December 14, 2009

COPD: Diagnosis, Treatment, and H1N1 Influenza Prevention

Clinician Outreach and Communication Activity (COCA) Conference Call

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In compliance with continuing education requirements, all presenters must disclose any financial or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters as well as any use of unlabeled product(s) or product(s) under investigational use.

CDC, our planners, and our presenters wish to disclose they have no financial interests or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters with the exception of Dr. Thomashow and he wishes to disclose receiving an honorarium for speaking from Boehringer Ingelheim, Pfizer, GlaxoSmithKline and Astra Zeneca and Dr. Mannino and he wishes to disclose receiving an honoraria and research support from GlaxoSmithKline and Pfizer, receiving an honoraria for being on the advisory board and serving as a speaker for Astra-Zeneca and Dey as well as receiving research support from Novartis.

There is no commercial support.

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Chronic Obstructive Pulmonary Disease: Diagnosis and Treatment

David M. Mannino, M.D.

University of Kentucky, College of Public Health

Byron Thomashow, M.D.

Columbia University College of Medicine

Chronic Bronchitis Emphysema

Asthma

IrreversibleAirflow Obstruction

ReversibleAirflow Obstruction

Friedlander et al, COPD 2007; 4: 355-384

COPD Phenotypes (NEW)

ClinicalDyspneaFrequent ExacerbatorLow BMIPulmonary CachexiaICS-responsiveDepression and AnxietyNon-smokers

PhysiologicAirflow limitationRapid declinerBD-responsivenessHyperrresponsivenessHypercapneicPoor exercise toleranceHyperinflationLow DLCOPulmonary hypertension

RadiologicEmphysemaAirways disease

COPD Prevalence, by Sex, in US, 1980–2000(Self-Reported Emphysema or Chronic Bronchitis)

Mannino DM, et al. MMWR. 2002; 51(SS-6):1–20.

0

1

2

3

4

5

6

7

8

1980 1985 1990 1995 2000

Men Women

Millions of adults aged 25 and older

COPD Deaths by SexUS, 1980 –2000

Mannino DM, et al. MMWR. 2002; 51(SS-6):1–20.

0

10

20

30

40

50

60

70

1980 1985 1990 1995 2000

Men Women

Deaths x 1,000 among adults age 25 and older

NHANES III Current Diseases as a Proportional Venn Diagram.NHANES III Current Diseases as a Proportional Venn Diagram.

Soriano et al. Soriano et al. ChestChest. 2003;124:474-481.. 2003;124:474-481.

Diagnosed Lung Disease and Lung Function Impairment in the US Adult Population

AsthmaAsthma 5.5%5.5%

Chronic bronchitisChronic bronchitis 3.2%3.2%

EmphysemaEmphysema 1.5%1.5%

Airflow obstruction int.Airflow obstruction int. 1.6%1.6%

Airflow obstruction ext.Airflow obstruction ext. 3.1%3.1%NHANES IIINHANES III

COPD Progression and Death

Fletcher et al, The Natural History of Chronic Bronchitis and Emphysema, 1976

Adapted from Fletcher and Peto, Burrows

Natural History of Chronic Airflow Obstruction

Baraldi et al, NEJM 2007

0

20

40

60

80

100

120

FEV1/FVC < 70% FEV1/FVC => 70%

Lung Function Categories

Gold 3

Gold 2 Restricted

Gold 0 (if symptoms)or Normal

Gold 1

FEV1 % predicted

Gold 4

Years

121086420

Su

rviv

al

1.0

.9

.8

.7

.6

Survival by Lung Function Impairment

GOLD 3 or 4

GOLD 2

GOLD 0

Normal

Restricted

GOLD 1

Mannino et al, Resp Med, 2006

0 10 20 30 40 50

GOLD 3/4

GOLD 2

GOLD 1

GOLD 0

Restricted

Normal

COPD ASCVD Lung Cancer Other

Mannino et al, Resp Med, Jan 2006

What do COPD Patients Die From? (rate per 1,000 person-years)

Current Smokers Former Smokers Never Smokers

Mannino DM, Watt G, Hole D, et al Eur Respir J. 2006;27:627-643.

COPD – Disease Burden in U.S.

Life Expectancy from Age 65 (Data from NHANES 3 Follow-up)

Females

Survival in GOLD 3/4 COPD By Smoking Status

Follow-up in Years

20100

Pro

po

rtio

n S

urv

ivin

g

1.0

.8

.6

.4

.2

0.0

Survival Among Subjects with GOLD 3 or 4 COPD

Never Smokers

Former Smokers

Current Smokers

From NHANES I follow-up

Smoking and GOLD 2+ COPD in NHANES 3

Life time Asthma and GOLD 2+ COPD Findings from NHANES 3

Per

cent

wit

h C

OP

D

Influence of vapor, dust, gas or fume exposure on COPD prevalence

0

5

10

15

20

25

COPD, Emphysema

Never Smoker/No Exposure Never Smoker/ Yes ExposureEver Smoker/ No Exposure Ever Smoker/ Yes Exposure

Percent of Subjects reporting COPD or Emphysema (n=2061 US adults aged 55-75)

Trupin et al, ERJ 2003; 22:462-469

From the ATS/ERS Guidelines

Adapted from Fletcher et al. BMJ. 1977;1:1645-1648 (B).

