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Balanced information for better care Helping patients with COPD breathe easier COPD is the third-leading cause of death in the U.S., following cancer and heart disease1 Women have overtaken men in annual COPD deaths. FIGURE 1. COPD deaths by gender 2.3 135,000 total deaths 80,000 122,000 total deaths Number of deaths 70,000 60,000 54,000 total deaths 50,000 147,101 total deaths Women Men 83,000 total deaths 40,000 30,000 20,000 10,000 0 1979 1989 1999 2009 2014 Year Patients with COPD cost $6000 more per year than other patients.4 Primary care providers play a central role in managing these patients. • COPD is substantially under-diagnosed. • It can occur at an earlier age than is generally believed. • Early diagnosis and aggressive treatment can: ——reduce ——slow mortality disease progression and relieve symptoms ——improve ——reduce 2 pulmonary function and quality of life exacerbations Helping patients with COPD breathe easier Using symptoms plus spirometry improves the diagnosis and staging of COPD • Suspect COPD in patients over age 40 with dyspnea, chronic cough or sputum production, and a history of smoking or exposure to other risk factors. • FEV1 /FVC ratio <0.70 (post-bronchodilator) confirms COPD. TABLE 1. The GOLD Classification Scheme can guide treatment5 Postbronchodilator FEV1 Exacerbations Symptoms* >50% of predicted <50% of predicted AND AND/OR <2 per year ≥ 2 per year LOW RISK HIGH RISK Moderate Severe Moderate Severe GROUP A GROUP B GROUP C GROUP D [low risk of [low risk of [high risk of [high risk of exacerbation, exacerbation, exacerbation, exacerbation, fewer symptoms] more symptoms] fewer symptoms] more symptoms] *Severe symptoms: walking slower than people of the same age because of breathlessness or needing to stop for breath on level ground (MMRC scale6). Other clinical factors may influence treatment decisions: • Functional impairment (e.g., exercise tolerance, ability to perform activities of daily living) • Co-morbidities (e.g., co-existing asthma) Repeat spirometry if symptoms worsen significantly. Routine spirometry in stable disease is unnecessary. Alosa Health | Balanced information for better care 3 Smoking cessation is the most effective single action to delay COPD symptoms, onset of disability, and mortality 7 FIGURE 2. Smoking and decline of lung function in COPD 8 Lung function FEV1 (% of value at age 25) 100 Susceptible smoker 75 Never smoked or not susceptible to smoke 50 Stopped smoking at age 45 Disability 25 Stopped smoking at age 65 Death 0 25 50 Years 75 Even brief, simple advice about quitting smoking increases the likelihood that a smoker will successfully quit and remain a nonsmoker 12 months later. More intensive advice may result in higher rates of quitting.9 Encourage patients to call 1-800-QUIT-NOW (1-800-784-8669) for help or text QUIT to 47848 to receive text messages. Visit AlosaHealth.org/modules/COPD for more resources and information about smoking cessation. 4 Helping patients with COPD breathe easier First, assess willingness to quit: Tailoring recommendations to the stage of readiness can increase success. The five As of assessing readiness to quit smoking: Ask: Identify tobacco use at every visit; electronic prompts for clinicians can be helpful. Advise: Strongly urge all tobacco users to quit, using a clear and personalized message. Assess: Determine willingness to make a quit attempt. Assist: Help with a quit plan; recommend support programs and medications if required. Arrange: Schedule follow-up contact, in person or by telephone. Multiple drug therapy options are available to support patients who are ready to quit. • Over-the-counter: ——nicotine replacement therapy (gum, lozenges, transdermal patches, inhaled and nasal spray) • Prescription medications: ——bupropion (Zyban, Wellbutrin, generics) ——varenicline (Chantix) • Nicotine replacement products may be combined with either bupropion or varenicline. • Many options are available if multiple quit attempts are required. • For patients with COPD, there is no comparison to show that one drug is better than another.10 Treatment options may be selected based on patient preference, cost, and relevant medical and/or psychiatric conditions. Alosa Health | Balanced information for better care 5 Match drug