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 2014 by the author
“COPD and new
treatment options: the
role of primary care’’
Professor of Primary Care Research
Southampton University, UK
ERS 2014
Disclosures
• Speaker’s honoraria: Astra Zeneca, Boehringer
Inglehiem, Aerocrine, Teva and GSK.
• Advisory panels: Aerocrine, Almirall,
Zeneca, BI, Chiesi, GSK, MSD, Novartis
Astra
• Sponsorship: GSK, Astra Zeneca, Mundipharma,
Aerocrine, BI
3
Role of Primary Care in COPD treatment
• Primary care has a central and fundamental role in COPD
• Most patients present initially to Primary Care for diagnosis
and management
• Many patients are treated only in primary care
• Primary care decides on who needs specialist assessment
• Most exacerbations present to primary care
• Even those under specialist care need Intergrated Care:
Coordination of care, co-morbidities
4
New Treatments for COPD
• What new treatment options do we have?
• Pharmacotherapy
– New drug classes, new versions of existing classes,
new combinations
– New ways of using medicines- new GOLD strategy
and risk stratification
•
Non-pharmacological treatments:
– Smoking cessation, exposures, Pulmonary
rehabilitation, vaccination, ventilatory support, surgery
• Management of co-morbidities
5
Global Strategy for Diagnosis, Management and Prevention of COPD
Therapeutic Options: COPD Medications
Beta2-agonists
Short-acting beta2-agonists
Long-acting beta2-agonists
Anticholinergics
Short-acting anticholinergics
Long-acting anticholinergics
Combination short-acting beta2-agonists + anticholinergic in one inhaler
Combination long-acting beta2-agonists + anticholinergic in one inhaler
Methylxanthines
Inhaled corticosteroids
Combination long-acting beta2-agonists + corticosteroids in one inhaler
Systemic corticosteroids
Phosphodiesterase-4 inhibitors
© 2014 Global Initiative for Chronic Obstructive Lung Disease
Global Strategy for Diagnosis, Management and Prevention of COPD
Therapeutic Options: Phosphodiesterase4 Inhibitors
 In patients with severe and very severe COPD



(GOLD 3 and 4) and a history of
exacerbations and chronic bronchitis, the
phospodiesterase-4 inhibitor, roflumilast,
reduces exacerbations treated with oral
glucocorticosteroids.
Oral, anti-inflammatory
Always with a long acting bronchodilator
Limited role in Primary Care
© 2014 Global Initiative for Chronic Obstructive Lung Disease
New versions of existing
treatments classes
• LABAs
– ‘Ultra-long acting’- once daily
– ? Incremental benefits over twice daily treatment
• LAMAs
– Now other drugs in class, once and twice daily
• ICS-LABA combination
– ICS Only licensed as combination therapy
– New molecule: FF, ?dose equivalence
• LABA-LAMA combinations
– ‘Dual bronchodilators’
New molecules for COPD
• LAMA
– Umeclidinium
– Glycopyrronium
– Aclidinium
• LABA
– Vilanterol
– Indercaterol
– Olodaterol
• New versions of old
classes
• Pharmacological
differences
• In varying
combinations- ICSLABA, LABA-LAMA
• ICS
– Fluticasone Fuorate
9
How important are these to Primary Care?
• Always good to have more than one drug in class
• May be incremental benefits from new drugs in class
– Long duration of action, once daily dosing
– Potency
• Combinations simplify regimes, may lead to better
adherence
• New devices and delivery systems may be easier to use
• However- by and large benefits are class effects
• New ways of using drug classes may be most important
Global Strategy for Diagnosis, Management and Prevention of COPD
(C)
(D)
(A)
(B)
CAT < 10
mMRC 0–1
CAT > 10
mMRC > 2
3
≥2
or
> 1 leading
to hospital
admission
2
1
Symptoms
1 (not leading
to hospital
admission)
0
(Exacerbation history)
4
Risk
(GOLD Classification of Airflow Limitation))
Risk
Risk Stratification in COPD
Therapy at Each Stage of COPD
I: Mild
II: Moderate
III: Severe
IV: Very Severe
 FEV1/FVC < 70%
 FEV1/FVC < 70%
 FEV1 > 80%
predicted
 FEV1/FVC < 70%
 50% < FEV1 < 80%
predicted
 FEV1/FVC < 70%
 30% < FEV1 <
50% predicted
 FEV1 < 30%
predicted
or FEV1 < 50%
predicted plus
chronic respiratory
failure
Active reduction of risk factor(s); influenza vaccination
Add short-acting bronchodilator (when needed)
Add regular treatment with one or more long-acting bronchodilators (when needed); Add
rehabilitation
Add inhaled glucocorticosteroids if repeated exacerbations
Add long term
oxygen if chronic
respiratory failure.
Consider surgical
Global Strategy for Diagnosis, Management and Prevention of COPD
Manage Stable COPD: Pharmacologic Therapy
RECOMMENDED FIRST CHOICE
GOLD 4
D
ICS + LABA
or
LAMA
GOLD 3
ICS + LABA
and/or
LAMA
A
>2
B
GOLD 2
GOLD 1
SAMA prn
or
SABA prn
mMRC 0-1
CAT < 10
LABA
or
LAMA
mMRC > 2
CAT > 10
© 2013 Global Initiative for Chronic Obstructive Lung Disease
1
0
Exacerbations per year
C
Global Strategy for Diagnosis, Management and Prevention of COPD
Combined Assessment of COPD
Assess symptoms first
(C)
(D)
(A)
(B)
CAT < 10
CAT > 10
Symptoms
mMRC 0–1
If CAT < 10 or mMRC 0-1:
Less
Symptoms/breathlessness
(A or C)
If CAT > 10 or mMRC > 2:
More
Symptoms/breathlessness
(B or D)
mMRC > 2
Breathlessness
© 2014 Global Initiative for Chronic Obstructive Lung Disease
Global Strategy for Diagnosis, Management and Prevention of COPD
Assessment of COPD
 Assess symptoms
 Assess degree of airflow limitation
using spirometry
 Assess risk of exacerbations
Use history of exacerbations and spirometry.
