11/27/18. Challenges in Pulmonary and Critical Care: COPD So Much is New! Faculty. Disclosures

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1 Challenges in Pulmonary and Critical Care: 2018 COPD So Much is New! 1 Faculty Anas Hadeh, MD, FCCP Director, Pulmonary and Critical Care Medicine Fellowship Program Affiliate Assistant Professor of Clinical Biomedical Science FAU Charles E. Schmidt College of Medicine Cleveland Clinic Florida Weston, FL 2 Disclosures Anas Hadeh, MD, FCCP serves as a speaker trainer and on the advisory board for Insmed. 3 1

2 Learning Objectives 1. Tailor COPD pharmacotherapy according to current recommended therapeutic strategies which incorporate unique patient needs and characteristics. 2. Discuss strategies to facilitate the appropriate use of inhaled therapies for COPD, including the importance of proper inhaler technique. 3. Recognize appropriate strategies to prevent and manage COPD exacerbations and to provide transitions of care post hospitalization. 4. Collaborate with members of interprofessional health care team to create an effective patient-centered, COPD chronic disease management program. 4 PRE-TEST QUESTIONS 5 5 Pre-test ARS Question 1 Pre-C1: How confident are you in your ability to select appropriate inhaled therapies for patients with COPD, based on disease severity and patient characteristics? 1. Not at all confident 2. Slightly confident 3. Moderately confident 4. Pretty much confident 5. Very confident 6 2

3 Pre-test ARS Question 2 Pre-C2: What COPD phenotype will benefit the most from Phosphodiesterase-4 Inhibitors? 1. A 75 y/o male with a FEV1 of 30 %, severe dyspnea, upper lobes emphysema but no exacerbations last year. 2. A 60 y/o female with productive cough, FEV1 of 50% and 2 exacerbations last year 3. A 55 y/o male with FEV1 of 35%, dry cough and 3 exacerbations last year. 4. A 69 y/o female with Asthma-COPD overlap,fev1 of 60% and ICS/LABA dependence. 7 Pre-test ARS Question 3 Pre-C3: A 75 y/o male COPD patient with FEV1 of 45%, dyspnea with minimal activity and dry cough. He is on Tiotropium and combination Fluticasone /Salmeterol 250/50. He had one exacerbation last year that was treated as an outpatient. Your next step is: 1. Add Roflumilast 2. Add Azithromycin 3. Switch him to single inhaler triple therapy 4. D/C all inhalers and start a single LAMA/LABA 5. Increase Fluticasone/Salmeterol to 500/50 8 Pre-test ARS Question 4 Pre-C4: Which one of these delivery devices usually requires good peak inspiratory flow? 1. DPIs (Dry Powder Inhalers) 2. pmdis (pressurized Metered Dose Inhalers) 3. SMIs (Soft Mist Inhalers) 4. Nebulizers 9 3

4 Pre-test ARS Question 5 Pre-C5: According to the GOLD 2017 Guidelines chronic disease management recommendations, you should monitor the following at EACH visit EXCEPT: 1. Dosages of prescribed medications 2. Adherence to medication regimen 3. Inhaler technique 4. Quantitative evaluation of lung function with Spirometry 10 Global Strategy for Diagnosis, Management and Prevention of COPD Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases. Exacerbations and comorbidities contribute to the overall severity in individual patients Global Initiative for Chronic Obstructive Lung Disease 11 Risk Factors for COPD Smoking accounts for 80% of all COPD diagnosis. Other etiologies: Second hand smoke Environmental Exposures Cooking or heating with wood, peat, dung Occupational Exposures Undertreated asthma Genetics 12 4

5 Diagnosis of COPD SYMPTOMS dyspnea chronic cough sputum production EXPOSURE TO RISK FACTORS tobacco (ETS) occupation indoor/outdoor pollution SPIROMETRY: Required to establish diagnosis 13 Spirometry Global Initiative for Chronic Obstructive Lung Disease Assessment of Airflow Limitation: Spirometry A post-bronchodilator FEV 1/FVC < 0.70 confirms the presence of airflow limitation. Where possible, values should be compared to age-related normal values to avoid overdiagnosis of COPD in the elderly. 5th percentile LLN (lower limit of normal) 15 5

6 16 Haroon, et al. Int J COPD 2015;10(1):1711 GOLD 2017 Strategy Recommends Multidimensional Assessment of COPD First Step: Assess Risk: Ask about Exacerbation Exacerbation 2/ One or more Hospitalizations Exacerbation <2 Second Step: Ask about Symptoms Use Scales mmrc 0-1/CAT <10 Less Symptoms mmrc 2-4/CAT 10 More Symptoms 17 The Global Initiative for Obstructive Lung Disease 2017 Report. Combined Assessment of COPD 2x2 table (C) (A) (D) (B) > 2 1 Risk (Exacerbation history) 1 0 mmrc 0-1 CAT < 10 mmrc > 2 CAT > 10 Symptoms (mmrc or CAT score)) 18 6

