessation
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Alosa Health | Balanced information for better care 11
References: (1) Centers for Disease Control and Prevention, National Center for Health Statistics. Underlying Cause of Death 1999-2018 on CDC WONDER Online Database. http://wonder.cdc.gov/ucd-icd10.html. Published 2020. Accessed May 12, 2020. (2) Khakban A, Sin DD, FitzGerald JM, et al. The Projected Epidemic of Chronic Obstructive Pulmonary Disease Hospitalizations over the Next 15 Years. A Population-based Perspective. Am J Respir Crit Care Med. 2017;195(3):287-291. (3) Centers for Disease Control and Prevention. COPD costs. Updated February 21, 2018. Accessed June 24, 2020. (4) Press VG, Konetzka RT, White SR. Insights about the economic impact of chronic obstructive pulmonary disease readmissions post implementation of the hospital readmission reduction program. Curr Opin Pulm Med. 2018;24(2):138-146. (5) Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2020 report. (6) Stenton C. The MRC breathlessness scale. Occup Med (Lond). 2008;58(3):226-227. (7) Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009;34(3):648-654. (8) Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. N Engl J Med. 2016;374(23):2222-2234. (9) Magnussen H, Disse B, Rodriguez-Roisin R, et al. Withdrawal of inhaled glucocorticoids and exacerbations of COPD. N Engl J Med. 2014;371(14):1285-1294. (10) Rabe KF, Martinez FJ, Ferguson GT, et al. Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD. N Engl J Med. 2020;383(1):35-48. (11) Lipson DA, Barnhart F, Brealey N, et al. Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD. N Engl J Med. 2018;378(18):1671-1680. (12) Fletcher C, Peto R. The natural history of chronic airflow obstruction. Br Med J. 1977;1(6077):1645-1648. (13) Stead LF, Buitrago D, Preciado N, Sanchez G, Hartmann-Boyce J, Lancaster T. Physician advice for smoking cessation. Cochrane Database Syst Rev. 2013;2013(5):Cd000165. (14) Anthenelli RM, Benowitz NL, West R, et al. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet. 2016;387(10037):2507-2520. (15) van Eerd EA, van der Meer RM, van Schayck OC, Kotz D. Smoking cessation for people with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2016;2016(8):Cd010744. (16) Centers for Disease Control and Prevention. Pneumococal vaccine recommendations. https://www.cdc.gov/vaccines/vpd/pneumo/hcp/recommendations.html. Accessed June 16, 2020. (17) Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980;93(3):391-398.(18) Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party. Lancet. 1981;1(8222):681-686. (19) U.S. Department of Health and Human Services, U.S. Centers for Medicare and Medicaid Services (CMS), Medicare Learning Network. Home oxygen therapy. CMS. Accessed June 23, 2020. (20) Iyer AS, Goodrich CA, Dransfield MT, et al. End-of-Life Spending and Healthcare Utilization Among Older Adults with Chronic Obstructive Pulmonary Disease. Am J Med. 2019. (21) Currow DC, Quinn S, Greene A, Bull J, Johnson MJ, Abernethy AP. The longitudinal pattern of response when morphine is used to treat chronic refractory dyspnea. J Palliat Med. 2013;16(8):881-886. (22) Ekström MP, Bornefalk-Hermansson A, Abernethy AP, Currow DC. Safety of benzodiazepines and opioids in very severe respiratory disease: national prospective study. BMJ. 2014;348:g445.
Visit AlosaHealth.org/COPDfor links to a comprehensive evidence document and other resources.
Key messages
• Use spirometry to diagnose COPD.
• Classify patients based on daily symptoms and history of exacerbations according to the GOLD classification system, which can guide treatment.
• Adjust the regimen based on daily symptoms and exacerbations.
• For patients who smoke, assess their willingness to quit and tailor recommendations to their stage of readiness.
• Include non-drug interventions throughout the course of COPD:
— Recommend exercise, good nutrition, and immunizations for all patients.
— Refer selected patients to pulmonary rehabilitation.
• Treat acute exacerbations with short-acting bronchodilators, systemic steroids, and an antibiotic when indicated.
• Begin conversations about palliative and end-of-life care as the disease worsens.
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This material was produced by William Feldman, M.D., D.Phil., Fellow in Pulmonary and Critical Care Medicine; Michael A. Fischer, M.D., M.S., Associate Professor of Medicine (principal editor); Jerry Avorn, M.D., Professor of Medicine; and Dae Kim, M.D., Sc.D., Associate Professor of Medicine, all at Harvard Medical School; and Ellen Dancel, Pharm.D., M.P.H., Director of Clinical Materials Development at Alosa Health. Drs. Avorn, Feldman, and Fischer are physicians at the Brigham and Women’s Hospital, and Dr. Kim practices at the Beth Israel Deaconess Medical Center and Hebrew Senior Life, all in Boston. None of the authors accepts any personal compensation from any drug company.
Medical writer: Stephen Braun.
These are general recommendations only; specific clinical decisions should be made by the treating clinician based on an individual patient’s clinical condition. More detailed information on this topic is provided in a longer evidence document at AlosaHealth.org.
About this publication
The Independent Drug Information Service (IDIS) is supported by the PACE Program of the Department of Aging of the Commonwealth of Pennsylvania.
This material is provided by Alosa Health, a nonprofit organization which is not affiliated with any pharmaceutical company. IDIS is a program of Alosa Health.
Copyright 2020 by Alosa Health. All rights reserved. Aug 2020