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Asthma: A Quest For Control

Asthma: A Quest For Control. Raja Chatterjee, M.D., M.S. Section on Pulmonary and Critical Care Medicine and Center for Human Genomics. Objectives. Understand and be able to describe: Epidemiology of asthma Techniques for assessment of asthma Therapy recommendations.

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Asthma: A Quest For Control

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  1. Asthma: A Quest For Control Raja Chatterjee, M.D., M.S. Section on Pulmonary and Critical Care Medicine and Center for Human Genomics

  2. Objectives • Understand and be able to describe: • Epidemiology of asthma • Techniques for assessment of asthma • Therapy recommendations

  3. Asthma Demographics 1999 US Population = 272.4 Million (US Census, 5/1/99); Asthma Patients = 5.5% Prevalence (ALA, 10/97) Severe 16% AA 6.6% Males 42% Age > 18 y 10 million 67% 17 million asthma patients Hispanic11.2% Moderate 31% Caucasian4.6% Prevalence Mildpersistent25% Females 57% Age < 18 y 5 million 33% Mildintermittent 28% Asthma Patients Age Severity Race Gender Asthma Physician Market Dynamics Study 3/99-10/99 National Center for Health Statistics 1982-1994 Scott Levin: PDDA, MAT 7/99 Morbidity & Mortality Weekly Report 1998 Scott Levin: PDDA, MAT 7/99

  4. Asthma in America Survey • Survey of patient, physician, and public knowledge, and attitudes and behavior toward asthma • Conducted by the public opinion research group Schulman, Ronca and Bucuvalas, Inc, in 1998 • Supported by Glaxo Wellcome • 30-minute telephone interviews with 2509 patients with asthma, randomly identified • Margin of error +/– 2% Asthma in America™ Survey. SRBI. December 1998.

  5. Patients in the US Overestimate Their Asthma Control • Of patients who report symptoms that meet NIH criteria for moderate-persistent asthma • 61% still consider their asthma to be “well controlled” or “completely controlled” • Of patients who report symptoms that meet NIH criteria for severe-persistent asthma • 32% still consider their asthma to be “well controlled” or “completely controlled” Asthma in America Survey. SRBI. December 1998.

  6. Experience With Asthma: Public Survey Family Members With Asthma 35.1% Friends/Coworkers With Asthma 29.4% Past History of Asthma 5.8% CurrentlyExperiencing Asthma 6.7% None 23.0% Base: All respondents (unweighted n=1000). Asthma in America Survey. SRBI. December 1998.

  7. A Potential Gap in Patient-Provider Communications 97 Patient 100 92 90 Doctor 83 80 70 70 55 Patients and Doctors(%) 60 35 40 28 27 20 0 Developed Prescribed Given Lung- Scheduled Shown Inhaler Use Written Action Peak Flow Function Test Follow-up Plan Meter Visits Base: All patients (unweighted n=2509), all doctors (unweighted n=512) Asthma in America Survey. SRBI. December 1998.

  8. Relative Risk of Hospitalization in the United States 2-agonists 8 Total 7 Age 0-17 6 Age 18-44 Relative Risk 5 Age 45+ 4 ICS 3 Total 2 Age 0-17 Age 18-44 1 Age 45+ 0 None 0-1 1-2 2-3 3-5 5-8 8+ Prescriptions per person-year Donahue et al. JAMA. 1997;277:887-891.

  9. Low-dose Inhaled Corticosteroids and Asthma Deaths in Canada 2.5 2.0 Rate Ratio for Deathfrom Asthma 1.5 1.0 0.5 0.0 1 2 3 4 5 6 7 8 9 10 11 12 Number of Canisters of ICS per Year Suissa et al. N Engl J Med. 2000;343:332-336.

  10. Simple Goals of Treatment for Patients (Children and Adults) with Asthma SLEEP LEARN WORK PLAY ACTIVITY

  11. NAEP GuidelinesStep-wise Management Severe Persistent Step-down Moderate Persistent Step-up Mild Persistent Mild Intermittent NHLBI 1997

  12. Rules of Two* Patients Are Candidates for Maintenance Therapy If … • They are using a quick-relief inhaler more than 2 times per week • They awaken at night due to asthma more than 2 times per month • They refill a quick-relief inhaler prescriptionmore than 2 times per year *“Rules of Two” is a trademark of the Baylor Health Care System.

