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State-of-the-Art Overview of COPD and its Management State-of-the-Art Overview of COPD and its Management Presentation Transcript

  • State-of-the-Art Overview of COPD and its Management David J Pierson MD Professor of Medicine University of Washington Seattle, WA, USA December, 2008
  • What’s New in COPD in 2008?
    • The science:
      • COPD as a systemic disease
      • Importance of exacerbations
      • Lung remodeling
      • Exhaled biomarkers
    • New studies:
      • TORCH, INSPIRE, UPLIFT, PULSE, COPD Network
  • What’s New in COPD in 2008?
    • Outcome measures
      • FEV 1  hyperinflation  6-min walk  exacerbations  quality of life
    • Lung-volume-reduction surgery
    • Screening versus case finding
    • Disease management in COPD
    View slide
  • Current Guidelines: www.goldcopd.org
    • Full workshop report
    • Executive summary
    • Pocket guide for clinicians
    • Slide set
    • Patient teaching materials
    View slide
  • Consensus Standards and Practice Guidelines for COPD Management GOLD : Respir Care . 2001 Aug;46(8):798-825; Updated Eur Respir J . 2003 Jul;22(1):1-2. www.goldcopd.com American Thoracic Society - European Thoracic Society : Eur Respir J . 2004 Jun;23(6):932-46. www.thoracic.org (Other national guidelines from Australia–New Zealand, Canada, Finland, France, Germany, India, Malaysia, South Africa, Switzerland, the UK, and others) Review and comparison of current guidelines: Pierson DJ, Respir Care 2006 (Mar);51(3):277-288.
  • State-of-the-Art Overview of COPD in 2008
    • Making the diagnosis
    • Determining severity and prognosis
    • Available therapies and what we know about their efficacy
    • Matching the therapy to the patient
    • Barriers to effectiveness
  • Epidemiology of COPD*
    • 10.1 million people in US
    • 120,000 deaths in 2000
    • 750,000 hospitalizations
    • 1.5 million ER visits
    • 8 million office/clinic visits
    *Mannino DM, Respir Care 2003;48(12):1185-91
  • Change in Age-Adjusted US Death Rates, 1965-1998* *www.goldcopd.com Percentage of 1965 Rate 50 100 150 200 250 Coronary Heart Disease Stroke Other CVD All Other Causes COPD -59% -64% -35% +163% -7%
  • Deaths from COPD in the US *Mannino DM, Respir Care 2003;48(12):1185-91
  • A 72 year old man has smoked 2 PPD for 40 years. He has a daily productive cough and dyspnea on walking 2 blocks. What is his diagnosis?
    • (A) Chronic bronchitis
    • (B) Moderate COPD
    • (C) Severe COPD
    • (D) Insufficient information to make any diagnosis
  • A 72 year old man has smoked 2 PPD for 40 years. He has a daily productive cough and dyspnea on walking 2 blocks. What is his diagnosis?
    • (A) Chronic bronchitis
    • (B) Moderate COPD
    • (C) Severe COPD
    • (D) Insufficient information to make any diagnosis
  • Definition of COPD*
    • A disease state characterized by airflow limitation (obstruction) that is not fully reversible
    • FEV 1 /FVC 70% or less
    *Global Initiative on Obstructive Lung Disease (GOLD)
  • Diagnosing COPD with Spirometry* *www.goldcopd.com
  • Use of Spirometry to Diagnose COPD* *Global Initiative for Obstructive Lung Disease Guideline (2007 Revision); www.goldcopd.org
  • Should the General Public Be Screened for COPD with Spirometry?
  •  
  •  
  • GOLD Staging System for COPD* *www.goldcopd.com
  • Which of the following tests is the best predictor of overall prognosis in patients with COPD?
    • (A) History and physical exam
    • (B) Chest X-ray
    • (C) Spirometry
    • (D) Diffusing capacity
    • (E) 6-minute walk test
  • Which of the following tests is the best predictor of overall prognosis in patients with COPD?
