Tools for Diagnosis, Assessment, and Management of Chronic Obstructive Pulmonary Disease in Clinical Practice
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1 Tools for Diagnosis, Assessment, and Management of Chronic Obstructive Disease in Clinical Practice February 6, 2014 Fort Lauderdale, Florida Educational Partner:
2 Session 4: Tools for Diagnosis, Assessment, and Management of Chronic Obstructive Disease in Clinical Practice Learning Objectives 1. Utilize recommendations, such as those of the Global Initiative for chronic Obstructive Disease (GOLD) and the Chronic Obstructive Disease (COPD) Foundation, for diagnosis of COPD, including use of spirometry and evaluation of symptoms. 2. Evaluate and differentiate between standard COPD therapies for decreasing exacerbations and improving symptoms and other outcomes. 3. Integrate recently approved agents into the COPD treatment armamentarium through evidence-based decision making. Faculty Jill Ohar, MD Professor,, Critical Care, Allergy, and Immunologic Medicine Center for Genomics and Personalized Medicine Research Comprehensive Cancer Center Center for Worker Health Director, Respiratory Therapy Wake Forest Baptist Health Winston-Salem, North Carolina Dr Jill Ohar earned her Bachelor of Science degree, graduating magna cum laude, from Muhlenberg College, Allentown, Pennsylvania, and her medical degree from Medical College of Pennsylvania, Philadelphia. Her postdoctoral training included an internship in obstetrics/gynecology at the Medical College of Pennsylvania and a residency in medicine at Medical College of Virginia, Richmond; where she completed a subsequent clinical fellowship in pulmonary diseases. She has served on the faculty at Saint Louis University and is currently a tenured professor at Wake Forest University School of Medicine. Dr Ohar is a clinical investigator and the author or coauthor of numerous journal articles, reviews, abstracts, and book chapters. Her work has been published in journals such as American Journal of Respiratory and Critical Care Medicine, Journal of the American Medical Society, and Chest. Her current research interests focus on the diagnosis and delivery of care to COPD patients, with education as a significant part of this initiative. She has lectured on COPD nationally and internationally, including at the American Thoracic Society s International Meeting, the annual meeting of the American College of Physicians, and Academy of Family Physicians, Yale University, and the Jagiellonian University in Krakow, Poland. Dr Ohar is a member of the American College of Physicians, the American Thoracic Society, and a fellow of the American College of Chest Physicians, where she serves as governor of the North Carolina chapter. Fernando J. Martinez, MD, MS Professor, Department of Internal Medicine Director, Diagnostic Services University of Michigan Ann Arbor, Michigan Dr Fernando Martinez is professor of internal medicine and associate chief for clinical research in the division of pulmonary and critical care medicine at the University of Michigan Health System. In addition, he is medical director of pulmonary diagnostic services and comedical director of lung transplantation at the University of Michigan, Ann Arbor. After graduating from the University of Florida College of Medicine, he completed his residency in internal medicine at
3 Beth Israel Hospital, New York City, and his fellowship in pulmonary medicine at the Boston University Center, Massachusetts. Dr Martinez s main research interests include COPD, interstitial lung disease, lung transplantation, and lung volume reduction. He is currently a member of numerous societies, including the American Thoracic Society, the European Respiratory Society, American College of Chest Physicians, and the Fleischner Society. He was previously a member of the American Thoracic Society committees, which generated guidelines for the management of COPD, respiratory infections, and cardiopulmonary exercise testing, and is the former chair of the clinical problems assembly of the American Thoracic Society. He is currently a member of the GOLD Science Committee. Dr Martinez sits on a number of editorial boards, including the Journal of COPD and the American Journal of Respiratory and Critical Care Medicine. Faculty Financial Disclosure Statements The presenting faculty reports the following: Jill Ohar, MD, serves on the advisory board for AstraZeneca. Fernando J. Martinez, MD, MS, is a consultant for Bayer, Forest Laboratories Inc., GlaxoSmithKline, Grey Healthcare Group, Ikaria, Janssen Pharmaceuticals, Inc, MedImmune, Merck, Pearl Therapeutics, Projects In Knowledge, Sudler & Hennessey, Takeda/Nycomed, and Vertex. He serves as a speaker for the American Institute for Research, CME Incite, GlaxoSmithKline, Medscape/WebMD, NACE, NCME, Takeda/Nycomed, University of Illinois, UpToDate Inc, UTSW Medicine, and Wayne State University. Dr Martinez receives royalties from Informa. Education Partner Financial Disclosure Statement The content collaborators at CME Incite report the following: Rose O Connor, PhD, has no financial relationships to disclose.
