G O L D. lobal Initiative for Chronic bstructive ung isease

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1 G O L D lobal Initiative for Chronic bstructive ung isease

2 Global Initiative for Chronic Obstructive Lung Disease In collaboration with: National Heart, Lung, and Blood Institute, NIH and World Health Organization

3 GOLD Executive Committee R. Pauwels, Belgium Chair S. Buist, US C. Jenkins, Australia P. Calverley, UK N. Khaltaev, Switzerland B. Celli, US C. Lenfant, US Y. Fukuchi, Japan J. Luna, Guatemala S. Hurd, US W. MacNee, UK L. Grouse, US N. Zhong, China

4 GOLD Expert Panel R. Pauwels, Belgium Chair N. Anthonisen, Canada C. Jenkins, Australia W. Bailey, US D. Postma, Netherlands P. Barnes, UK K. Rabe, Netherlands S. Buist, US S. Ramsey, US P. Calverley, UK S. Rennard, US T. Clark, UK R. Rodriguez-Roisin, Spain L. Fabbri, Italy N. Siafakas, Greece Y. Fukuchi, Japan S. Sullivan, US J. Hogg, Canada W. Tan, Singapore

5 GOLD Sponsors ASTA Medica AstraZeneca Aventis Bayer Boehringer-Ingelheim Byk Gulden Chiesi GlaxoSmithKline Merck Sharp & Dohme Mitsubishi-Tokyo Nikken Chemicals Novartis Schering-Plough Yamanouchi Zambon

6 Facts About COPD COPD is the 4 th leading cause of death in the United States (behind heart disease, cancer, and cerebrovascular disease). In 2000, the WHO estimated 2.74 million deaths worldwide from COPD. In 1990, COPD was ranked 12 th as a burden of disease; by 2020 it is projected to rank 5 th.

7 Leading Causes of Deaths U.S Cause of Death Number 1. Heart Disease 724, Cancer 538, Cerebrovascular disease (stroke) 158, Respiratory Diseases (COPD) 114, Accidents 94, Pneumonia and influenza 93, Diabetes 64, Suicide 29, Nephritis 26, Chronic liver disease 24,936 All other causes of death 469,314

8 Percent Change in Age-Adjusted Death Rates, U.S., Proportion of 1965 Rate Coronary Heart Disease Stroke Other CVD COPD All Other Causes % 64% 35% +163% 7%

9 Age-Adjusted Death Rates for COPD, U.S., Deaths per 100, White Male Black Male White Female Black Female

10 Facts About COPD Between 1985 and 1995, the number of physician visits for COPD in the United States increased from 9.3 million to 16 million. The number of hospitalizations for COPD in 1995 was estimated to be 500,000. Medical expenditures amounted to an estimated $14.7 billion.

11 COPD 1990 Prevalence Established Market Economies Formerly Socialist Economies India China Other Asia and Islands Sub-Saharan Africa Latin America and Caribbean Middle Eastern Crescent World *From Murray & Lopez, 1996 Male/1000 Female/1000

12 Facts About COPD Between 1985 and 1995, the number of physician visits for COPD in the United States increased from 9.3 million to 16 million. The number of hospitalizations for COPD in 1995 was estimated to be 500,000. Medical expenditures amounted to an estimated $14.7 billion.

13 Number (Millions) 15 Physician Office Visits for Chronic and Unspecified Bronchitis, U.S Source: National Ambulatory Medical Care Survey, NCHS Year

14 Facts About COPD Cigarette smoking is the primary cause of COPD. In the US 47.2 million people (28% of men and 23% of women) smoke. The WHO estimates 1.1 billion smokers worldwide, increasing to 1.6 billion by In low- and middle-income countries, rates are increasing at an alarming rate.

15 Facts About COPD In India, it is estimated that thousand premature deaths can be attributed annually to use of biomass fuels, placing indoor air pollution as a major risk factor in the country. In Algeria, the prevalence of tuberculosis and acute respiratory infections has decreased since 1965; an increase in COPD and asthma has been observed in the last decade.