  13. Primary Therapeutic Targets Smoothmuscle dysfunction Airway inflammation Long acting2-agonists Inhaledcorticosteroids • Bronchoconstriction • Bronchial hyperreactivity • Hyperplasia/hypertrophy • Inflammatory mediator release • Inflammatory cell infiltration/activation • Mucosal edema • Cellular proliferation • Epithelial damage • Basement membrane thickening Symptoms/exacerbations Adapted from Bousquet J et al. Am J Respir Crit Care Med. 2000;161:1720-1745.

  14. AM Peak Expiratory Flow FP 88 mcg +salmeterol 42 mcg b.i.d. FP 220 mcg b.i.d. * 60 * * * * 50 Mean Change in AM PEF (L/min) * 40 30 20 10 0 0 1-4 5-8 13-16 17-20 21-24 9-12 Weeks of Treatment *P < 0.001. Condemi JJ et al. Ann Allergy Asthma Immunol. 1999;82:383-389.

  15. Fewer Asthma Exacerbations* with ICS and Salmeterol vs Higher-Dose ICS Ind Greening 9 studies3685 patients Woolcock Kelsen Murray Kalberg Condemi Van Noord (LD) Van Noord (HD) Vermetten Fixed Effects † Random Effects † -20 -15 -10 -5 0 5 10 15 20 Treatment Difference (%) Favors Increasing ICS Favors Adding Salmeterol *Based on mean percentage of patients with one or more exacerbations. Studies not individually powered to examine exacerbation rates. One study used a BDP dose outside of US labeling. †P = 0.020 vs higher-dose ICS. Shrewsbury S et al. Br Med J. 2000;320:1368-1373.

  16. ADVAIR Diskus® 100/50 vsMontelukast 10 mg: AM Pre-dose FEV1 * Montelukast 10 mg ADVAIR 100/50 0.54 L * * 0.6 * * 0.5 Mean Change in FEV1 (L) 0.4 0.27 L 0.3 0.2 0.1 0 Endpoint 0 1 4 8 12 Weeks of Treatment Baseline AM predose FEV1 was 2.46 L and 2.40 L for ADVAIR and montelukast groups, respectively. *P < 0.001 vs montelukast. Calhoun WJ et al. Am J Respir Crit Care Med. 2001;164:759-763.

  17. FP 100 mcg + montelukast 10 mg Mean Morning Peak Expiratory Flow 35 * * * * * * 30 * * * * * * 25 * Mean Change from Baseline in AM PEF (L/min) 20 15 10 ADVAIR™ Diskus® 100/50 5 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Endpoint Weeks *P  0.011. Mean baseline values were 398.3 L/min for ADVAIR and 392.1 L/min for FP plus montelukast. Nelson HS et al. J Allergy Clin Immunol. 2000;106:1088-1095.

  18. Low-dose Inhaled Corticosteroids and Asthma Deaths in Canada 2.5 2.0 Rate Ratio for Deathfrom Asthma 1.5 1.0 0.5 0.0 1 2 3 4 5 6 7 8 9 10 11 12 Number of Canisters of ICS per Year Suissa et al. N Engl J Med. 2000;343:332-336.

  19. Summary • Asthma is not as well controlled as we think • Rules of 2 • 2 episodes requiring albuterol per week • 2 nocturnal awakenings per month • 2 canisters of albuterol per YEAR • STEROIDS • Add-on therapy better than increasing steroids

  20. COPD : Differential DiagnosisThe Dutch Hypothesis Emphysema Chronic Bronchitis COPD Airflow Obstruction Asthma / “Twitchy Airways”

  21. Objectives: Understand and Be Able to Describe: • Epidemiology / Economics of COPD • Goals of COPD Therapy • COPD Therapy Guidelines • COPD Therapeutic choices

