COPD Visual Toolkit Slides.pptx
- 1. COPD Visual Toolkit Fernando Martinez, MD, MS Chief, Pulmonary and Critical Care Medicine Division Weill Cornell Medicine Barbara Yawn, MD, MSc, FAAFP Adjunct Professor, Dept of Family and Community Health University of Minnesota
- 2. Can provide longitudinal picture of progress or decline © 2021, Global Initiative for Chronic Obstructive Lung Disease, available from www.goldcopd.org, published in Deer Park, IL, USA.
- 3. A Quick Functional Status Assessment © 2021, Global Initiative for Chronic Obstructive Lung Disease, available from www.goldcopd.org, published in Deer Park, IL, USA.
- 4. CAT, COPD Assessment Test; eos, blood eosinophil count (cells/L); ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; mMRC, modified Medical Research Council dyspnea questionnaire. © 2021, Global Initiative for Chronic Obstructive Lung Disease, available from www.goldcopd.org, published in Deer Park, IL, USA.
- 5. Factors to Consider When Initiating ICS Treatment Agusti et al, 2018. FACTORS TO CONSIDER WHEN INITIATING ICS TREATMENT Factors to consider when initiating ICS treatment in combination with 1 or 2 long-acting bronchodilators (note the scenario is different when considering ICS withdrawal): STRONG SUPPORT CONSIDER USE AGAINST USE • History of hospitalization(s) for exacerbations of COPD* • ≥2 moderate exacerbations of COPD per year* • Blood eosinophils >300 cells/µL • History of or concomitant asthma • 1 moderate exacerbation of COPD per year* • Blood eosinophils 100-300 cells/µL • Repeated pneumonia events • Blood eosinophils <100 cells/µL • History of mycobacterial infection *Despite appropriate long-acting bronchodilator maintenance therapy Note that blood eosinophils should be seen as a continuum; quoted values represent approximate cut-points; eosinophil counts are likely to fluctuate.
- 6. Case 1: Jon, 58-Year-Old Smoker Reason for visit—wife wanted “tiredness” checked out She says I spend too much time lazing around in house Retired from construction work—was “getting old” and had trouble keeping up with job--SOB Told he might have COPD in ED visit for “bad cold”. Given antibiotics and “inhaler” and “as needed rescue”—might help but seldom used. PMH History of hypertension, hyperlipidemia and “prediabetes” Still smokes 10 cigarettes per day On statin, diuretic and ACE inhibitor—same dose for past 8 years. Trying to deal with “prediabetes” with diet and exercise—“not working well— too tired to exercise” ACE, angiotensin converting enzyme; ED, emergency department; PMH, past medical history; SOB, shortness of breath.
- 7. Case 1: Jon, 58-Year-Old with 30-Year Smoking History (cont.) Today’s evaluation: BP 144/92, pulse 78, resp 20, BMI 34.5, HEENT—nl, Chest--Decreased breath sounds, Heart—RR no murmurs or gallops, Abd—nl, Ext-1+ edema mMRC is 2, CAT is 18 Spirometry-- FEV1/FVC .62 and FEV1—62% predicted CXR—no mass, no cardiomegaly, no infiltrates abd, abdomen; BMI, body mass index; BP, blood pressure; CXR, chest X-ray; FEV1/FVC, proportion of vital capacity expired in the first second of forced expiration to full, forced vital capacity; HEENT, head, eyes, ears, nose, and throat; nl, normal; RR, regular rate.
- 8. Treating Jon’s COPD Inform and educate regarding COPD diagnosis An ongoing activity Get up to date on immunizations, check lipids and HgbA1C, support smoking cessation. Pharmacotherapy Dual bronchodilator therapy vs LAMA alone Continue SABA as needed and carry with him Smoking cessation therapies Complete inhaler education and teach back. Give link to sites for review at home Follow up—see again in 6 to 12 weeks with follow up earlier if required for lab results. CT lung cancer screening—ask for comments on cardiac calcification and emphysema. CT, computed tomography; SABA, short-acting beta agonists.
- 9. Continuing adjustments in therapy are based on symptoms and exacerbations with strategies for each © 2021, Global Initiative for Chronic Obstructive Lung Disease, available from www.goldcopd.org, published in Deer Park, IL, USA.