    • (A) History and physical exam
    • (B) Chest X-ray
    • (C) Spirometry
    • (D) Diffusing capacity
    • (E) 6-minute walk test
  • Prognostic Value of Spirometry in COPD Survival among patients with COPD as a function of FEV 1 when first enrolled in cohort *  = FEV 1 > 1.25 L  = FEV 1 1.25-0.75 L  = FEV 1 < 0.75 L (Correspond approximately to 2003 GOLD Stages II/III/IV) *Diener CF, Burrows B. Am Rev Respir Dis 1975;111:719-24
  • Natural History of COPD
    • Making the diagnosis
    • Determining severity and prognosis
    • Available therapies and what we know about their efficacy
    • Matching the therapy to the patient
    • Barriers to effectiveness
    State-of-the-Art Overview of COPD in 2008
  • Components of Effective COPD Management
    • Assess and monitor disease
    • Reduce risk factors
    • Manage stable COPD
    • Manage exacerbations
    *www.goldcopd.com
  • Available Therapies for Managing Stable COPD
    • Smoking cessation
    • Bronchodilators
      • (  -agonists; anticholinergics)
    • Inhaled corticosteroids
    • Vaccines and other medications
    • Pulmonary rehabilitation
    • Long-term oxygen therapy
    • LVRS and other surgical therapies
  • Smoking Cessation in COPD*
    • Increases survival
    • Slows rate of functional loss
    • Improves quality of life
    • Most important of all treatment interventions
    *Marlow SP,Stoller JK, Respir Care 2003;48(12):1238-54
  • Using More Different Smoking Cessation Formats Increases the Success Rate *Marlow SP,Stoller JK, Respir Care 2003;48(12):1238-54
  • More Individual Smoking Cessation Sessions Increase the Success Rate *Marlow SP,Stoller JK, Respir Care 2003;48(12):1238-54
  • More Contact Time Increases the Likelihood of Success *Marlow SP,Stoller JK, Respir Care 2003;48(12):1238-54
  • Management of Stable COPD*
    • No medication has been shown to affect the rate of lung function decline [Evidence level A]
    • Pharmacotherapy is used to improve symptoms and/or decrease complications
      • Bronchodilators [Evidence level A]
      • Inhaled corticosteroids (selected patients) [Evidence level A]
    *www.goldcopd.com
  • Inhaled Bronchodilators in COPD
    • Beta-agonist sympathomimetics
      • Short-acting (albuterol, et al)
      • Long-acting (salmeterol, formoterol)
    • Anticholinergics
      • Short-acting (ipratropium)
      • Long-acting (tiotropium)
    • Combinations
  • Sutherland & Cherniack, NEJM 2004;350:2689-97
  • *Sutherland & Cherniack, NEJM 2004;350:2689-97 Lung Hyperinflation in COPD*
  • Effect of Long-Acting Beta 2 -Agonists on COPD Exacerbations* *Sin DD et al, JAMA 2003;290:2301-12 Meta-analysis of 9 clinical trials (4198 patients)
  • Effect of Tiotropium on COPD Exacerbations* *Sin DD et al, JAMA 2003;290:2301-12 Meta-analysis of 5 clinical trials (3574 patients)
  • Relationship Between FEV 1 and Effect of Inhaled Corticosteroids in Preventing COPD Exacerbations* Greater Effect in More Severely Obstructed Patients *Sin DD et al, JAMA 2003;290:2301-12
  • Salmeterol, Fluticasone, and Their Combination in COPD: The TORCH Study* *Calverley PMA et al, NEJM 2007;356:775-789
    • 3-yr double-blind RCT of Advair (50 μ g salmeterol/500 μ g fluticasone) vs each component separately vs placebo
    • COPD patients with FEV 1 < 60 % predicted and < 10 % reversibility
    • 444 centers in 42 countries; 6112 pts
    • Sponsored by GSK