  22. COPD: Burden of Disease • 4th leading cause of death in the U.S.A. • 2.74M estimated deaths worldwide (WHO, 2000) • 12th largest burden of disease in 1990 • 5th largest burden of disease in 2020 • Physician visits increased from 9.3M to 16M between 1985 and 1995 • Hospitalizations in 1995 estimated expenditures of $14.7B

  23. COPD Facts: Death Rates Compared

  24. COPD: Pathogenesis From: GOLD, NIH, NHLBI

  25. COPD: Smoking • Cigarette smoking is the primary cause of COPD • 47.2M people smoke in the U.S.A. • 28 % of all men • 23% of all women • 1.1 B smokers worldwide increasing to 1.6 B by 2025 (WHO) • Primary increase is in low- and middle-income countries

  26. Smokers Begin as Teenagers 90% of new smokers begin as teenagers; more than 5 million of whom will eventually die as a result Reprinted with permission of the American Academy of Pediatrics Source: CDC Office of Smoking and Health; National Center for Tobacco-Free Kids

  27. Smoking Cessation and Lung Function Smoking cessation is essential at all stages of the disease 100 75 50 25 0 Never smoked or notsusceptible to smoke Smoked regularlyand susceptibleto its effects Stopped at 45 FEV1 (% of value at age 25) Disability Stopped at 65 Death † † 25 50 75 Age (years) Adapted from Fletcher C, Peto R. Br Med J 1977

  28. NIH Lung Health Study: 1986-1994 Participants = 5887 82 80 78 76 74 72 1207 1067 1516 972 910 PredictedFEV1(%) 3804 3264 2864 2526 QuittersSmokers 2298 BL 1 2 3 4 5 Annual Visits Adapted from Anthonisen NR et al. JAMA. 1994;272:1497-1505.

  29. COPD: Goals of Therapy • Prevent disease progression • Relieve symptoms • Improve exercise tolerance • Improve health status • Prevent and treat exacerbations • Prevent and treat complications • Reduce mortality • Reduce side-effects of treatment

  30. COPD: GOLD Guidelines

  31. COPD: Control vs Physical StatusPatients Reporting Well or Completely Controlled COPD P15. Overall, how well would you say that your respiratory condition has been controlled in the past 12 months? Would you say it was: completely controlled, well controlled, somewhat controlled, poorly controlled, or not controlled? N=573 National Center for Health Statistics. National Health Interview Survey; 1982-1999, 1997-1998. Information cited in: American Lung Association. Trends in Chronic Bronchitis and Emphysema: Morbidity and Mortality; December 2000.

  32. COPD: Serevent vs Atrovent vs Placebo From: Rennard SI, Anderson W, et al. 2001. AJRCCM 163(5):1087-92.

  33. COPD: Tiotropium

  34. COPD: ISOLDEFP in COPD From Spencer A, Calverly PA, et al. Health status deterioration in patients with chronic obstructive pulmonary disease. AJRCCM 2001; 163:122-128.

  35. COPD: ISOLDE Exacerbations ( p = 0.026) FP group 0.99 / year Placebo 1.32 / year Health Status (p = 0.004) FP group score fell 2 units /year Placebo group score fell 3.2 units / year Withdrawal due to non-cancer respiratory disease ( p = 0.034) FP 25% Placebo 19% Safety: FP no different from placebo

  36. COPD: ICS Improved Mortality From: Sin DD and Tu JV. AJRCCM 2001 (164):580.

  37. COPD: ICS and Therapy Failure Relative Risk Between ICS Use and Risk of Rx Failure (Mean with 95% CI) From: Sin DD and Tu JV. AJRCCM 2001 (164):580.

  38. COPD: Summary • COPD is a leading cause of death • COPD is primarily caused by smoking • It’s preventable! • Diagnose early to make early interventions • Patients underestimate their level of control

  39. COPD: Summary • Goal of therapy is symptom improvement / reduction of complications • Long-acting beta agonists are an excellent first-line therapy (Serevent) • ICS are useful and beneficial in some patients • Anticholinergics are useful • Oxygen reduces mortality

  40. Objectives: Understand and Be Able to Describe: • Epidemiology / Economics of COPD • Goals of COPD Therapy • COPD Therapy Guidelines • COPD Therapeutic choices

  41. Questions ?

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