16 G O L D lobal Initiative for Chronic bstructive ung isease

17 GOLD Objectives Increase awareness of COPD among health professionals, health authorities, and the general public Improve diagnosis, management, and prevention Stimulate research

18 GOLD Documents Workshop Report: Global Strategy for the Diagnosis, Management, and Prevention of COPD Executive Summary Pocket Guide for health care providers Guide for patients and their families (available late 2001)

19 GOLD Workshop Report Evidence-based Implementation oriented Diagnosis Management Prevention Outcomes can be evaluated

20 GOLD Workshop Report Evidence category Sources of evidence A Randomized clinical trials Rich body of data B Randomized clinical trials Limited body of data C Non randomized trials Observational studies D Panel judgment consensus

21 GOLD Workshop Report: Contents Introduction Definition and classification Burden of COPD Risk factors Pathogenesis, pathology, and pathophysiology Management Future research

22 Definition of COPD Chronic obstructive pulmonary disease (COPD) is a disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually both progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases.

23 Burden of COPD Key Points The burden of COPD is underestimated because it is not usually recognized and diagnosed until it is clinically apparent and moderately advanced. Prevalence, morbidity, and mortality vary appreciably across countries but in all countries where data are available, COPD is a significant health problem in both men and women.

24 Burden of COPD Key Points The global burden of COPD will increase enormously over the foreseeable future as the toll from tobacco use in developing countries becomes apparent.

25 Burden of COPD Key Points The economic costs of COPD are high and will continue to rise in direct relation to the ever-aging population, the increasing prevalence of the disease, and the cost of new and existing medical and public health interventions.

26 Direct and Indirect Costs of COPD, 1993 (US $ Billions) Direct Medical Cost: $14.7 Total Indirect Cost: $ 9.2 Mortality related IDC 4.5 Morbidity related IDC 4.7 Total Cost $23.9

27 Risk Factors for COPD Host Factors Exposure Genes (e.g. alpha1-antitrypsin deficiency) Hyperresponsiveness Lung growth Tobacco smoke Occupational dusts and chemicals Infections Socioeconomic status

28 Pathogenesis of COPD NOXIOUS AGENT (tobacco smoke, pollutants, occupational agent) Genetic factors Respiratory infection Other COPD

29 Noxious particles and gases Anti-oxidants Lung inflammation Host factors Anti-proteinases Oxidative stress Proteinases Repair mechanisms COPD pathology

30 INFLAMMATION Small airway disease Airway inflammation Airway remodeling Parenchymal destruction Loss of alveolar attachments Decrease of elastic recoil AIRFLOW LIMITATION

31 ASTHMA Sensitizing agent COPD Noxious agent Asthmatic airway inflammation CD4+ T-lymphocytes Eosinophils COPD airway inflammation CD8+ T-lymphocytes Macrophages Neutrophils Completely reversible Airflow limitation Completely irreversible

32 Causes of Airflow Limitation Irreversible Fibrosis and narrowing of the airways Loss of elastic recoil due to alveolar destruction Destruction of alveolar support that maintains patency of small airways

33 Causes of Airflow Limitation Reversible Accumulation of inflammatory cells, mucus, and plasma exudate in bronchi Smooth muscle contraction in peripheral and central airways Dynamic hyperinflation during exercise

34 GOLD Workshop Report Four Components of COPD Management Assess and monitor disease Reduce risk factors Manage stable COPD Education Pharmacologic Non-pharmacologic Manage exacerbations

35 Objectives of COPD Management Prevent disease progression Relieve symptoms Improve exercise tolerance Improve health status Prevent and treat exacerbations Prevent and treat complications Reduce mortality Minimize side effects from treatment

36 GOLD Workshop Report Four Components of COPD Management Assess and monitor disease Reduce risk factors Manage stable COPD Education Pharmacologic Non-pharmacologic Manage exacerbations

37 Assess and Monitor Disease: Key Points Diagnosis of COPD is based on a history of exposure to risk factors and the presence of airflow limitation that is not fully reversible, with or without the presence of symptoms.

38 Assess and Monitor Disease: Key Points Patients who have chronic cough and sputum production with a history of exposure to risk factors should be tested for airflow limitation, even if they do not have dyspnea.

39 Assess and Monitor Disease: Key Points For the diagnosis and assessment of COPD, spirometry is the gold standard. Health care workers involved in the diagnosis and management of COPD patients should have access to spirometry.

40 Assess and Monitor Disease: Key Points Measurement of arterial blood gas tension should be considered in all patients with FEV 1 < 40% predicted or clinical signs suggestive of respiratory failure or right heart failure.