therapy to disease severity TABLE 2. Pharmacological management of COPD 5 Group A Group B Group C Group D First line therapy Short-acting ß-agonist PRN (SABA) Long-acting ß-agonist (LABA) Inhaled corticosteroid (ICS)+ long-acting ß-agonist (LABA) Inhaled corticosteroid (ICS)+ long-acting ß-agonist (LABA) —OR— —OR— —OR— —AND/OR— Short-acting anticholinergic PRN, or “short-acting muscarinic antagonist” (SAMA) Long-acting anticholinergic, or “long-acting muscarinic antagonist” (LAMA) Long-acting anticholinergic, or “long-acting muscarinic antagonist” (LAMA) Long-acting anticholinergic, or “long-acting muscarinic antagonist” (LAMA) Add short-acting bronchodilators as rescue medication as needed Optional alternative therapies: Group A: [SABA + SAMA] or [LABA] or [LAMA] Group B: [LABA + LAMA] Group C: [LABA + LAMA] or [LAMA + roflumilast] or [LABA + roflumilast] Group D: [ICS + LABA + LAMA] or [ICS + LABA + roflumilast] or [LABA + LAMA] or [LAMA + roflumilast] Short- and long-acting bronchodilators Short-acting SABA • albuterol (Proventil HFA) • levalbuterol (Xopenex HFA) Long-acting SAMA • ipratropium (Atrovent and generics) LABA • salmeterol (Serevent) • formoterol (Foradil) • aformoterol (Brovana) • indacaterol (Arcepta) LAMA • tiotropium (Spiriva) • aclidinium (Tudorza) • umeclidinium (Incruse) • olodaterol (Striverdi) Ensure the patient can demonstrate proper use of inhalers and spacers. See AlosaHealth.org/modules/COPD for links to videos for patient education. 6 Helping patients with COPD breathe easier Step up treatment as symptoms escalate Start with a single SABA or SAMA. A combination of short-acting therapy may result in improved lung function and is an alternative choice, though the COMBIVENT study found that combination therapy with albuterol and ipratropium did not improve symptoms more than monotherapy.11 For increasing symptoms, LABAs and LAMAs reduce exacerbations and provide more relief than short-acting agents. The POET-COPD trial found that tiotropium was more effective than salmeterol in reducing the risk of moderate to severe exacerbations.12 For more severe patients, combination therapy may be warranted. While LABA + ICS and LAMA are both effective,13 the FLAME study found that combined bronchodilation with LAMA + LABA delayed time to exacerbation and reduced exacerbations overall compared with a LABA + ICS. Symptoms improved and use of rescue inhaler was lower in the LAMA + LABA group as well.14 Some patients may require triple therapy (LABA + LAMA + ICS).15 Reserve phosphodiesterase-4 (PDE-4) inhibitors (e.g., roflumilast) for patients with an FEV1 <50% who have frequent exacerbations despite optimal conventional therapy.16 Prescribe home oxygen in severe disease if: • 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.17 At least 15 hours/day of oxygen or more improves survival.18,19 Note: When titrating oxygen, aim for an O2 saturation >90%. Alosa Health | Balanced information for better care 7 Prescribe exercise, good nutrition, and immunizations at all stages of the disease TABLE 3. Non-pharmacological interventions for COPD 5 Group A Group B Group C Group D Smoking cessation Reduce occupational and environmental exposures Exercise/physical therapy Good nutrition Influenza and pneumococcal vaccines Pulmonary rehabilitation Pulmonologist referral Address end-of-life decision making Consider surgery in selected patients Exercise and pulmonary rehabilitation Pulmonary rehabilitation reduces hospital admissions and mortality. It also increases exercise capacity, reduces breathlessness symptoms, improves quality of life, relieves anxiety and depression, and reduces days spent in hospital.5 Relative risk reduction compared to usual care (%) FIGURE 3. Pulmonary rehab reduces hospital admissions and mortality after an exacerbation20 0 • Standard duration is 6 weeks; then continue exercise at home. -10 -20 • If a formal program is unavailable, encourage a walking regimen, building slowly to 20 minutes/day. -30 -40 -50 -60 -70 -52% -60% Hospital admissions Mortality ——An inexpensive finger pulse oximeter may enable patients to safely build exercise tolerance and avoid excessive desaturation. Immunization • Annual influenza vaccination reduces mortality 21 and risk of exacerbations.22 • Provide pneumococcal vaccination for all patients with COPD.23 8 