Disclosure and Conflict of Interest 8/15/2017. Pharmacist Objectives. At the conclusion of this program, the pharmacist will be able to:

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1 Digging for GOLD Rebecca Young, PharmD, BCACP, Roosevelt University College of Pharmacy Assistant Professor of Clinical Sciences Practice Site Advocate Medical Group-Nesset Pavilion Disclosure and Conflict of Interest Pharmacist Objectives Dr. Young declares no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings and honoraria. At the conclusion of this program, the pharmacist will be able to: Compare and contrast the important changes to the GOLD guidelines, including categorization of COPD, nonpharmacologic and pharmacologic treatment for COPD. Describe recent literature regarding COPD management that contributed to GOLD guideline changes. Develop a treatment plan for a patient, given a patient case and current guideline recommendations. 1

2 Pre-Test Question #1 Pre-Test Question #2 JT is a 58 yo male who was diagnosed with COPD 2 years ago. He presents to his PCP for a regular visit. He had one admission for a COPD exacerbation in the last year and his spirometry showed FEV1 of 55% predicted. His CAT score was 12. What COPD category is JT? A. A B. B C. C D. D What do you recommend for JT s COPD? A. LABA B. LAMA C. LAMA + LABA D. LABA + ICS Pre-Test Question #3 Which trial looked at COPD exacerbations between a LABA+ICS compared to LABA+LAMA? A. TORCH B. FLAME C. SMART D. UPLIFT Let s Review what is 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 alvelolar abnormalities usually caused by significant exposure to noxious particles or gases. 2

3 Symptoms Cough Sputum Dyspnea Risk factors COPD Time to get some GOLD Spirometry FEV 1 /FVC<0. 70 Williams DM and Bourdet SV. Chapter 16. Chronic Obstructive Pulmonary Disease. In: DiPiro JT, et al (eds) Pharmacotherapy: A pathophysiologic Approach. 9 th ed. New York: McGraw-Hill; P GOLD Classification Symptoms Assessment Classification of airflow limitation severity in COPD (based on postbronchodilator FEV 1) In patients with FEV 1 /FVC < 0.70 GOLD 1 Mild FEV 1 80% predicted GOLD 2 Moderate 50 % FEV 1 < 80% predicted GOLD 3 Severe 30 % FEV 1 < 50% predicted GOLD 4 Very Severe FEV 1 < 30% predicted Modified British Medical Research Council (mmrc) COPD Assessment Test (CAT) 3

4 Modified MRC Dyspnea Scale COPD Assessment Test (CAT) Modified MRC Dyspnea scale mmrc Grade 0 mmrc Grade 1 mmrc Grade 2 mmrc Grade 3 mmrc Grade 4 I only get breathless with strenuous exercise. I get short of breath when hurrying on the level or walking up a slight hill. I walk slower than people of the same age on the level because of breathlessness, or I have to stop for breath when walking on my own pace on the level. I stop for breath after walking about 100 meters or after a few minutes on the level. I am too breathless to leave the house or I am breathless when dressing or undressing. OLD Guidelines Assessment 2017 Guideline Assessment Exacerbation History 2 or 1 leading to a hospital admission 0 or 1 (not hospital admission) (C) (A) (D) (B) mmrc 0-1 CAT <10 mmrc 2 CAT 10 Symptoms Global strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD)

5 Post Test Question #1 JT is a 58 yo male who was diagnosed with COPD 2 years ago. He presents to his PCP for a regular visit. He had one admission for a COPD exacerbation in the last year and his spirometry showed FEV1 of 55% predicted. His CAT score was 12. What does GOLD say about treatment What COPD category is JT? A. A B. B C. C D. D Non-pharmacologic Treatment Smoking and Lung Function Fletcher C et al. Br Med J. 1977; 1(6077):

6 Exercise All patients Pulmonary rehab programs Patient s benefit from rehabilitation Maintain physical activity Improves exercise tolerance & health status Decreases dyspnea and fatigue Optimum time is 6-8 weeks Long-Term Oxygen Therapy (LTOT) Administration >15 hours per day Patients with chronic respiratory failure Increases survival in patients with severe resting hypoxemia Conditions for LTOT: Rest PaO 2 < 55 mm Hg or SaO 2 < 88% with or without hypercapnia 2 x s in 3 week period Resting PaO mm Hg or SaO 2 of 88% with evidence of peripheral edema, polycythema (hematocrit >55%), or pulmonary hypertension Re-evaluate days Reduce risk factors for exacerbations Influenza Common complication in COPD Can reduce serious illness and death Yearly Pneumococcal Recommend pneumococcal for 65 years PCV13 Reduces bacteremia and serious invasive pneumococcal disease PPSV23 for <65 w/ comorbid conditions Shown to reduce CAP in <65 w/ FEV1 < 40% or w/ comorbidities How do we choose therapy? 6