41 Diagnosis of COPD SYMPTOMS cough sputum dyspnea EXPOSURE TO RISK FACTORS tobacco occupation indoor/outdoor pollution SPIROMETRY

42 Spirometry: Normal and COPD 0 1 N o rm a l C O P D F E V 1 F V C F E V 1 / F V C % % 2 F E V 1 Liter 3 4 F E V 1 C O P D F V C 5 N o rm a l F V C S e c o n d s

43 Factors Determining Severity Of Chronic COPD Severity of symptoms Severity of airflow limitation Frequency and severity of exacerbations Presence of complications of COPD Presence of respiratory insufficiency Comorbidity General health status Number of medications needed to manage the disease

44 Classification by Severity Stage Characteristics 0: At risk Normal spirometry Chronic symptoms (cough, sputum) I: Mild FEV 1 /FVC < 70%; FEV 1 80% predicted With or without symptoms (cough, sputum) II: Moderate FEV 1 /FVC < 70%; 30% FEV 1 < 80% predicted (IIA: 50% FEV 1 < 80% predicted; IIB: 30% FEV 1 < 50% predicted) With or without chronic symptoms (cough, sputum, dyspnea) III: Severe FEV 1 /FVC < 70%; FEV 1 < 30% predicted or FEV 1 < 50%predicted plus respiratory failure or clinical signs of right heart failure

45 Stage At risk Mild Moderate Severe Examples of individual patient histories age A Stage III II I 0 age B Stage At risk age C Stage 0 age D Mild I Moderate II Severe III

46 GOLD Workshop Report Four Components of COPD Management Assess and monitor disease Reduce risk factors Manage stable COPD Education Pharmacologic Non-pharmacologic Manage exacerbations

47 Reduce Risk Factors Key Points Reduction of total personal exposure to tobacco smoke, occupational dusts and chemicals, and indoor and outdoor air pollutants are important goals to prevent the onset and progression of COPD. Smoking cessation is the single most effective-and cost-effective- intervention to reduce the risk of developing COPD and stop its progression (Evidence A).

48 Reduce Risk Factors Key Points Brief tobacco dependence treatment is effective (Evidence A), and every tobacco user should be offered at least this treatment at every visit to a health care provider. Three types of counseling are especially effective: practical counseling, social support as part of treatment, and social support arranged outside of treatment (Evidence A).

49 Reduce Risk Factors Key Points Several effective pharmacotherapies for tobacco dependence are available (Evidence A), and at least one of these medications should be added to counseling if necessary, and in the absence of contraindications.

50 Reduce Risk Factors Key Points Progression of many occupationallyinduced respiratory disorders can be reduced or controlled through a variety of strategies aimed at reducing the burden of inhaled particles and gases (Evidence B).

51 Brief Strategies To Help The Patient Willing To Quit Smoking ASK ADVISE ASSESS ASSIST ARRANGE Systematically identify all tobacco users at every visit. Strongly urge all tobacco users to quit. Determine willingness to make a quit attempt. Aid the patient in quitting. Schedule follow-up contact.

52 GOLD Workshop Report Four Components of COPD Management Assess and monitor disease Reduce risk factors Manage stable COPD Education Pharmacologic Non-pharmacologic Manage exacerbations

53 Manage Stable COPD Key Points The overall approach to managing stable COPD should be characterized by a stepwise increase in the treatment, depending on the severity of the disease. For patients with COPD, health education can play a role in improving skills, ability to cope with illness, and health status. It is effective in accomplishing certain goals, including smoking cessation (Evidence A).

54 Manage Stable COPD Key Points None of the existing medications for COPD has been shown to modify the long-term decline in lung function that is the hallmark of this disease (Evidence A). Therefore, pharmacotherapy for COPD is used to decrease symptoms and/or complications.

55 Manage Stable COPD Key Points Bronchodilator medications are central to the symptomatic management of COPD (Evidence A). They are given on an as-needed basis or on a regular basis to prevent or reduce symptoms. The principal bronchodilator treatments are Beta 2 - agonists, anticholinergics, theophylline, and a combination of these drugs (Evidence A).

56 Bronchodilators in Stable COPD Bronchodilator medications are central to symptom management in COPD. Inhaled therapy is preferred. The choice between Beta 2 -agonist, anticholinergic, theophylline or combination therapy depends on availability and individual response in terms of symptoms relief and side effects.