- 10. Case 2: Marci, 58-Year-Old with COPD Diagnosed 3 Years Ago Reason for today’s visit Thinks she has acute bronchitis again Coughing, more shortness of breath and maybe coughing up “stuff” Using “dual therapy”—LAMA+LABA---remembers most days Has not refilled that red rescue ---well ever PMH FEV1 predicted of 54% at diagnosis Has been to ED twice this year for acute bronchitis and treated with steroid burst and antibiotics each time Told to continue her dual bronchodilator therapy Also has hyperlipidemia, and stopped smoking 5 years ago but admits to “vaping occasionally for stress” Wants treatment for her current problem
- 11. Case 2: Marci, 58-Year-Old with COPD Diagnosed 3 Years Ago (cont.) Examination today BP 124/72, pulse 86, resp 24, coughing frequently, pulse ox-92%, T- 99 F BMI 26.1 HEENT URI-like inflammation Chest—wheezes and crackles Heart—RR, no murmurs or gallops Ext---no edema Could not do peak flow due to coughing CAT is 26, mMRC is 3 today CXR---no infiltrates, heart--nl T, temperature; URI, upper respiratory infection.
- 12. Treating Marci’s exacerbation and more Treat acute exacerbation Oral steroid burst—probably no need for antibiotics Now third exacerbation in past 12 to 15 months; right side of GOLD diagram Add ICS to LABA + LAMA—role of eos? (GOLD and ATS differ ) If already on triple RX---refer—can refer earlier if desired. ? Roflumilast or Azithromycin Even though acute issue, do check up steps Check inhaler technique Check ability and current level of adherence to daily RX Assess trigger or exposures---someone smoking in the house or other place she goes?? Ask goals and discuss importance of regular follow up care. Consider spirometry---better now or in 6 weeks??? Pulmonary rehab—in person or online---can be helpful to do at time of “event” CT lung cancer screening—ask for comments on cardiac calcification and emphysema Consider referral for second opinion and what you may have missed ATS, American Thoracic Society.
- 13. ETHOS and IMPACT: Effect of Fixed-Dose Triple Therapy on Moderate or Severe Exacerbations BFF, budesonide/formoterol fumarate; BGF, budesonide/glycopyrrolate/formoterol fumarate; GFF, glycopyrrolate/formoterol fumarate; FF, fluticasone furoate; RR, rate ratio; UMEC, umeclidinium; VI, vilanterol. There have been no head-to-head comparative studies between both triple therapy. Lipson et al, 2018; Rabe et al, 2020. ETHOS: Moderate or Severe COPD Exacerbation in the Modified Intent-to-Treat Population IMPACT: Time-to-First-Moderate or Severe COPD Exacerbation Analysis FF-UMEC-VI UMEC-VI FF-VI N 4151 2070 4134 Rate of moderate or severe exacerbations/year 0.91 1.21 1.07 RR for triple therapy (95% – 0.75 (0.70-0.81) P < .001 0.85 (0.80-0.90) P < .001 BGF GFF 18/9.6 BFF 320/9.6 N 2137 2120 2131 Rate of moderate or severe exacerbations/year 1.08 1.43 1.24 RR for BGF 320/18/9.6 (95% – 0.76 (0.69-0.83) P < .001 0.87 (0.79-0.95) P = .003 0 10 20 30 40 50 60 70 80 90 100 0 50 100 150 200 250 300 350 Patients who had a moderate or severe exacerbation (%) Days since randomization UMEC-VI FF-VI FF-UMEC-VI 0 10 20 30 40 50 60 70 80 90 100 0 10 20 30 40 50 Cumulative incidence Days since randomization GFF18/9.6 µg BFF320/9.6 µg BGF320/18/9.6 µg Severe exacerbations were defined as worsening symptoms of COPD that required inpatient hospitalization
- 14. 0 0.5 1 1.5 2 2.5 3 3.5 0 50 100 150 200 250 300 350 Days since randomization UMEC-VI FF-VI FF-UMEC-VI 0 0.5 1 1.5 2 2.5 3 0 10 20 30 40 50 Cumulative incidence Days since randomization GFF 18/9.6 µg BFF 320/9.6 µg BGF 320/18/9.6 µg ETHOS and IMPACT: Effect of Fixed-Dose Triple Therapy on Mortality IMPACT: Death from Any Cause On/Off Treatment (Including Additional Vital Status Data) ETHOS: All-Cause Deaths (Final Retrieved Dataset, ITT Population) Severe exacerbations were defined as worsening symptoms of COPD that required inpatient hospitalization. IMPACT: the primary outcome of reduction for the annual rate of moderate or severe COPD exacerbations with FF/UMEC/VI vs. FF/VI or UMEC/VI during treatment was met. ETHOS: the primary outcome of reduction for the annual rate of moderate or severe COPD exacerbations with BUD/GLY/FOR (2 doses of Bud 160µg or 360µg) vs. BUD/FOR or GLY/FOR during treatment was met. Lipson et al, 2020; Martinez et al, 2021. FF-UMEC-VI UMEC-VI FF-VI N 4151 2070 4134 RR for triple therapy (95% CI) (Including off-treatment) – 0.72 (0.53-0.99) P < .042 0.89 (0.67- 1.16) P < .387 BGF 320/18/9.6 GFF 18/9.6 BFF 320/9.6 N 2137 2120 2131 RR for BGF 320/18/9.6 (95% CI) (On and off treatment) – 0.51 (0.33-0.80) P = .0111 0.72 (0.44-1.16) P = .1721