7 Treatment Guidelines 19 Manage Stable COPD: Goals of Therapy Quality of life goals: Relieve symptoms Improve exercise tolerance Improve health status Natural history of the disease: Prevent disease progression Prevent and treat exacerbations Reduce mortality 20 Pharmacotherapy Reduce COPD symptoms, reduce the frequency and severity of exacerbations, and improve health status and exercise tolerance. None of the existing medications for COPD has been shown conclusively to modify the long-term decline in lung function. 21 7

8 SABAs and SAMAs 22 LAMAs LABAs 23 LABA/LAMA 24 8

9 LABAs / ICS 25 LABA/LAMA/ICS 26 Adverse Effects Of Therapy ß2- Anticholinergics 3 Inhaled Roflumilast 6 Azithromycin 7, Agonists 1,2,4 Glucocorticoids 5 8 Tremors Dry Mouth Dysphonia Diarrhea Antimicrobial resistance Palpitations Urinary retention Thrush Weight decrease Hypokalemia Glaucoma Systemic Effects: bruising, bone density, cataract Nausea Arrhythmias Arrythmias Pneumonia Headache Depression Hearing decrease Arrhythmia 1. Decramer ML, et al. Int J COPD. 2013;8: Wilchesky M, et al. Chest 2012; 142:305-11; 3. Rennard SI. Lancet. 2004;364: Singh S, et al. Thorax 2013; 68: 114-6; 5. Saag et al Upto Date 2011; 6. Calverley, PMA et al. Lancet 2009; 374: ; 7. Albert RK, et al. N Eng J Med. 2011;365: ; 8. Ray WA et al. NEJM. 2012;366(20):

10 GOLD 2017 Strategy Individualization of Treatment Each pharmacologic treatment regimen should be individualized and guided by the severity of symptoms, risk of exacerbations, side-effects, comorbidities, drug availability and costs, and the patient s response, preference and ability to use various drug delivery devices. GOLD, Global Initiative for Chronic Obstructive Lung Disease. Vogelmeier CF, et al. Am J Respir Crit Care Med. 2017;195: A 57 y/o male with DM, 35 PY smoking and confirmed COPD, mmrc score of 3, minimal chronic sputum production and no bronchitis over the past year Current COPD medications include short-acting beta-agonist prn and umeclidinium inhaled once daily. What therapeutic option would you recommend for him? 1. Add a SAMA 2. Add a LABA 3. Add an ICS/LABA Polling Question 4. Add roflumilast after ophthalmology evaluation 29 GOLD therapeutic recommendations Group C LAMA + LABA LABA + ICS Group D Consider roflumilast if FEV1 < 50% pred and patient has chronic bronchitis Consider macrolide Further Exacerbation(s) LAMA Further Exacerbation(s) Further Exacerbation(s) LAMA LAMA + LABA + ICS LAMA + LABA Persistent symptoms/further exacerbations LABA + ICS Group A Continue, stop or try alternative class of bronchodilator Group B LAMA + LABA Evaluate effect A bronchodilator Persistent symptoms A long-acting bronchodilator (LABA or LAMA) 30 The Global Initiative for Obstructive Lung Disease 2017 Report. 10

11 GOLD Therapeutic Recommendations Group B LAMA + LABA Persistent symptoms A long-acting bronchodilator (LABA or LAMA) 31 The Global Initiative for Obstructive Lung Disease 2017 Report. A 57 y/o male with DM, 35 PY smoking and confirmed COPD, mmrc score of 1, minimal chronic sputum production and 3 bronchitis over the past year Current COPD medications include short-acting beta-agonist prn and umeclidinium inhaled once daily. What therapeutic option would you recommend for him? 1. Add a LAMA 2. Add a LABA 3. Add an ICS/LABA Polling Question 4. Add roflumilast after ophthalmology evaluation 32 GOLD therapeutic recommendations Group C LAMA + LABA LABA + ICS Group D Consider roflumilast if FEV1 < 50% pred and patient has chronic bronchitis Consider macrolide Further Exacerbation(s) LAMA Further Exacerbation(s) Further Exacerbation(s) LAMA LAMA + LABA + ICS LAMA + LABA Persistent symptoms/further exacerbations LABA + ICS Group A Continue, stop or try alternative class of bronchodilator Group B LAMA + LABA Evaluate effect A bronchodilator Persistent symptoms A long-acting bronchodilator (LABA or LAMA) 33 The Global Initiative for Obstructive Lung Disease 2017 Report. 11