7 Patient Group Pharmacologic Treatment Recommended First Choice Alternative Choice Other Possible treatments Pharmacologic Treatment A B C D SABA PRN or SAA PRN LAA or LABA ICS + LABA or LAA ICS + LABA and/or LAA SABA: Short acting β 2 agonist SAA: Short acting anticholinergic LABA: Long acting β 2 agonist LAA, or LABA, or SABA and SAA LAA and LABA LAA and LABA, or LAA and PDE-4 inh, or LABA and PDE-4 inh ICS + LABA and LAA, or ICS + LABA and PDE-4 inh, or LAA and LABA, or LAA and PDE-4 inh Theophylline SABA and/or SAA Theophylline SABA and/or SAA Theophylline SABA and/or SAA Theophylline N-acetylcysteine LAA: Long acting anticholinergic ICS: Inhaled corticosteroid PDE-4 inh: Phosphodiesterase- 4 inhibitor Global strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) Continue, stop, or change bronchodilator Assess Bronchodilator Pharmacologic Treatment Pharmacologic Treatment LAMA + LABA Symptoms LAMA or LABA LAMA + LABA Continued Exacerbation(s) LAMA LABA + ICS 7

8 Pharmacologic Treatment Post-Test Question #2 Roflumilast if FEV 1 < 50% predicted & Chronic bronchitis Exacerbation(s) Macrolide (former smokers) What do you recommend for JT s COPD? LAMA Exacerbation(s) LAMA + LABA + ICS LAMA + LABA Persistent Sx/Exacerbation(s) LABA + ICS A. LABA B. LAMA C. LAMA + LABA D. LABA + ICS TORCH Trial Why are they recommending less use of ICS in COPD? Purpose: To determine if there is a reduction in all-cause mortality in COPD patients treated with salmeterol/fluticasone Methods: 3 yr, multicenter, randomized, double-blind, placebo controlled Placebo Salmeterol 50 mcg BID Fluticasone 500 mcg BID Fluticasone/salmeterol 500/50 mcg BID Calverley PMA, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease (TORCH). N Engl J Med 2007;356: :

9 TORCH Trial 6,184 patients randomized Characteristics: Mean age 65 yrs, 75% males, post bronchodilator FEV 1 44%, 43% current smokers, 57% with exacerbation in prior year Results: Primary Outcome: Mortality at 3 year Placebo 15.2% 12.3% Salmeterol 13.5% 13.3% Fluticasone 16% 18.3% Combo 12.6% 19.6% Safety: Pneumonia FLAME Trial Purpose: To determine if indacaterol-glycopyrronium would be noninferior to salmeterol-fluticasone in reducing COPD exacerbation rates Methods: 52 week, multicenter, randomized, double-blind, double dummy, parallel-group, non-inferiority trial Indacacterol /glycopyrronium 110 mcg/50 mcg Salmeterol/fluticasone 500 mcg/50 mcg Calverley PMA, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease (TORCH). N Engl J Med 2007;356: Wedzicha JA, Banerji D, Chapman KR, et. al. Indaceterol-Glycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med ;22: FLAME Trial 3362 patients underwent randomization Patient Characteristics: 65 year old 75% males 56% on ICS 40% current smokers 75% in group D Primary outcome: Noninferiority: 4.03 (salmeterol-fluticasone) vs 3.59 (indacaterol-glycopyrronium) RR 0.89 (0.83,0.96) p=0.003 Post-Test Question #3 Which trial looked at COPD exacerbations between a LABA+ICS compared to LABA+LAMA? A. TORCH B. FLAME C. SMART D. UPLIFT Wedzicha JA, Banerji D, Chapman KR, et. al. Indaceterol-Glycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med ;22:

10 COPD Exacerbation What about exacerbations? Triggered by respiratory infections and environmental factors Last 7-10 days Cardinal Symptoms: Worsening dyspnea Increased sputum purulence Increased sputum volume COPD Exacerbation Treatment Factors Favoring Hospitalization Short Acting Bronchodilator Mild and Moderate Corticosteroids Moderate Prednisone 40 mg for 5-7 days Antibiotics All 3 cardinal symptoms 2 cardinal symptoms w/ one being increased sputum purulence Choose based on local resistance Use for 5-7 days Respiratory support Sudden worsening of dyspnea, RR, SpO2, confusion, drowsiness Acute respiratory failure New physical signs (cyanosis, peripheral edema) Failure of exacerbation responding to initial management Comorbidities Lack of home support 10

11 Take Home Points Resources & References Spirometry is not used in assessing COPD patients Nonpharmacologic treatments play a role in management of COPD Use of ICS has changed in treatment of COPD Future trials may answer questions Most exacerbations are managed on an outpatient basis and SABA s are used Global strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) Williams DM and Bourdet SV. Chapter 16. Chronic Obstructive Pulmonary Disease. In: DiPiro JT, et al (eds) Pharmacotherapy: A pathophysiologic Approach. 9 th ed. New York: McGraw-Hill; P Fletcher C et al. Br Med J. 1977; 1(6077): Calverley PMA, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease (TORCH). N Engl J Med 2007;356: : Wedzicha JA, Banerji D, Chapman KR, et. al. Indaceterol-Glycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med ;22: Speaker Contact Information Rebecca Young, PharmD, BCACP Roosevelt University College of Pharmacy ryoung14@roosevelt.edu 11