Lung Function Over Time

Never smoked or notsusceptible to smoke

Stopped smoking at 45

(mild COPD)

Stopped smoking at 65 (severe COPD)

Death

Disability

Smoked regularly and susceptible to effects of smoking

Age (years)50 7525

Symptoms

0

25

50

100

75

FE

V1

(%)

Rel

ativ

e to

Ag

e 25

When to Perform Spirometry:Diagnosis of COPD (GOLD Guidelines)

Executive Summary: Global Strategy for the Diagnosis, Management, and Prevention of COPD Updated 2005. Available at: http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2= 1&intId=996. Accessed June 6, 2006 (A).

Spirometry Spirometry

SymptomsExercise Impairment

Dyspnea, Wheezing Cough Sputum

SymptomsExercise Impairment

Dyspnea, Wheezing Cough Sputum

ExposureTobacco

OccupationalPollution

ExposureTobacco

OccupationalPollution

Spirometry Underused in Primary CareSpirometry Underused in Primary Care

Patient history and physical findings are not enough to accurately diagnose COPD

Only 1/3 of patients with COPD have undergone spirometry as part of their diagnosis1,2

Spirometry use decreases with increasing age– ≥75 years old vs all other age groups: 25.4% vs 32.7% (P<.0001)1

– Odds ratio (95% CI) of spirometry compared with patients age 50-59: Age 60-69, 0.82 (0.78-0.86); Age 70-79, 0.68 (0.65-0.71); Age 80+, 0.52 (0.49-0.55)2

1. Han MK et al. Chest. 2007;132:403-409.

2. Lee TA et al. Chest. 2006;129:1509-1515.

GOLD Therapy at Each Stage of COPDGOLD Therapy at Each Stage of COPD

• FEV1/FVC <0.70

• FEV1 ≥80% predicted

I: Mild II: Moderate III: Severe IV: Very Severe

• FEV1/FVC <0.70

• 50% ≤FEV1 <80% predicted

• FEV1/FVC <0.70

• 30% ≤FEV1 <50% predicted

• FEV1/FVC <0.70

• FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure

Add regular treatment with one or more long-acting bronchodilators (when needed):Add pulmonary rehabilitation

Add inhaled glucocorticosteroids if repeated exacerbations

Add long-term oxygen if chronic respiratory failureConsider surgical treatments

Global Initiative for Chronic Obstructive Lung Disease (GOLD). NHLBI/WHO Workshop report. www.goldcopd.com

Effects of Bronchodilators on Clinical Outcomes in Patients With COPD

Agent FEV1

Lung Volume Dyspnea HRQL*

Exercise Tolerance*

Disease Modifier by FEV1 Side Effects

Short-acting beta2-agonists

Yes Yes Yes N/A Yes N/A Minimal

Short-acting anticholinergic

Yes Yes Yes No Yes No Minimal

Long-acting beta2-agonists

Yes Yes Yes Yes Yes No Minimal

Long-acting anticholinergic

Yes Yes Yes Yes Yes No Minimal

Theophylline Yes Yes Yes Yes Yes N/A Potentially important

*Although the results from a number of drug studies are not uniform, many of the drugs studied provide these results. N/A=evidence not available.Adapted from Celli et al. Eur Respir J. 2004;23:932-946.

OPTIMAL STUDYTiotropium plus Fluticasone/Salmeterol

Combination did not significantly decrease exacerbations compared to Tio alone

Combination: Improved lung function

Combination: Improved quality of life

Combination: Decreased COPD hospitalizations

Combination: Decreased all cause hospitalizations

Aaron et al Annals Internal Med 2007;146:1-14

COPD: The Vicious Cycle

Cooper. Cooper. Med Sci Sports Exerc.Med Sci Sports Exerc. 2001;33(7 Suppl):S643-646. 2001;33(7 Suppl):S643-646.

Chronic Pulmonary DiseaseChronic Pulmonary Disease

Physical Physical DeconditioningDeconditioning

Physical Physical ReconditioningReconditioning

Decreased Decreased Exercise Exercise CapacityCapacity

Increased Increased Exercise Exercise CapacityCapacity

Increased Increased BreathlessnessBreathlessness

Decreased Decreased BreathlessnessBreathlessness

ImmobilityImmobility Pulmonary RehabilitationPulmonary Rehabilitation

Increased VIncreased VEE

RequirementRequirementDecreased VDecreased VEE

RequirementRequirement

GOLD Therapy at Each Stage of COPDGOLD Therapy at Each Stage of COPD

• FEV1/FVC <0.70

• FEV1 ≥80% predicted

I: Mild II: Moderate III: Severe IV: Very Severe

• FEV1/FVC <0.70

• 50% ≤FEV1 <80% predicted

• FEV1/FVC <0.70

• 30% ≤FEV1 <50% predicted

• FEV1/FVC <0.70

• FEV1 <30% predicted or FEV1 <50% predicted plus chronic respiratory failure

Add regular treatment with one or more long-acting bronchodilators (when needed):Add pulmonary rehabilitation