- 15. IMPACT Subgroup Analysis Effects of Prior Exacerbation History and Eosinophil Count on Efficacy AECOPD, acute exacerbation of COPD; FF, fluticasone furoate; UMEC, umeclidinium; VI, vilanterol Halpin et al, 2020. Single moderate AECOPD 0.0 0.5 1.0 1.5 2.0 2.5 3.0 0 100 200 300 400 500 600 Blood eosinophil count at screening cells μg-1 Annual rate of exacerbations Severe AECOPD 0.0 0.5 1.0 1.5 2.0 2.5 3.0 0 100 200 300 400 500 600 Blood eosinophil count at screening cells μg-1 Annual rate of exacerbations Frequent moderate AECOPD 0.0 0.5 1.0 1.5 2.0 2.5 3.0 0 100 200 300 400 500 600 Blood eosinophil count at screening cells μg-1 Annual rate of exacerbations FF/UMEC/VI UMEC/VI FF/VI
- 16. Martinez et al, 2021. All-Cause Mortality in ETHOS Throughout the Study Strongly Suggests Benefit Is Not an ICS Withdrawal Effect
- 17. Non-Pharmacological Therapy of Stable COPD Patient Essential Recommended Local Guidelines A Smoking cessation Physical activity Flu and pneumococcal vaccination B, C, D Smoking cessation Pulmonary Physical activity Flu and pneumococcal vaccination www.goldcopd.org
- 18. Pulmonary Rehabilitation Improves Dyspnea 4 2 2 4 Behnke 2000a Cambach 1997 Favors Control Favors Treatment Goldstein 1994 Mean Difference (95% CI) 2.26 (1.34, 3.18) 1.20 (0.36, 2.04) 0.66 (0.12, 1.20) 0 Gosselink 2000 Griffiths 2000 Gell 1995 0.82 (0.17, 1.47) 1.18 (0.85, 1.51) 1.30 (0.64, 1.96) Gell 1998 Hernandez 2000 Simpson 1992 1.00 (0.20, 1.80) 0.78 (0.02, 1.54) 1.20 (0.37, 2.03) Singh 2003 Wijkstra 1994 Total 0.88 (0.35, 1.41) 0.90 (0.13, 1.67) 1.06 (0.85, 1.26) Lacasse et al, 2006.
- 19. Adherence to Inhaled Medications Is Low Patients with COPD often stop using their medication Abandon treatment soon after initiation1,2 Over 12 months, 50% of patients with COPD took <30% of doses3 Over 12 months, doses taken was higher for ICS/LABA at 49%4 90 days prior to COPD hospitalization only 41% filled COPD prescriptions5 1. Bender, 2014; 2. Wurst et al, 2014; 3. Davis et al, 2017; 4. Bogart et al, 2019; 5. Baker et al, 2014.
- 20. Adherence Requires Good Inhaler Technique Correct use of inhaled medication Prospective observational study of 244 patients with COPD followed for 1 month after hospital discharge Diskus controller with electronic recording device Only 6% had adherence >80% 51% of doses involved ≥1 critical technique error Sulaiman et al, 2017. Error type Mean/patient Low peak inspiratory flow 10.0 Multiple inhalations 4.8 Multiple errors 2.3 Blister present, no inhale detected 1.5 Exhaling into the mouthpiece 1.1 Others 1.0 Total 20.7
- 21. Proper Inhaler Technique 1. Metered dose inhaler with/without spacer http://www.cdc.gov/asthma/inhaler_video 2. All inhaler types https://www.copdfoundation.org/Learn- More/Educational-Materials- Resources/Educational-Video-Series.aspx
- 22. Thank You for Joining Us! We are excited to see the impact of this educational activity on patient care in COPD In 4 weeks, you will receive a follow-up survey to see if you’ve been able to implement any of your intended changes as a result of what you learned today If you have any questions, send us an email: contact@cmespark.com
- 23. References Agusti A, Fabbri LM, Singh D, et al (2018). Inhaled corticosteroids in COPD: friend or foe? Eur Respir J. 2018;52(6):1801219. DOI:10.1183/13993003.01219-2018 Baker CL, Zou KH & Su J (2014). Long-acting bronchodilator use after hospitalization for COPD: an observational study of health insurance claims data. Int J COPD. 9:431-39. DOI:10.2147/COPD.S59322 Bender BG (2014). Nonadherence in chronic obstructive pulmonary disease patients: what do we know and what should we do next? Curr Opin Pulm Med. 20(2):132-37. DOI:10.1097/MCP.0000000000000027 Bogart M, Stanford RH, Laliberté F, et al (2019). Medication adherence and persistence in chronic obstructive pulmonary disease patients receiving triple therapy in a USA commercially insured population. Int J COPD. 14:343-52. DOI:10.2147/COPD.S184653 Davis JR, Wu B, Kern DM, et al (2017). Impact of nonadherence to inhaled corticosteroid/LABA therapy on COPD exacerbation rates and healthcare costs in a commercially insured US Population. Am Health Drug Benefits. 10(2):92-102. Halpin DMG, Dransfield MT, Han MK, et al (2020). The effect of exacerbation history on outcomes in the IMPACT trial. Eur Respir J. 55(5):1901921. DOI:10.1183/13993003.01921-2019 Lacasse Y, Goldstein R, Lasserson TJ & Martin S (2006). Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 18(4):CD003793. Lipson DA, Barnhart F, Brealey N, et al (2018). once-daily single-inhaler triple versus dual therapy in patients with COPD. N Engl J Med. 378:1671-80. DOI:10.1056/NEJMoa1713901 Lipson DA, Crim C, Criner GJ, et al (2020). Reduction in all-cause mortality with fluticasone furoate/umeclidinium/vilanterol in patients with chronic obstructive pulmonary disease. Am J Respir Crit Car Med. 201(12):1508-16. DOI:10.1164/rccm.201911- 2207OC