4 SESSION 4 1 2:15pm Tools for Diagnosis, Assessment, and Management of Chronic Obstructive Disease in Clinical Practice SPEAKERS Jill Ohar, MD Fernando J. Martinez, MD, MS Presenter Disclosure Information The following relationships exist related to this presentation: Jill Ohar, MD, has no financial relationships to disclose. Fernando J. Martinez, MD, MS, has served as a consultant for Bayer; Forest Pharmaceuticals, Inc; GlaxoSmithKline; Grey Healthcare; Ikaria; Janssen; MedImmune; Merck; Pearl; Projects in Knowledge; Sudler & Hennessey; Takeda/Nycomed; and Vertex Pharmaceuticals. Dr. Martinez has been a speaker for the American Institute for Research; CME Incite; GlaxoSmithKline; MedScape/WebMD; NACE; NCME; Takeda/Nycomed; University of Illinois; UpToDate; UTSW; Wayne State University; and has received royalties from Informa. Off-Label/Investigational Discussion In accordance with pmicme policy, faculty have been asked to disclose discussion of unlabeled or unapproved use(s) of drugs or devices during the course of their presentations. Drug List Generic Trade Tiotropium Spiriva Formoterol Foradil Theophylline Aquaphyllin Albuterol Various Ipratropium Atrovent Terbutaline Various Ipratropium/albuterol Combivent Roflumilast Daxas, Daliresp Aclidinium bromide Tudorza Indacaterol Onbrez Olodaterol Striverdi Learning Objectives Utilize recommendations, such as those of GOLD and the COPD Foundation, for the diagnosis of COPD, including the use of spirometry and evaluation of symptoms Evaluate and differentiate between standard COPD therapies for decreasing exacerbations and improving symptoms and other outcomes Integrate recently approved agents into the COPD treatment armamentarium through evidence-based decision-making Meet Maggie Assess for COPD: A Common Story Maggie, a 62-year-old woman presents to your office I just have a little cough and cold, but my daughter thinks it has been going on for too long now, so she made this appointment for me. To her surprise, you diagnose Maggie with bronchitis. When you question Maggie in more detail, you find out that she has had impaired ability over the last few years. You know, five years ago I was running around the park with my grandkids, but last summer it was all I could do to sit on the bench and watch them. This year, I really couldn t even go out shopping for Christmas presents for them. Exposure to Risk Factors Tobacco smoke Occupational dusts and chemicals Smoke from home cooking and heating fuels Cough Intermittent or daily Present throughout the day; seldom only nocturnal Dyspnea Progressive and persistent Increased effort to breathe, heaviness, air hunger, or gasping Worse during exercise Worse during respiratory infections Sputum Any pattern of chronic sputum production American Thoracic Society/European Respiratory Society Task Force. Standards for the Diagnosis and Management of Patients With COPD. New York, NY: American Thoracic Society;
5 Early Diagnosis: Who Do You Test and How Do You Test? Physical signs of airflow obstruction Rarely present until significant impairment of lung function Low sensitivity and specificity Spirometry Indicated if symptoms are present (dyspnea, chronic cough/sputum) Should be considered if risk factors are present and if 1 or more comorbidities are present Assess: Spirometry to Diagnose Patient convenience You can connect diagnostic information with rest of clinical encounter Diagnostic accuracy Why do office spirometry? Diagnostic power 30% of the time, the diagnosis changes Easy to use Different Types of Spirometers Flow Measuring Spirometers Small Hand-held Spirometers Measuring Spirometer 1. DEEP inhalation 2. BLAST out 3. Keep blowing for 6 seconds 3 Phases of the Forced Expiration Maneuver Spirometry Results Spirometry: Range of Severity (L) Time Curve FVC=3L (L) Normal Spirogram Mild Obstructive Disease FVC Severe Obstructive Disease 1 FEV 1 =1L FEV 1 /FVC= Time (Seconds) 1 FEV Time (Seconds) 2