12 GOLD Therapeutic Recommendations Group C LAMA + LABA LABA + ICS Further Exacerbation(s) LAMA 34 The Global Initiative for Obstructive Lung Disease 2017 Report. ICS/LABA vs. LABA/LAMA for exacerbations 35 Wedzicha JA, et al. N Engl J Med 2016; 374: Inhaled Steroids have Serious Adverse Effects Pneumonia Osteoporosis Oral candidiasis Dysphonia Easy bruising Cataracts Diabetes Mycobacteria ICS package inserts 36 12

13 Pneumonia with Inhaled Steroids Many studies show a 50% - 100% increase in pneumonia with inhaled steroids 1, 2, 3 May not occur with budesonide / formoterol 4 Associated with ICS dose and potency Associated with severe airflow limitation, smokers, age >55, prior AECOPD or pneumonia, BMI <25, worse mmrc dyspnea GOLD 2018: Regular treatment with ICS increases the risk of pneumonia (Evidence A) 1. Wedzicha. AJRCCM IMPACT study. NEJM Crim. Torch study. ERJ Cochrane review, SUNSET 26-week study; remove ICS from triple Rx 1,053 patients: < 1 AECOPD in prior year, FEV % Randomized to continued triple therapy or LABA/LAMA Triple therapy tiotropium/salmeterol/fluticasone 1000 Dual bronchodilator indacaterol/glycopyrronium Outcome: noninferiority of ICS withdrawal on FEV1 trough Secondary outcome: AECOPD, TDI, SGRQ Chapman KR. AJRCCM. 2018; 198: Significant small 26 ml decrease in FEV 1 after ICS withdrawal Chapman KR. AJRCCM. 2018; 198:

14 2,485 patients with history of AECOPD, FEV1 < 50% Triple therapy tiotropium, salmeterol, fluticasone 1000 Randomized to continued triple therapy or Step-wise ICS withdrawal over 18 weeks 40 Magnussen H, et al. New Engl J Med. 2014; 371: ICS Withdrawal: WISDOM Trial ICS withdrawal did not change time to first COPD exacerbation Magnussen H, et al. New Engl J Med. 2014; 371: ICS Withdrawal: WISDOM Trial ICS withdrawal reduced FEV1: 38 ml at 18 weeks 43 ml at 52 weeks Magnussen H, et al. New Engl J Med. 2014; 371:

15 Should an Attempt be Made to Withdraw Inhaled Corticosteroids in all Patients with Stable GOLD 3 (30% FEV1 < 50% Predicted) COPD? 43 Chalmers, CHEST , DOI: ( /j.chest ) Polling Question 63 y/o male was prescribed therapy with a combination agent, LABA/LAMA. Over the past 6 months he had another episode of bronchitis treated at the hospital with antibiotics, steroids burst. He does not have chronic sputum production. What option would you recommend for him at this point? 1. Order PET scan 2. Add an ICS (LAMA + LABA/ICS) 3. Add theophylline 4. Add O2 5. Add roflumilast 44 Group D Consider roflumilast if FEV1 < 50% pred and patient has chronic bronchitis Further Exacerbation(s) Further Exacerbation(s) GOLD Therapeutic Recommendations LAMA + LABA + ICS Consider macrolide Persistent symptoms/further exacerbations LAMA LAMA + LABA LABA + ICS 45 The Global Initiative for Obstructive Lung Disease 2017 Report. 15

16 Randomized 1-year trial Triple Rx (fluticasone 100 ug, umeclidinium, vilanterol) LABA/LAMA (umeclidinium, vilanterol) LABA/ICS (fluticasone, vilanterol) 10,355 COPD patients w/copd Assessment Test > 10 FEV1 < 50% pred + > 1 AECOPD in the past year FEV % pred + > 2 moderate or 1 severe AECOPD in the past year 46 N Engl J Med 2018;378: Triple vs. Dual Therapy: IMPACT 15% 25% 47 Lipson. NEJM 2018;378:1671 Macrolides 48 Albert RK et al. N Engl J Med 2011;365:

17 Phosphodiesterase-4 Inhibitors Roflumilast In patients with severe and very severe COPD (GOLD 3 and 4) and a history of exacerbations and chronic bronchitis = Group D 17% reduction in exacerbation Calverley PM Lancet Aug 29;374(9691): Delivery Device Considerations 50 Numerous Inhaler Devices can be a Challenge No single inhaler will satisfy the needs of all patients à 28-68% of patients do not use inhalers correctly à A sub-optimal technique can result in decreased lung delivery and potentially reduced efficacy 3 The proliferation of inhalation devices in the market can result in confusion for clinicians, nurses, respiratory therapists and patients 1 à Each available device require specific inhalation techniques 1 Studies have demonstrated lack of knowledge in the use of devices by healthcare professionals 2 à 39-67% of HCPs are unable to adequately perform or describe inhalation techniques 4 Clinicians need to select the right inhaler for each patient à knowing each product s characteristics is key 4 1. Anna Murphy, SIMPLE Baverstock et al. Thorax, 2010;65:A117-A Labiris et al. Br J Clin Pharmacol, 2003;56, Lewis RM, Fink JB. Resp Crit Care Clin North Am 2001;7:

18 Delivery Device Considerations pmdis Requires coordination between actuation and inhalation (which can be eased when used in conjunction with a spacer, or by using a breathactuated pmdi) DPIs Varies; they are generally breathactuated and do not require coordination between actuation and inhalation SMIs Requires assembly and coordination between actuation and inhalation Nebulizers No specific breathing techniques have to be taught for using nebulizers Dhand et al Cleveland Clinic Journal of Medicine. doi: /ccjm.85.s Delivery Device Considerations Dhand et al Cleveland Clinic Journal of Medicine. doi: /ccjm.85.s Chronic Disease Management 54 18

19 Monitoring and Follow-up Pharmacotherapy and other medical treatment In order to adjust therapy appropriately as the disease progresses, each follow-up visit should include a discussion of the current therapeutic regimen. Monitoring should focus on: Dosages of prescribed medications Adherence to the regimen Inhaler technique Effectiveness of the current regime Side effects Treatment modifications should be recommended Global Initiative for Chronic Obstructive Lung Disease Adherence to Inhaled Medications is Poor Among COPD Patients Prospective study of 244 COPD patients (160 post exacerbation) Electronic monitoring of compliance with diskus device: Mean adherence was 22.6% Adherence > 80 in only 6% 56 Sulaiman I, et al. Am J Respir Crit Care Med 2016; 195: Adherence Decreases and Inhaler Misuse Increases with Time 57 Melani AS & Paleari D. COPD 2016; 13:

20 Optimizing Acute Care Appropriate Antibiotic treatment Appropriate Steroid use Appropriate Maintenance Medication on Discharge Smoking Cessation Patient Education Disease Process Danger Signals Inhaler Technique Oxygen use 58 Optimizing Transition of Care Discharge Planning:? Need for home care Appropriate MD follow up within 7-10 days Consider risk of co-morbidities for readmission Telephonic assessments at periodic intervals Remote Assessment of symptoms, oxygenation etc. (future of telemedicine) 59 Education and Self-Management Self-management education and coaching by healthcare professionals should be a major component of the Chronic Care Model within the context of the healthcare delivery system. The aim of self-management education is to motivate, engage and coach the patients to positively adapt their health behavior(s) and develop skills to better manage their disease Global Initiative for Chronic Obstructive Lung Disease 60 20

21 61 Optimizing Transition of Care Intervention group patients received a single 1- to 1.5-hour education session, an action plan for selftreatment of exacerbations, and monthly follow-up calls from a case manager. Am J Respir Crit Care Med, 62 Am J Respir Crit Care Med,

22 POST-TEST QUESTIONS 64 Post-test ARS Question 1 Post-C1: How confident are you in your ability to select appropriate inhaled therapies for patients with COPD, based on disease severity and patient characteristics? 1. Not at all confident 2. Slightly confident 3. Moderately confident 4. Pretty much confident 5. Very confident 65 Post-test ARS Question 2 Post-C2: What COPD phenotype will benefit the most from Phosphodiesterase-4 Inhibitors? 1. A 75 y/o male with a FEV1 of 30%, severe dyspnea, upper lobes emphysema but no exacerbations last year. 2. A 60 y/o female with productive cough, FEV1 of 50% and 2 exacerbations last year 3. A 55 y/o male with FEV1 of 35%, dry cough and 3 exacerbations last year. 4. A 69 y/o female with Asthma-COPD overlap,fev1 of 60% and ICS/LABA dependence

23 Post-test ARS Question 3 Post-C3: A 75 y/o male COPD patient with FEV1 of 45%, dyspnea with minimal activity and dry cough. He is on Tiotropium and combination Fluticasone /Salmeterol 250/50. He had one exacerbation last year that was treated as an outpatient. Your next step is: 1. Add Roflumilast 2. Add Azithromycin 3. Switch him to single inhaler triple therapy 4. D/C all inhalers and start a single LAMA/LABA 5. Increase Fluticasone/Salmeterol to 500/50 67 Post-test ARS Question 4 Post-C4: Which one of these delivery devices usually requires good peak inspiratory flow? 1. DPIs (Dry Powder Inhalers) 2. pmdis (pressurized Metered Dose Inhalers) 3. SMIs (Soft Mist Inhalers) 4. Nebulizers 68 Post-test ARS Question 5 Post-C5: According to the GOLD 2017 Guidelines chronic disease management recommendations, you should monitor the following at EACH visit EXCEPT: 1. Dosages of prescribed medications 2. Adherence to medication regimen 3. Inhaler technique 4. Quantitative evaluation of lung function with Spirometry 69 23