  • Salmeterol, Fluticasone, and Their Combination in COPD: The TORCH Study* *Calverley PMA et al, NEJM 2007;356:775-789
    • All-cause mortality rates:
      • Placebo 15.2%
      • Salmeterol only 13.5%
      • Fluticasone only 16.0%
      • Combination 12.6%
    P = 0.052
  • Salmeterol, Fluticasone, and Their Combination in COPD: The TORCH Study* *Calverley PMA et al, NEJM 2007;356:775-789
    • Other outcomes, placebo vs combination:
    • (all, statistically significant at P < 0.01)
      • Exacerbations/year: 1.13 vs 0.85
      • (Requiring prednisone: 0.80 vs 0.64)
      • FEV 1 change/year: -62 mL vs -21 mL
      • Change in SGRQ score over 3 years:
      • +0.2 vs -3.0
    (Clinically relevant: > 4 points)
  • Salmeterol, Fluticasone, and Their Combination in COPD: The TORCH Study* *Calverley PMA et al, NEJM 2007;356:775-789
    • Other outcomes, placebo vs combination:
    • (all, statistically significant at P < 0.01)
      • Exacerbations/year: 1.13 vs 0.85
      • (Requiring prednisone: 0.80 vs 0.64)
      • FEV 1 change/year: -62 mL vs -21 mL
      • Change in SGRQ score over 3 years:
      • +0.2 vs -3.0 (Clinically relevant: >4 points)
      • Percentage of patients having pneumonia during study: 12.3 vs 19.6
  • Salmeterol, Fluticasone, and Their Combination in COPD: The TORCH Study 1 1 Calverley PMA et al, NEJM 2007;356:775-89 2 Rabe KF (Editorial), NEJM 2007;356:851-4
    • Mortality was not significantly different.
    • Differences in outcomes that were statistically significant were small and of uncertain clinical significance.
    • Many enrolled patients dropped out of the study.
    • Numerous unanswered questions remain. 2
  • Additional Therapies in COPD: Recommended*
    • Influenza vaccine (Evidence level A)
    • Pneumococcal vaccine (Evidence level B)
    *www.goldcopd.com
  • Additional Therapies in Stable COPD: Not Recommended*
    • Antibiotics Antitussives
    • Mucolytics Respiratory stimulants
    • Antioxidants Immunomodulators
    • Narcotics Leukotriene modifiers
    *www.goldcopd.com
  • Effect of Pulmonary Rehabilitation on Health-Related Quality of Life in COPD* *Sin DD et al, JAMA 2003;290:2301-12 Meta-analysis of 6 clinical trials (491 patients) SGRQ, St George’s Respiratory Questionnaire
  • Effects of Pulmonary Rehabilitation on Functional Exercise Capacity* *Lacasse Y et al, Cochrane Database Syst Rev 2006;Oct 18(4):CD007793
  • Effects of Pulmonary Rehabilitation on Dyspnea* *Lacasse Y et al, Cochrane Database Syst Rev 2006;Oct 18(4):CD007793
  • Effects of Pulmonary Rehabilitation on St Georges Respiratory Questionnaire (Total)* *Lacasse Y et al, Cochrane Database Syst Rev 2006;Oct 18(4):CD007793
  • Available Therapies for Managing Stable COPD
    • Smoking cessation
    • Bronchodilators
      • (  -agonists; anticholinergics)
    • Inhaled corticostaroids
    • Vaccines and other medications
    • Pulmonary rehabilitation
    • Long-term oxygen therapy
    • LVRS and other surgical therapies
  • Long-Term Oxygen Therapy in COPD
    • Increases survival in appropriate patients [Evidence level A]
    • May also improve:
      • Hemodynamics
      • Hematologic characteristics
      • Exercise capacity
    • Lung mechanics
      • Mental state
    *www.goldcopd.com
  • LTOT: Selection of Patients*
    • Stage III or IV COPD
      • FEV 1 /FVC < 70%
      • FEV 1 < 50% of predicted value
    • Hypoxemia while awake, at rest:
      • PaO 2 55 mm Hg or less, or SpO 2 88% or less
