COPD

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Publication Date: 2005-12-21

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COPD is a deadly disease of the elderly, with patients suffering years of progressive discomfort and disability with no pharmacological interventions able to slow the progressive decline in lung function. A large, increasing patient population demands the development of truly novel COPD-focused therapies which must be coupled with improved disease awareness and diagnosis.

Scope

Analysis of diagnosis, epidemiology, and treatment of COPD

Assessment of the extent to which physicians treat COPD severities differently

Examination of the use of drug classes and brands across the COPD sub-populations

Evaluation of future prescribing trends and the potential of novel COPD therapies

Report Highlights
Current treatment practice will continue to diverge from international guidelines, with the most important change being the increased use of long-acting bronchodilators in mild COPD.

The use of inhaled corticosteroids will continue to be reserved primarily for late stage disease, until alternative anti-inflammatory agents are available from 2010 onwards.

With no revolutionary new drugs in the pipeline, and novel combinations of existing classes of drugs only offering gains patient compliance, improvements in smoking cessation and pulmonary rehabilitation offer the greatest hope to COPD patients.

Reasons to Purchase

Identify the most lucrative target niche populations for developmental products

Understand how to position new COPD therapies

Gain insight into prescribing patterns and physician opinion on current treatment paradigms

About Datamonitor healthcare - page 2
About the Respiratory & Infectious Disease team - page 2

CHAPTER 1 EXECUTIVE SUMMARY - page 4
- Scope - page 4
- Datamonitor insight into the disease market - page 5
CHAPTER 2 DISEASE BACKGROUND - page 10
- COPD is characterized by airflow limitation that is not fully reversible - page 10
- Enigma of COPD pathogenesis - page 11
- Smoking is the primary risk factor - page 14
  - Other risk factors - page 18
- Disease severity is based on lung function and symptoms - page 19
- COPD is a disease of the elderly - page 20
- Prognosis is highly variable - page 22
- Acute exacerbations are the most important complication - page 23
- COPD patients have signifiant comorbidities - page 25
CHAPTER 3 EPIDEMIOLOGY - page 27
- The difficulties in estimating COPD prevalence - page 27
- 28 million patients suffer from COPD - page 28
- COPD population will grow by 14% by 2015 - page 34
CHAPTER 4 DIAGNOSIS - page 38
- Common symptoms may be dismissed as 'just getting older' - page 38
- Gold-standard diagnostic tests are spirometry and reversibility test - page 40
- Smokers do not recognize symptoms - page 44
  - Slow onset of COPD delays diagnosis - page 44
  - Lack of awareness among the general public - page 45
  - Lack of awareness among physicians - page 46
  - Patients may be initially diagnosed as asthmatics - page 46
  - Under-use of spirometry - page 47
- Half of COPD patients may be undiagnosed - page 48
CHAPTER 5 TREATMENT OPTIONS - page 50
- COPD market is valued at nearly $5 billion - page 50
- Bronchodilators are mainstay symptomatic treatment - page 52
  - Beta2-agonists - page 53
  - Anticholinergics - page 55
  - Methyl xanthines - page 56
  - Combination short-acting anticholinergic/short-acting beta2-agonist products - page 57
- Corticosteroids are the only effective anti-inflammatory - page 58
  - Fixed-dose combination inhaled corticosteroid/long-acting beta2-agonist products - page 61
  - Leukotriene antagonists - page 62
- Exacerbations are still not preventable - page 62
- Smoking cessation is key to decreasing decline in FEV1 - page 65
- Other pharmacological treatments combat infection - page 68
- Non-pharmacological treatments - page 68
  - Pulmonary rehabilitation - page 68
    - Exercise training - page 69
    - Education - page 69
    - Emotional support - page 69
    - Breathing training - page 70
    - NUTRITIONAL COUNSELING - page 70
  - Long-term oxygen therapy - page 70
  - Surgery - page 71
    - Lung volume reduction surgery - page 71
    - Lung transplantation - page 71
- Treatment guidelines are comparable - page 72
  - Adherence to guidelines - page 75
CHAPTER 6 PRESCRIBING TRENDS - page 77
- Current prescribing trends do not reflect best practice - page 77
- Many patients with mild COPD prescribed long-acting bronchodilators - page 79
- Inhaled corticosteroids are widely prescribed - page 82
- Country prescribing trends are similar - page 85
- Efficacy drives prescribing behaviour - page 87
  - Fixed-dose ICS/LABA combinations have the highest efficacy - page 87
  - Fixed-dose ICS/LABA combinations are most cost-effective to the payer - page 88
  - Patients are most compliant with fixed-dose ICS/LABA combination - page 90
CHAPTER 7 FUTURE TRENDS - page 92
- Shortfalls with COPD therapies warrant new approaches - page 92
- Alternatives to inhaled corticosteroids remain elusive - page 94
- Novel combinations: same room, different color - page 97
- Improved smoking cessation thearpies are critical - page 101
  - Improving nicotine replacement therapy - page 101
    - Rimonabant - page 102
    - Varenicline - page 103
    - Nicotine vaccines - page 103
- The high prevalence of COPD demands improved awareness and diagnosis - page 104
CHAPTER 8 OPINION LEADER TRANSCRIPTS - page 106
- UK opinion leader - page 106
- UK opinion leader - page 121
- US opinion leader - page 136
- Spanish opinion leader - page 150
- Canadian opinion leader - page 166
APPENDIX A - page 180
- References - page 180
- Weblinks - page 188
APPENDIX B - page 190
- Physician sample breakdown - page 190
- The survey questionnaire - page 193
- Disclaimer - page 204