- 24. Martinez FJ, Rabe KF, Ferguson GT, et al (2021). Reduced all-cause mortality in the ETHOS trial of budesonide/glycopyrrolate/formoterol for chronic obstructive pulmonary disease. a randomized, double-blind, multicenter, parallel- group study. Am J Respir Crit Car Med. 203(5):553-64. DOI:10.1164/rccm.202006-2618OC Rabe KF, Martinez FJ, Ferguson GT, et al (2020). Triple inhaled therapy at two glucocorticoid doses in moderate-to-very-severe COPD. N Engl J Med. 383:35-48. DOI:10.1056/NEJMoa1916046 Sulaiman I, Cushen B, Greene G, et al (2017). Objective assessment of adherence to inhalers by patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 195(10):1333-43. DOI:10.1164/rccm.201604-0733OC Wurst KE, St Laurent S, Mullerova H & Davis KJ (2014). Characteristics of patients with COPD newly prescribed a long-acting bronchodilator: a retrospective cohort study. Int J COPD. 9:1021-31. DOI:10.2147/COPD.S58258 References
Editor's Notes
- #10: The figure suggests escalation and de-escalation strategies based on available efficacy as well as safety data. The response to treatment escalation should always be reviewed, and de-escalation should be considered if there is a lack of clinical benefit and/or side effects occur. De-escalation may also be considered in COPD patients receiving treatment who return with resolution of some symptoms that subsequently may require less therapy. Patients, in whom treatment modification is considered, in particular de-escalation, should be undertaken under close medical supervision. Treatment escalation has not been systematically tested; trials of de-escalation are also limited and only include ICS.
- #14: Primary endpoint for both
- #15: Reduced mortality in both
- #18: Note the recommendation of smoking cessation, physical activity and vaccination for all and pulmonary rehabilitation for symptomatic patients
- #19: Pulmonary rehabilitation is intervention with most reproducible effect on improving health status (CRQ) Background The widespread application of pulmonary rehabilitation in chronic obstructive pulmonary disease (COPD) should be preceded by demonstrable improvements in function attributable to the programs. This review updates that reported in 2001. Objectives To determine the impact of rehabilitation on health-related quality of life (QoL) and exercise capacity in patients with COPD. Search strategy We identified additional RCTs from the Cochrane Airways Group Specialised Register. Searches were current as of July 2004. Selection criteria We selected RCTs of rehabilitation in patients with COPD in which quality of life (QoL) and/or functional (FEC) or maximal (MEC) exercise capacity were measured. Rehabilitation was defined as exercise training for at least four weeks with or without education and/or psychological support. Control groups received conventional community care without rehabilitation. Data collection and analysis We calculated weighted mean differences (WMD) using a random-effects model. We requested missing data from the authors of the primary study. Main results We included the 23 randomized controlled trials (RCTs) in the 2001 Cochrane review. Eight additional RCTs (for a total of 31) met the inclusion criteria. We found statistically significant improvements for all the outcomes. In four important domains of QoL (Chronic Respiratory Questionnaire scores for Dyspnea, Fatigue, Emotional function and Mastery), the effect was larger than the minimal clinically important difference of 0.5 units (for example: Dyspnoea score: WMD 1.0 units; 95% confidence interval: 0.8 to 1.3 units; n = 12 trials). Statistically significant improvements were noted in two of the three domains of the St. Georges Respiratory Questionnaire. For FEC and MEC, the effect was small and slightly below the threshold of clinical significance for the six-minute walking distance (WMD: 48 meters; 95% CI: 32 to 65; n = 16 trials).