57 Bronchodilators in Stable COPD Bronchodilators are prescribed on an as-needed or on a regular basis to prevent or reduce symptoms. Long-acting inhaled bronchodilators are more convenient. Combining bronchodilators may improve efficacy and decrease the risk of side effects compared to increasing the dose of a single bronchodilator.

58 Manage Stable COPD Key Points Regular treatment with inhaled glucocorticosteroids should only be prescribed for symptomatic COPD patients with a documented spirometric response to glucocorticosteroids or in those with an FEV 1 < 50% predicted and repeated exacerbations requiring treatment with antibiotics and/or oral glucocorticosteroids (Evidence B).

59 Manage Stable COPD Key Points Chronic treatment with systemic glucocorticosteroids should be avoided because of an unfavorable benefit-to-risk ratio (Evidence A). All COPD-patients benefit from exercise training programs, improving with respect to both exercise tolerance and symptoms of dyspnea and fatigue (Evidence A).

60 Manage Stable COPD Key Points The long-term administration of oxygen (> 15 hours per day) to patients with chronic respiratory failure has been shown to increase survival (Evidence A).

61 Management of COPD by Severity of Disease Stage 0: At risk Stage 1: Mild COPD Stage 2: Moderate COPD Stage 3: Severe COPD

62 Management of COPD: All stages Avoidance of noxious agents - smoking cessation - reduction of indoor pollution - reduction of occupational exposure Influenza vaccination

63 Management of COPD Stage 0: At Risk Characteristics Recommended Treatment Chronic symptoms - cough - sputum No spirometric abnormalities

64 Management of COPD Stage I: Mild COPD Characteristics Recommended Treatment FEV 1 /FVC < 70 % FEV 1 > 80 % predicted With or without symptoms Short-acting bronchodilator as needed

65 Management of COPD Stage IIA: Moderate COPD Characteristics Recommended Treatment FEV 1 /FVC < 70% 50% < FEV 1 < 80% predicted With or without symptoms Regular treatment with one or more bronchodilators Rehabilitation Inhaled glucocorticosteroids if significant symptoms and lung function response

66 Management of COPD Stage IIB: Moderate COPD Characteristics Recommended Treatment FEV 1 /FVC < 70% 30% < FEV 1 < 50% predicted With or without symptoms Regular treatment with one or more bronchodilators Rehabilitation Inhaled glucocorticosteroids if significant symptoms and lung function response or if repeated exacerbations

67 Management of COPD Stage III: Severe COPD Characteristics Recommended Treatment FEV 1 /FVC < 70% FEV 1 < 30% predicted or presence of respiratory failure or right heart failure Regular treatment with one or more bronchodilators Inhaled glucocorticosteroids if significant symptoms and lung function response or if repeated exacerbations Treatment of complications Rehabilitation Long-term oxygen therapy if respiratory failure Consider surgical options

68 GOLD Workshop Report Four Components of COPD Management Assess and monitor disease Reduce risk factors Manage stable COPD Education Pharmacologic Non-pharmacologic Manage exacerbations

69 Manage Exacerbations Key Points Exacerbations of respiratory symptoms requiring medical intervention are important clinical events in COPD. The most common causes of an exacerbation are infection of the tracheobronchial tree and air pollution, but the cause of about one-third of severe exacerbations cannot be identified (Evidence B).

70 Manage Exacerbations Key Points Inhaled bronchodilators (Beta 2 -agonists and/or anticholinergics), theophylline, and systemic, preferably oral, glucocorticosteroids are effective for the treatment of COPD exacerbations (Evidence A).

71 Manage Exacerbations Key Points Patients experiencing COPD exacerbations with clinical signs of airway infection (e.g., increased volume and change of color of sputum, and/or fever) may benefit from antibiotic treatment (Evidence B)

72 Manage Exacerbations Key Points Noninvasive intermittent positive pressure ventilation (NIIPPV) in acute exacerbations improves blood gases and ph, reduces inhospital mortality, decreases the need for invasive mechanical ventilation and intubation, and decreases the length of hospital stay (Evidence A).

73 Management of COPD In selecting a treatment plan, the benefits and risks to the individual, and the direct and indirect costs to the individual, his or her family and the community must be considered.

74 GOLD Website Address

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