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- Roflumilast and Azithromycin have been shown to decrease exacerbations in moderate to severe COPD patients... Thank you for this opportunity and for your time and attention..[r]

COPD Assessment and Treatment Strategies Based on the Latest

GOLD Guidelines

Steven E Lommatzsch, M.D. Pulmonary and Critical Care

Learning Objectives

 Describe the GOLD recommendations for the combined assessment of COPD

 Differentiate high risk COPD patients from low risk patients in your practice

Background

 In 1998 the Global Initiative for Chronic Obstructive Lung Disease (GOLD) was implemented to increase diagnosis and improve management and prevention of COPD

 In 2001 GOLD released ‘Global Strategy

for the Diagnosis, Management and Prevention of COPD’

 Various updates have taken into account new concepts and emerging research

How to Diagnose COPD

 Symptoms

 Shortness of breath

 Chronic cough

 Chronic sputum

 History of exposure to risk factors

 Tobacco smoke

 Home cooking/biomass fuels

Perform Spirometry

 The diagnosis of COPD relies on the demonstration of airflow limitation with post bronchodilator FEV1/FVC < 0.7

 FEV1 = Forced expiratory volume in 1st second  GOLD severity based on FEV1

GOLD Mild FEV1 ≥ 80% predicted

Is FEV1 the Best Marker for Severity Assessment of COPD?

Jones et al COPD 2009;6:59-63

Poor Health

Combined Assessment of COPD Severity

 Assessment of airflow limitation

 Assessment of symptoms

Combined COPD Assessment* Risk (GO LD S ta ge of A irflow Li mi ta tion) Risk (Exa c erba tion hi st ory ) > 0-1 (C) (D) (A) (B) mMRC 0-1 CAT < 10

3

2

1

mMRC > 2 CAT > 10

*Choose the highest risk according to GOLD stage or exacerbation history

_Symptoms

50<FEV1<80 30<FEV1<50

 There are several validated questionnaires available to assess symptoms

 GOLD recommends:

 Modified British Medical Research Council

Questionnaire (easier to use)

 COPD Assessment Test (broader coverage of impact)

Assessment of Symptoms

Modified British Medical Research Council Questionnaire (MMRC) dyspnea score

0 No shortness of breath except for strenuous exercise

1 Short of breath hurrying on level or walking up a hill

2 Have to stop when walking on level

3 Stop for breath after 100m or few minutes on level Too breathless to leave the house or to perform daily

Assessment of Symptoms COPD Assessment test (CAT)

 8 item measure of health

status

 Score -5  Impact

 <10 – low

 11-20 – medium  21-30 – high

 31 - 40 – very high

0 Cough

0 Phlegm

0 Chest tightness Short of breath on hill or

flight of stairs

5

0 Limitation in home activities

5 Confidence leaving home

0 Sleep

0 Energy

Assessment of Exacerbation Risk

 Exacerbations increase decline in lung function,

health status and the risk of death

 Greatest risk factor for future exacerbations is a history of previous exacerbations

From OLD to New Classification

 The old GOLD system of classification and

treatment made recommendations based only on the severity of lung dysfunction from spirometry (GOLD stages I – IV)

 The new GOLD system of classification and

treatment is based on an integrated approach, and considers all three: spirometry, symptoms, and

Example: Combined COPD Assessment* Risk (GO LD S ta ge of A irflow Li mi ta tion) Risk (Exa c erba tion hi st ory ) > 0-1 (C) (D) (A) (B) mMRC 0-1 CAT < 10

3

2

1

mMRC > 2

CAT > 10

*Choose the highest risk according to GOLD stage or exacerbation history

_Symptoms

50<FEV1<80

30<FEV1<50

www.goldcopd.org

• Relieve symptoms

• Prevent disease progression • Improve exercise tolerance • Improve health status

• Prevent and treat complications • Prevent and treat exacerbations • Reduce mortality

Treatment of Stable COPD

1 - Smoking Cessation

2 - Pharmacologic Treatment - Pulmonary Rehabilitation - Oxygen Therapy

1 - Smoking Cessation - Smoking cessation is a key

component to preserving lung function, and no other therapy impacts the natural disease progression more

- The most proven therapy for smoking cessation is a

multifaceted approach of support networks, nicotine replacement, and agents like bupropion and varenicline

Adapted from Fletcher CM, Peto R Br Med J 1977;1:1645 20 Age (years) Death Disability Symptoms Not Susceptible Susceptible Smokers

Stopped smoking at 45 (mild COPD)

Stopped smoking at 65 (severe COPD)

30 40 50 60 70 80 90 20

Smoking Cessation Therapy

Varenicline 2mg/day Buproprion SR

NRT Nasal Spray NRT Patch

NRT Gum

NRT Patch + Buproprion SR NRT Patch +Spray

NRT – nicotine replacement therapy

USPHS 2008 meta-analysis

33.2% 24.2% 26.7% 23.4% 19.0% 28.9% 25.8%

2 - Pharmacologic Treatment

2 - Pharmacologic Treatment

- The GOLD recommendations are guided by assessing lung function, symptoms, and exacerbations

- Appropriate therapy is dependent upon each patient’s needs and responses to

Treatment based on Combined COPD Assessment* Ris k (GO LD Classific at ion of A irflow Lim ita tion) Risk (Exa ce rbat ion history ) > 0-1 (C) (D) (A) (B) mMRC 0-1 CAT < 10

3

2

1

mMRC > 2 CAT > 10

*Choose the highest risk according to GOLD stage or exacerbation history

SAMA prn or

SABA prn

_Symptoms

50<FEV1<80 30<FEV1<50

Category A : Pharmacologic Treatment

- Short acting bronchodilators are integral to management of symptoms

- Short acting agents alone are not

recommended for patients with more

sustained daily symptoms or experiencing more frequent exacerbations

- Combination therapy results in synergistic

effects.