      • Less severe hypoxemia if signs of end-organ effects are present
    *www.goldcopd.com
  • LTOT: Selection of Patients
    • Hypoxemia only during exercise:
      • Qualifies for reimbursement
      • May improve exercise capacity
      • Evidence for other benefits weak/absent
    • Hypoxemia only during sleep*:
      • Qualifies for reimbursement
      • Identifies poor prognostic group
      • No evidence for beneficial effect on long-term outcomes
    *Not due to sleep apnea or other sleep disorder
  • Goals for Oxygen Therapy in COPD
    • As close to 24-hr usage as possible
    • PaO 2 > 60 mm Hg (SpO 2 > 90%)
      • May need to increase flow:
        • during exercise
        • during sleep
  • Surgical Treatments for COPD*
    • Lung volume reduction surgery
    • Bullectomy
    • Lung transplantation
    *Benditt JO, Respir Care 2004;49(1):53-61
  • Apical Bullae in COPD* *Dunnill MS. Pulmonary Pathology. Edinburgh, Churchill Livingstone, 1987:115
    • Making the diagnosis
    • Determining severity and prognosis
    • Available therapies and what we know about their efficacy
    • Matching the therapy to the patient
    • Barriers to effectiveness
    State-of-the-Art Overview of COPD in 2008
  • GOLD Guidelines for Stepwise COPD Management
    • Making the diagnosis
    • Determining severity and prognosis
    • Available therapies and what we know about their efficacy
    • Matching the therapy to the patient
    • Barriers to effectiveness
    State-of-the-Art Overview of COPD in 2008
  • Barriers to Adherence with Prescribed Therapy in COPD*
    • Related to the therapy itself
    • Related to the patient
    • Related to us—the providers
    *Make BJ, Respir Care 2003;48(12):1225-34
  • Barriers to Adherence with Prescribed Therapy in COPD*
    • Related to the treatment itself
      • Purpose
      • Duration
      • Onset
      • Expense
      • Complexity
    *Make BJ, Respir Care 2003;48(12):1225-34
  • Cost of Managing COPD According to Current Guidelines (Pierson DJ, Respir Care 2006;51(3):277-288) Monthly Cost ($) add LTOT add ICS add LABD SABD as needed 0 100 200 300 400 500 600 700 800 Mild (GOLD I) Moderate (GOLD II) Severe (GOLD III) Very Severe (GOLD IV)
  •  
  •  
  •  
  • Barriers to Adherence with Prescribed Therapy in COPD*
    • Related to the patient
      • Motivation
      • Acceptance of disease, goals, therapies
      • Cultural and family factors
      • Economic factors
      • Access to health care, Rx, etc
    *Make BJ, Respir Care 2003;48(12):1225-34
  • Language Barriers to Health Care in the US* *Data from US Census Bureau; Flores G, NEJM 2006;355(3):229-31 *
  • * Prose Literacy Levels Among US Adults in 2003. Marcus EN, NEJM 2006;355(4):339-41 Barriers to Effective Health Care: Literacy in the US*
  • Barriers to Adherence with Prescribed Therapy in COPD*
    • Related to healthcare providers
      • Practitioner-patient relationship
      • Accessability to patients
      • Lack of patient-centered goals
      • Inadequate patient education
    *Make BJ, Respir Care 2003;48(12):1225-34
  • Improving COPD Management: The Easy Stuff & The Hard Stuff*
    • The Easy Stuff
      • Prescribing drugs, O 2 , etc
    *Pierson DJ, Respir Care 2004;49:99-109
    • The Hard Stuff (for both clinician & pt)
      • Smoking cessation
      • Using inhaled medications & O 2 optimally
      • Pulmonary rehab
      • Navigating the system