Helping patients with COPD breathe easier Exacerbations reduce long-term lung function and increase mortality Exacerbations are characterized by worsening symptoms (e.g., worsening dyspnea, increased volume or purulence of sputum, cough). Prevent exacerbations by: 3promoting smoking cessation 3monitoring proper inhaler use 3ensuring adherence to prescribed regimens 3providing influenza immunizations FIGURE 4. Most exacerbations can be managed in the outpatient setting.5 • Increase bronchodilator therapy. —SABA with or without SAMA are preferred. • Add oral prednisone. —The REDUCE trial found that prednisone 40 mg/day for 5 days achieved equivalent outcomes to a 14-day regimen.24 • Add antibiotics in patients with increased sputum purulence plus worsening dyspnea or increased sputum volume. —Base the choice of antibiotic on local resistance patterns. —Examples include amoxicillin +/- clavulanic acid (e.g. Augmentin). —If penicillin allergy, use a macrolide, doxycycline, or tetracycline. Improvement or resolution of symptoms within 24 hours? ! Y N Step down therapy as possible. Review management plan. Hospitalize Oral corticosteroids—for acute exacerbations only Avoid long-term use of oral steroids in COPD because of the risk of osteoporosis, hypertension, hyperglycemia, and other adverse effects. Alosa Health | Balanced information for better care 9 Costs FIGURE 5. Price per month of medications used for the treatment of COPD and smoking cessation SABA $23 albuterol (Ventolin HFA) $84 albuterol (Proair HFA, Proventil HFA) $17 albuterol (generic) for nebulization $85 levalbuterol (Xopenex HFA) SAMA $24 iptratropium (generic) for nebulization $398 ipratropium (Atrovent HFA) LABA $250 formoterol (Foradil) $989 aformoterol (Brovana) $227 indacaterol (Arcapta) $425 salmeterol (Serevent Discus) LAMA aclidinium (Tudorza Pressair) $387 tiotropium (Spiriva) $389 $330 umeclidinium (Incruse Ellipta) SABA / SAMA $354 albuterol/ipratropium (Combivent) LABA / LAMA indacaterol 27.5 mcg/glycopyrrolate 15.6 mcg (Utibron Neohaler) $321 $376 valanterol 25 mcg/umeclidinium 62.5 mcg (Anoro Ellipta) $322 formoterol 4.8 mcg/glycopyrrolate 9 mcg (Bevespi Aerosphere) $361 olodaterol 2.5 mcg/tiotropium 2.5 mcg (Stiolto Respimat) ICS $274 budesonide 180 mcg (Pulmicort) $245 beclomethasone 80 mcg (QVAR) $262 fluticasone 250 mcg (Flovent Discus) LABA/ICS $334 budesonide 160 mcg/formoterol 4.5 mcg (Symbicort) $382 fluticasone 250 mcg/salmeterol 50 mcg (Advair Discus) $341 fluticasone 100 mcg/vilanterol 25 mcg (Breo Ellipta) PDE-4 inhibitor Smoking cessation $351 roflumilast (Daliresp) 0.5 mg tablet $412 varenicline 2 mg (Chantix) $73 bupropion SR 300 mg (generic) $448 bupropion SR 300 mg (Wellbutrin SR) $243 bupropion SR 300 mg (Zyban) $433 nicotine inhaler (Nicotrol) nicotine gum 4 mg (Nicorette) $53 nitotine patch 14 mg (Nicoderm CQ) $53 0 * Prices from goodrx.com September 2016. 10 Helping patients with COPD breathe easier $200 $400 $600 $800 $1000 Key messages • Use spirometry and clinical symptoms to diagnose and follow COPD patients according to the GOLD 4-group classification system. • For patients who smoke, begin by assessing their willingness to quit. Tailoring recommendations appropriate for their stage of readiness will increase success. • Prescribe a regimen of exercise, good nutrition, and immunizations at all stages of COPD. ——Refer to formal pulmonary rehab (as a form of exercise) if available. • Match drug therapy to disease severity according to the GOLD 4-group system. ——Begin with prn inhaled bronchodilators (SABA and/or SAMA). ——Sequentially add long-acting agents including inhaled corticosteroids. ——PDE-4 inhibitors may be an alternative long-acting agent for some with severe disease. • Prescribe oxygen for patients with chronic hypoxemia. • Treat acute exacerbations aggressively with short-acting bronchodilators, systemic steroids, and an antibiotic when appropriate. Visit AlosaHealth.org/modules/COPD for patient resources and more detailed information References: (1) American Lung Association. Trends in COPD (Chronic Bronchitis and Emphysema): Morbidity and Mortality. 2013. (2) Centers for Disease Control and Prevention. National Center for Health Statistics, CDC Wonder on-line database, compiled from compressed mortality file. 1979-2009. 