Treatment based on Combined COPD Assessment* Ris k (GO LD Classific at ion of A irflow Lim ita tion) Risk (Exa ce rbat ion history ) > 0-1 (C) (D) (A) (B) mMRC 0-1 CAT < 10

3

2

1

mMRC > 2 CAT > 10

*Choose the highest risk according to GOLD stage or exacerbation history

SAMA prn or

SABA prn

_Symptoms

Category B : Pharmacologic Treatment

- Long acting bronchodilators are

recommended for all patients with daily symptoms

- They are more effective for symptom relief than short-acting bronchodilators

Treatment based on Combined COPD Assessment* Ris k (GO LD Classific at ion of A irflow Lim ita tion) Risk (Exa ce rbat ion history ) > 0-1 (C) (D) (A) (B) mMRC 0-1 CAT < 10

3

2

1

mMRC > 2 CAT > 10

*Choose the highest risk according to GOLD stage or exacerbation history

SAMA prn or

SABA prn

_Symptoms

50<FEV1<80 30<FEV1<50

FEV1>80%

FEV1<30% ICS + LABA

and/or

LAMA

LABA

or

Category C & D : Pharmacologic Treatment

- These two groups are treated similarly

because of the increased exacerbation risk in both Thus, therapy attempts to decrease risk of exacerbations

- As the distinguishing feature between C and D is symptoms, the chosen therapy should be that which best relieves the patient’s

Additional Choice – Medical Management

1 - Roflumilast (phosphodiesterase-4 inhibitor) is

approved in chronic bronchitic patients with frequent exacerbations, and an FEV1 < 50%, to help decrease the exacerbation rates

Lancet 2009 Aug 29;374(9691):685-94

2 - Chronic daily Azithromycin has also been proven to decrease exacerbation rates

Chronic Azithromycin Therapy*

*Albert et al N Engl J Med 2011 Aug 25; 365:689-698

3 - Pulmonary Rehabilitation

- Physical therapy has been underutilized by providers, and it is one of the most proven interventions to help with dyspnea

- Therapy typically consist of exercise training, education, nutritional interventions, and

psychosocial support

n=93

4 - OxygenTherapy

- Oxygen therapy is the most well established intervention to afford greater survival to the COPD patient

- It is indicated once PaO2 is less than 55 mmHg, and the goal is keep sats > 88% during rest, sleep, and exertion

Oxygen Improves Survival in COPD Oxygen Improves Survival in COPD

Flenley DC Chest 1985:87:99

Lancet 1981:1:681

NOTT Trial Group Ann Intern Med

1980:16936:391

NOTT study:

COT – Continuous oxygen (17.7hr) NOT – Nocturnal oxygen

MRC trial:

O2 – “nocturnal” oxygen (15hr) Controls – no oxygen

Mortality in subjects with: Upper lobe disease and low exercise capacity

1218 severe COPD patients Assessment

– CT distribution

– Exercise performance Randomize

– Surgery

– Medical management Re-evaluate: months, yearly Assess

– Survival – Exercise

Fishman A, et al N Engl J Med 2003;348:2059-2073

Lung Volume Reduction Surgery in Emphysema: NETT trial

- The National Emphysema Treatment Trial (NETT ) - Volume Reduction Surgery (LVRS) with upper lobe predominate emphysema, FEV1 < 45% of predicted, gas trapping, no significant pulmonary hypertension, and DLCO and FEV1 values of greater than 20%

- LVRS improved functional status, physiologic parameters, and quality of life as compared to the medically managed group

- Lung Volume Reduction Surgery was shown to offer

substantial survival to those patients who had low exercise tolerance post rehabilitation

- Lung transplantation is a consideration for those patients with considerable disability despite maximal medical therapy

- Factors Include:

Age < 65 years No cancer in the last years No Hepatitis B, C, HIV No tobacco in last months No severe osteoporosis No substances abuse

Reliable support network No major organ dysfunction BMI in range (<30) No advanced coronary

disease

Treatment of Comorbidities

- It is important to remember these disorders and treat accordingly

- Cardiovascular disease (most common)

- Diabetes (especially with frequent steroid use) - Lung cancer (close to 10-fold greater in subjects

with severe COPD) - Osteoporosis

- Brief Summary of Medical

Management Assess symptoms, spirometry, and exacerbation risk to characterize each patient and individualize therapy

- Use frequency of exacerbations (> 2/yr) and/or an FEV1 < 50% of predicted to indicate higher risk patients that

should be on combination inhaled steroids/long acting b -agonist and/or long acting antimuscarinic, or a

combination