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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

Asthma: A Quest For Control

Raja Chatterjee, M.D., M.S.

Section on Pulmonary and Critical Care Medicine and

Center for Human Genomics

objectives
Objectives
  • Understand and be able to describe:
  • Epidemiology of asthma
  • Techniques for assessment of asthma
  • Therapy recommendations
slide3

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

asthma in america survey
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.

patients in the us overestimate their asthma control
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.

experience with asthma public survey
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.

a potential gap in patient provider communications
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.

slide8

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.

slide9

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.

simple goals of treatment for patients children and adults with asthma
Simple Goals of Treatment for Patients (Children and Adults) with Asthma

SLEEP

LEARN WORK

PLAY ACTIVITY

naep guidelines step wise management
NAEP GuidelinesStep-wise Management

Severe Persistent

Step-down

Moderate Persistent

Step-up

Mild Persistent

Mild Intermittent

NHLBI 1997

rules of two
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.

primary therapeutic targets
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.

am peak expiratory flow
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.

fewer asthma exacerbations with ics and salmeterol vs higher dose ics
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.

advair diskus 100 50 vs montelukast 10 mg am pre dose fev 1
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.

mean morning peak expiratory flow

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.

slide18

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.

summary
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
copd differential diagnosis the dutch hypothesis
COPD : Differential DiagnosisThe Dutch Hypothesis

Emphysema

Chronic Bronchitis

COPD

Airflow

Obstruction

Asthma / “Twitchy Airways”

objectives understand and be able to describe
Objectives: Understand and Be Able to Describe:
  • Epidemiology / Economics of COPD
  • Goals of COPD Therapy
  • COPD Therapy Guidelines
  • COPD Therapeutic choices
copd burden of disease
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
copd pathogenesis
COPD: Pathogenesis

From: GOLD, NIH, NHLBI

copd smoking
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
smokers begin as teenagers
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

smoking cessation and lung function
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

slide29

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.

copd goals of therapy
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
copd control vs physical status patients reporting well or completely controlled copd
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.

copd serevent vs atrovent vs placebo
COPD: Serevent vs Atrovent vs Placebo

From: Rennard SI, Anderson W, et al. 2001. AJRCCM 163(5):1087-92.

copd isolde fp in copd
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.

copd isolde
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

copd ics improved mortality
COPD: ICS Improved Mortality

From: Sin DD and Tu JV. AJRCCM 2001 (164):580.

copd ics and therapy failure
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.

copd summary
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
slide40

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
objectives understand and be able to describe41
Objectives: Understand and Be Able to Describe:
  • Epidemiology / Economics of COPD
  • Goals of COPD Therapy
  • COPD Therapy Guidelines
  • COPD Therapeutic choices