6 Spirometry Grades to COPD Diagnosis Characteristics Normal Does not rule out emphysema, chronic bronchitis, asthma, or risk of developing either exacerbations or COPD Grade 1: Mild PB FEV 1 /FVC ratio <0.7; FEV 1 60% predicted Grade 2: Moderate PB FEV 1 /FVC ratio <0.7; 30% FEV 1 <60% predicted Grade 3: Severe PB FEV 1 /FVC ratio <0.7; FEV 1 <30% predicted Undefined FEV 1 /FVC ratio >0.7; FEV 1 <80% predicted; consistent with restriction, muscle weakness, and other pathologies GOLD Guide to COPD Diagnosis In patients with FEV 1 /FVC <0.70 Spirometry Grades GOLD 1: Mild GOLD 2: Moderate GOLD 3: Severe GOLD 4: Very Severe Based on Postbronchodilator FEV 1 FEV 1 80% predicted 50% FEV 1 <80% predicted 30% FEV 1 <50% predicted FEV 1 <30% predicted PB, postbronchodilator. Global Initiative for Chronic Obstructive Disease. Accessed January 6, Maggie s Spirometry Results FEV % of predicted FVC FEV 1 /FVC ratio % of predicted 61% Diagnosis: Mild COPD Diagnostic Suspicion: Key Points A clinical diagnosis of COPD should be considered in any patient who has: Symptoms of dyspnea, chronic cough, or sputum production Risk factors and comorbidities Practice Pearl: An in-depth patient history and spirometry results can confirm a diagnosis of COPD. Maggie s response: I ve never even heard of COPD. How can you be sure that my cough and these breathing numbers mean that I have COPD? Vital Capacity (VC) Residual (RV) Hyperinflation in COPD Obstructive Pattern Functional Residual Capacity (FRC) Total Capacity (TLC) Normal Pattern Dynamic Hyperinflation During Exercise TLC Healthy at Rest IC FRC IRV V T ERV RV ERV, expiratory reserve volume; IC, inspiratory capacity; IRV, inspiratory reserve volume; RV, residual volume; V T, tidal volume. Adapted from Denis O Donnell, MD. Healthy During Exercise COPD During Exercise = Hyperinflation 3
7 to COPD Diagnosis: Disease Domains Symptoms Dyspnea at rest or exertion Cough Sputum Exacerbations 2 or more in the past year FEV 1 <50% predicted suggests risk : resting O2 sat <88% or arterial po2 <55 mm Hg : exercise or nocturnal desaturation to COPD Diagnosis: Disease Domains Reduced density on CT scan Abnormal lung volumes Abnormal low diffusion capacity Chronic bronchitis Cough, sputum for at least 3 months in at least 2 years Cardiovascular O2, oxygen; po2, oxygen partial pressure; sat, saturation. CT, computed tomography. Differential Diagnoses (Aside From Asthma) Diagnosis Signs/Symptoms Tests CHF Fine basilar crackles CXR, PFTs, echo Clinical Course of COPD COPD Bronchiectasis Cystic fibrosis Large volumes purulent sputum, repeated infections Onset at any age CT scan, PFTs CXR, sweat test, genetic testing Exacerbations Expiratory flow limitation Air trapping Hyperinflation Breathlessness Bronchiolitis obliterans Onset earlier age, nonsmokers, history of RA, fume exposure CT scan Deconditioning Quality of life Inactivity Diffuse panbronchiolitis Mostly male and nonsmokers, chronic sinusitis in almost all CXR, HRCT Reduced exercise capacity CHF, chronic heart failure; CXR, chest x-ray; HRCT, -resolution CT; PFT, pulmonary function test; RA, rheumatoid arthritis. American Thoracic Society/European Respiratory Society Task Force. Standards for the Diagnosis and Management of Patients With COPD. New York, NY: American Thoracic Society; Disability Disease Progression Death COPD: Systemic Consequences/* Physical deconditioning Exercise intolerance Skeletal muscle dysfunction Osteoporosis Atherosclerotic cardiovascular disease Metabolic syndrome Anemia Anxiety and depression cancer *Mechanistic factors: systemic inflammation and physical inactivity. Nussbaumer-Oschner Y, et al. Chest. 2011;139(1): Goals for Treatment of Stable COPD Relieve symptoms Improve exercise tolerance Improve health status Prevent disease progression Prevent and treat exacerbations Reduce mortality REDUCE SYMPTOMS REDUCE RISK Maggie s goals: I just want to be able to play with my grandkids again. And it is important to me that I am able to go shopping for their Christmas presents this year! Global Strategies for the Diagnosis, Management and Prevention of Chronic Obstructive Disease. Updated
8 Initial Treatment Recommendations How Do We Approach Maggie s Treatment Plan? Smoking cessation Pharmacologic therapy Vaccine Nicotine replacement (transdermal patch, gum, lozenge) Bupropion Varenicline Based on severity Patient response Guidelines Influenza Pneumococcal Maggie quit smoking 20 years ago. You offer Maggie the influenza and pneumoccal vaccines. I don t want to get the flu shot. Everyone that I know gets sick from the flu shot. Isn t there something else you can give me? After you convince Maggie of the benefits of the flu and pneumococcal vaccines, you offer her a first-line treatment. Therapeutic Options for COPD: Formulations and Duration of Action s Drug Class Inhaled Nebulizer Solution β 2 -agonists Anticholinergics Oral Duration of Action, Hours