Add inhaled glucocorticosteroids if repeated exacerbations

Add long-term oxygen if chronic respiratory failureConsider surgical treatments

Global Initiative for Chronic Obstructive Lung Disease (GOLD). NHLBI/WHO Workshop report. www.goldcopd.com

Oxygen reduces mortality in COPD patients with resting hypoxemia

CumulativeSurvival

(%)

COT = continuous oxygen therapy; NOT = nocturnal oxygen therapy; MRC controls = no oxygen therapy; MRC = domiciliary oxygen therapy.Flenley DC. Resp Care. 1983;2S:876.

Months

NIHCOT

MRCO2

NIHNOT

MRCcontrols

0

10

20

30

40

50

60

70

80

90

100

0 10 20 30 40 50 60 70

Lung volume reduction surgery is appropriate in subgroups of COPD

All PatientsAll Patients

N = 1218N = 1218

High Risk PatientsHigh Risk Patients

N = 140N = 140

Non High Risk Non High Risk PatientsPatients

N = 1078N = 1078

Upper LobeUpper Lobe

High ExerciseHigh Exercise

N = 419N = 419

Upper LobeUpper Lobe

Low ExerciseLow Exercise

N = 290N = 290

Non Upper Non Upper LobeLobe

Low ExerciseLow Exercise

N = 149N = 149

Non Upper Non Upper LobeLobe

High ExerciseHigh Exercise

N = 220N = 220

LVRS

LVRS

Defined as an acute change in dyspnea, cough and/or sputum sufficient enough to warrant therapy change1

In a 12-month observational study (n=127), 77% of patients reported having at least one exacerbation2*

The prevention of exacerbations is recognized as a key goal in COPD disease state management3

1. American Thoracic Society/European Respiratory Society. Standards for the diagnosis and management of patients with COPD [Internet]. Version 1.2. www.thoracic.org/go/copd. Accessed April 30, 2008.

2. O’Reilly, et al. Prim Care Respir J. 2006;15:346-353.3. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic

obstructive pulmonary disease – Updated 2007. www.goldcopd.org. Accessed April 30, 2008.

COPD Exacerbations

*Based on diary records of symptom-defined and healthcare-defined exacerbations.

20%-24%20%-24%(1 year)(1 year)

2.5%-10%2.5%-10%(5 days)(5 days)

22%-32%22%-32%(14 days)(14 days)

13%-33%13%-33%(14 days)(14 days)

Hospital mortalityHospital mortality

Hospital mortalityHospital mortality

Relapse (repeat ER visit)Relapse (repeat ER visit)

Treatment failure rateTreatment failure rate

Outcome of COPD Exacerbations

Seneff et al. JAMA. 1995; 274:1852-1857; Murata et al. Ann Emerg Med. 1991;20:125-129; Adams et al. Chest. 2000; 117:1345-1352; Patil et al. Arch Int Med. 2003; 163:1180-1186.

In hospitalized In hospitalized patientspatients

In ER patientsIn ER patients

In ICU patientsIn ICU patients

In outpatientsIn outpatients

Health Status Changes Following an Exacerbation

30

35

40

45

50

55

60

4 Weeks 12 Weeks 26 Weeks

65

No Further Exacerbation

Baseline(At presentation with acute exacerbation)

Further ExacerbationWithin 6 Months

SG

RQ

Sc

ore

Spencer et al. Thorax. 2003;58:589-593 (A).

COPD ExacerbationsPreventative Measures

Long acting bronchodilators

Inhaled corticosteroids

Phosphodiesterase inhibitors

Mucolytics/Antioxidants

Immunizations-influenza vaccine pneumococcal vaccine

OM-85(Broncho-vaxim)

Macrolides

Case management

Lung Volume Reduction Surgery

COPD: High Risk For Flu Complications

•Aging immune system•On inhaled and oral steroids•Multiple co-morbidities•Impaired airway defenses•Reduced lung reserve

COPD and the Flu

•Everyone with COPD should get vaccinated against the seasonal flu.•Everyone with COPD should get the pneumococcal polysaccharide vaccine (PPSV).•Everyone with COPD should get vaccinated for the 2009 H1N1 influenza, using the shot (injectable) form.

COPD and the Flu

•Persons with COPD should not get the live attenuated nasal spray flu vaccines (i.e., FluMist).

•The inactivated 2009 H1N1 influenza vaccine can be administered at the same visit as any other vaccine, including the PPSV.

COPD ExacerbationsTherapy

Bronchodilators

Systemic steroids

Antibiotics

Oxygen

Noninvasive Positive Pressure Ventilation

Intubation

www.LearnAboutCOPD.org

Chronic Obstructive Pulmonary Disease

COPD is a PREVENTABLE and TREATABLE disease

ATS/ERS Guidelines for the Treatment of COPD, 2004

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