List of Tables
Table 1: Prevalence of obstructive airways disease in the UK - page 29
Table 2: Presence of respiratory symptoms in elderly patients in the UK - page 29
Table 3: Prevalence of COPD in Spain stratified by sex, tobacco consumption, and age - page 30
Table 4: Summary of COPD prevalence studies - page 33
Table 5: Disease severity classified by spirometry - page 44
Table 6: Global sales split by indication by class, 2004 - page 51
Table 7: Summary of (dis)advantages of main drug treatments - page 63
Table 8: Treatment of stable COPD according to ATS/ERS guidelines - page 72
Table 9: Prescribed drug treatments in the seven major markets, by severity - page 78
Table 10: Combivent use by disease severity, US and Europe - page 79
Table 11: Prescribing trends of theophylline in Japan - page 86
Table 12: Novel COPD therapies in clinical development - page 96
Table 13: US physician sample breakdown - page 190
Table 14: Japan physician sample breakdown - page 190
Table 15: France physician sample breakdown - page 191
Table 16: Germany physician sample breakdown - page 191
Table 17: Italy physician sample breakdown - page 191
Table 18: Spain physician sample breakdown - page 192
Table 19: UK physician sample breakdown - page 192

List of Figures
Figure 1: Percent change in age-adjusted US death rates - page 11
Figure 2: The inflammation associated with COPD involves neutrophils and alveolar macrophages - page 12
Figure 3: Differences between COPD and asthma - page 13
Figure 4: Some patients with COPD demonstrate partial reversible airflow limitation - page 14
Figure 5: COPD risk factors - page 15
Figure 6: Rate of decline in FEV1 with age - page 16
Figure 7: COPD death rate, by sex, by country, 2000 - page 17
Figure 8: Difference between male and female smoking rates by country, 1970-2000 - page 17
Figure 9: Classification of COPD disease severity - page 20
Figure 10: Lung function in COPD follows a curvilinear and fast decline - page 21
Figure 11: Age of COPD patients at diagnosis - page 21
Figure 12: Representation of the natural history of COPD - page 22
Figure 13: Average frequency of acute exacerbations by year by severity - page 24
Figure 14: % of COPD patients with comorbidity - page 25
Figure 15: COPD population estimates by disease severity by country - page 31
Figure 16: Comparision of COPD prevalence estimates - page 32
Figure 17: Percentage of daily smokers among adult population - page 34
Figure 18: Estimated COPD prevalence using smoking trends - page 35
Figure 19: Total COPD population in global market, 2005 and 2015 - page 37
Figure 20: Top five symptoms at presentation - page 38
Figure 21: COPD severity at diagnosis - page 39
Figure 22: Spirometry use by country - page 42
Figure 23: Key indicators for considering a diagnosis of COPD - page 43
Figure 24: Underdiagnosis among people under 55 years of age - page 45
Figure 25: Overview of the drug-classes used in COPD - page 52
Figure 26: Bronchodilators used in the treatment of COPD - page 53
Figure 27: Anti-inflammatories used in the treatment of COPD - page 59
Figure 28: Lung function decline in patients with severe COPD, by exacerbation frequency - page 64
Figure 29: SWOT analysis of COPD treatments - page 65
Figure 30: Rate of decline in FEV1 with age - page 66
Figure 31: Coverage of GOLD treatment guidelines - page 73
Figure 32: Comparison of guideline recommendations for the treatment of stable COPD - page 74
Figure 33: Opinion leader preferred treatment pathway - page 75
Figure 34: Reasons for not using treatment guidelines - page 76
Figure 35: Treatment patterns by disease severity - page 78
Figure 36: Use of short-acting bronchodilators versus long-acting bronchodilators by disease severity - page 80
Figure 37: Use of bronchodilators by drug class and COPD severity - page 82
Figure 38: Use of anti-inflammatories by drug class and COPD severity - page 83
Figure 39: Frequency of exacerbations and ICS use by COPD severity - page 84
Figure 40: Ranking of efficacy by drug class - page 87
Figure 41: Importance of treatment outcomes - page 88
Figure 42: Ranking of cost-effectiveness to the payer by drug class - page 89
Figure 43: Analysis of treatments by efficacy and cost-effectiveness - page 90
Figure 44: Compliance rate by drug class - page 91
Figure 45: Key challenges in COPD - page 92
Figure 46: Novel combinations treatments) - page 99
Figure 47: Comparison of guideline, current, and future treatment practice - page 100

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COPD

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