Short acting X X X 4-8 Long acting X X Short acting X X 6-9 Long acting X β 2 -agonists Short Acting (SABA) Fenoterol* Salbutamol (albuterol) Terbutaline Anticholinergics Short Acting Ipratropium bromide Combinations and Methylxanthines Combination β 2 -agonists Plus Anticholinergic in 1 Inhaler Fenoterol/ipratropium* Salbutamol/ipratropium Combination short-acting β 2 -agonists plus anticholinergic in 1 inhaler X X 6-8 Methylxanthines X Up to 24 Inhaled corticosteroids X X Systemic corticosteroids X PDE-4 inhibitors X 24 Long Acting () Formoterol Salmeterol Indacaterol Olodaterol* Long Acting (LAMA) Tiotropium Aclidinium Methylxanthines Aminophylline (slowrelease preparations) Theophylline (slowrelease preparations) Level 8-12 mcg/ml PDE-4, phosphodiesterase-4. * Not available in the U.S. Global Strategies for the Diagnosis, Management and Prevention of Chronic Obstructive Disease. Updated Chronic bronchitis * Chronic bronchitis * * Indicated if chronic bronchitis, exacerbation risk, and spirometry grades 2/3 present. All potential options depending upon * Indicated if chronic bronchitis, exacerbation risk, and spirometry grades 2/3 present. All potential options depending upon 5
9 Follow-up With Maggie You recommend therapy for Maggie Long-acting anticholinergic β 2 -agonist (PRN) rehabilitation Maggie returns for her first follow-up visit: At first I thought the medications were working, but now I m not sure. I feel as though I have been getting short of breath a lot. And this cough seems to be coming back maybe even worse than before. Chronic bronchitis * PRN, as. * Indicated if chronic bronchitis, exacerbation risk, and spirometry grades 2/3 present. All potential options depending upon Chronic bronchitis * Chronic bronchitis * * Indicated if chronic bronchitis, exacerbation risk, and spirometry grades 2/3 present. All potential options depending upon * Indicated if chronic bronchitis, exacerbation risk, and spirometry grades 2/3 present. All potential options depending upon Chronic bronchitis * Chronic bronchitis * * Indicated if chronic bronchitis, exacerbation risk, and spirometry grades 2/3 present. All potential options depending upon * Indicated if chronic bronchitis, exacerbation risk, and spirometry grades 2/3 present. All potential options depending upon 6
10 Let s Check in With Maggie You prescribe a At her follow-up visit, you repeat spirometry: Sometimes puffing out a big breath of air is hard for me. Do I really need to blow into this thing again? Didn t you get the information that you the first time I did this? Spirometry is an important tool for assessing the efficacy of therapy and establishing a new baseline Clinical Considerations Many therapies available as monotherapy or in combination Long-acting -agonists Long-acting muscarinic antagonists Inhaled corticosteroids What should we consider when selecting a therapy? Safety Efficacy Delivery system Patient preference, reimbursement What if Maggie What if Maggie Had an exacerbation I have been coughing again, and I am really coughing up a lot of phlegm. It sure has me tired too I can t make myself a sandwich without getting tired now. Consider exchanging ICS for after treating exacerbation Still not achieving adequate exacerbation control after several months Doc, are you telling me that I have bronchitis again? What s going on with me? I am sicker now than I have been in years. Consider adding roflumilast for exacerbation control Advances in COPD Treatment and Prevention New Inhaled Therapeutic Options Indacaterol inhalation powder Ipratropium bromide and albuterol inhalation spray Aclidinium bromide inhalation powder Fluticasone furoate and vilanterol inhalation powder Novel Agents as Preventive Therapy for COPD Exacerbations Antibiotics PDE-4 inhibitors How can these new agents benefit our patients with COPD? Summary Spirometry is a useful tool in suspected of COPD FEV 1 /FVC <70%, 80% FEV 1 predicted is considered mild COPD Offer influenza and pneumococcal vaccines Benefits/goals of pharmacotherapy Improve exercise tolerance Reduce exacerbations Adjust treatment strategies to disease stage Mild disease: avoid risk factors and add a short-acting bronchodilator when Moderate disease: add a long-acting bronchodilator when Severe disease: add an inhaled glucocorticoid, and with frequent exacerbations, add a PDE-4 inhibitor or azithromycin 7
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