2012;No. 20. (3) Centers for Disease Control and Prevention. National Center for Health Statistics. National Vital Statistics Reports 2010 to 2014. http://www.cdc.gov/nchs/products/nvsr.htm (4) Ford ES, Murphy LB, Khavjoy O, et al. Total and state-specific medical and absenteeism costs of COPD among adults aged ≥ 18 years in the United States for 2010 and projections through 2020. Chest. 2015;147:31-45. (5) GOLD. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2016. (6) Stenton C. The MRC breathlessness scale. Occup Med. 2008;58(3):226-227. (7) Godtfredsen NS, Lam TH, Hansel TT, et al. COPD-related morbidity and mortality after smoking cessation: status of the evidence. Eur Respir J. 2008;32(4):844-853. (8) Fletcher C, Peto R. The natural history of chronic airflow obstruction. BMJ. 1977;(1(6077)):1645-1648. (9) Stead LF, Bergson G, Lancaster T. Physician advice for smoking cessation. Cochrane Database Syst Rev. 2008(2):CD000165. (10) van Eerd EAM, van der Meer RM, vanSchayck OCP, Kotz D. Smoking cessation for people with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2016: CD010744. (11) Routine nebulized ipratropium and albuterol together are better than either alone in COPD. The COMBIVENT Inhalation Solution Study Group. Chest. 1997;112(6):1514-1521. (12) Vogelmeier C, Hederer B, Glaab T, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. NEJM. 2011;364(12):1093-1103. (13) Wedzicha JA, Calverley PM, Seemungal TA, Hagan G, Ansari Z, Stockley RA. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. Am J Respir Crit Care Med. 2008;177(1): 19-26. (14) Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-glycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med. 2016;374:2222-34. (15) Singh D, Papi A, Corradi M, et al. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting ß2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomized controlled trial. Lancet. 2016;388:963-73. (16) Chong J, Poole P, Leung B, Black PN. Phosphodiesterase 4 inhibitors for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2011(5):CD002309. (17) American Thoracic Society ERS. Standards for the Diagnosis and Manangement of Patients with COPD. 2004. (18) Nocturnal Oxygen Therapy Trial Group. Continuous or nocturnal oxygen therapy in hypozemic chronic obstructive lung disease: a clinical trial. Ann Intern Med. 1980;93(3):391-398. (19) 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. (20) Puhan M, Gimeno-Santos E, Scharplatz M, Troosters T, Walters EH, Steurer J. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2011(10):CD005305. (21) Schembri S, Morant S, Winter JH, MacDonald TM. Influenza but not pneumococcal vaccination protects against all-cause mortality in patients with COPD. Thorax. 2009;64(7):567-572. (22) Poole PJ, Chacko E, Wood-Baker RW, Cates CJ. Influenza vaccine for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2006(1):CD002733. (23) Nichol KL, Baken L, Wuorenma J, Nelson A. The health and economic benefits associated with pneumococcal vaccination of elderly persons with chronic lung disease. Arch Intern Med. 1999;159(20):2437-2442. (24) Leuppi JD, Schuetz P, Bingisser R, et al. Short-term vs conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE randomized clinical trial. JAMA. 2013;309(21):2223-2231. Alosa Health | Balanced information for better care 11 About this publication These are general recommendations only; specific clinical decisions should be made by the treating physician based on an individual patient’s clinical condition. More detailed information on this topic is provided in a longer evidence document at AlosaHealth.org. This material is provided by Alosa Health, a nonprofit organization which is not affiliated with any pharmaceutical company. This material was produced by Michael H. Cho, M.D., MPH, Assistant Professor of Medicine; Michael A. Fischer, M.D., M.S., Associate Professor of Medicine; Niteesh K. Choudhry, M.D., Ph.D., Professor of Medicine; Jerry Avorn, M.D., Professor of Medicine, all at Harvard Medical School; and Ellen Dancel, PharmD, MPH, Director of Clinical Material Development at Alosa Health. Drs. Avorn, Cho, Choudhry, and Fischer are all physicians at the Brigham and Women’s Hospital in Boston and do not accept any personal compensation from any drug company. Medical writer: Stephen Braun. Copyright 2016 by Alosa Health. All rights reserved.