Assess
comorbidities
Two exacerbations
or more within the last year
or an FEV1 < 50 % of predicted value are
indicators of high risk. Hospitalization for a COPD
exacerbation associated with increased risk of death.
© 2014 Global Initiative for Chronic Obstructive Lung Disease
Global Strategy for Diagnosis, Management and Prevention of COPD
Assessment of COPD
 Assess symptoms
Assess degree of airflow limitation using
COPD Assessment Test (CAT)
spirometry
or
Assess risk of exacerbations
Clinical
COPD Questionnaire (CCQ)
Assess comorbidities
or
mMRC Breathlessness scale
© 2014 Global Initiative for Chronic Obstructive Lung Disease
Name:
Today's Date:
How is your COPD? Take the COPD Assessment Test (CAT)
This questionnaire will help you and your healthcare professional measure the impact COPD (Chronic Obstructive Pulmonary
Disease) is having on your wellbeing and daily life. Your answers and test score, can be used by you and your healthcare
professional to help improve the management of your COPD and get the greatest benefit from treatment.
If you wish to complete the questionnaire by hand on paper, please click here and then print the questionnaire.
If you complete the questionnaire on-line, for each question, click your mouse in the box that best describes you currently.
Example:
I am very happy
I am sad
SCORE
I never cough
I cough all the time
I have no phlegm (mucus) in
my chest at all
My chest is completely full
of phlegm (mucus)
My chest does not feel tight
at all
My chest feels very tight
When I walk up a hill or one
flight of stairs I am not
breathless
When I walk up a hill or one
flight of stairs I am very
breathless
I am not limited doing any
activities at home
I am very limited doing
activities at home
I am confident leaving my
home despite my lung
condition
I am not at all confident
leaving my home because
of my lung condition
I sleep soundly
I have lots of energy
I don't sleep soundly
because of my lung
condition
I have no energy at all
Last Updated: February 23, 2010
The COPD Assessment Test and CAT logo are trademarks of the GlaxoSmithKline group of
companies.
©2009 GlaxoSmithKline.
Interpreting the
score:
<10: Low impact
10-20: Medium
impact, room for
improvement
>20: High impact:
increase therapy,
consider referral
Global Strategy for Diagnosis, Management and Prevention of COPD
Modified MRC
(mMRC)Questionnaire
© 2014 Global Initiative for Chronic Obstructive Lung Disease
Global Strategy for Diagnosis, Management and Prevention of COPD
Assess Risk of Exacerbations
To assess risk of exacerbations use history of
exacerbations and spirometry:
 Two or more exacerbations within the last
year or an FEV1 < 50 % of predicted value
are indicators of high risk.
 One or more hospitalizations for COPD
exacerbation should be considered high
risk.
© 2014 Global Initiative for Chronic Obstructive Lung Disease
What drugs are we using?
20
ICS use and GOLD recommendations (1)
100
90
Patients (%)
% Patients
80
39
52
70
ICS
62
77
60
LABA/LAMA (no
ICS)
SABA/SAMA only
83
50
40
49
No treatment
30
41
20
10
0
30
8
10
A
(n=152)
3
15
14
C
(n=13)
D
(n=604)
6
B
(n=739)
2
6
1
Total COPD
population
(n=2,225)
GOLD group
Patients were assigned to GOLD groups based ion CAT score; COPD = chronic obstructive
pulmonary disease; GOLD = Global initiative for chronic Obstructive Lung Disease; ICS =
inhaled corticosteroid; LABA = long-acting β2-agonist; LAMA = long-acting muscarinic
Small et al.
antagonist; SABA = short-acting β2 agonist; SAMA = short-acting muscarinic antagonist Eur Respir J 2012 (Abstract P2876)
GOLD and primary care
• Problems with GOLD:
– Consistency- categories vary with tool used
– Ease of use in Primary Care
– Lack of contribution of known risk factors, e.g.smoking
– Risk in group B
– Comorbidities
• Risk stratification is however valid!
22
23
Asthma and COPD
similarities and differences
Postma D et al Clin Chest Med 2014
Using drugs betterDual Bronchodilation
∆=200 mL, p<0.001
∆=80 mL, p<0.001
1.50
∆=90 mL, p<0.001
∆=70 mL, p<0.001
∆=130 mL, p<0.001
1.45
∆=120 mL, p<0.001
Trough FEV1 (L)
∆=130 mL, p<0.001
1.40
1.35
1.30
1.25
1.20
0
1.25
1.37
1.36
1.38
1.45
Placebo
Open-label
tiotropium
18 μg q.d.
Glycopyrronium
50 μg q.d.
Indacaterol
150 μg q.d.
QVA149
110/50 μg q.d.
Values are least-squares mean ± standard error
Bateman et al. Eur Respir J 2013 (epub ahead of print)
So what’s new in pharmacotherapy
• No new classes (PDE4)
• Some new ‘within-class’ treatments and delivery systems
• Some new single-inhaler combinations (LABA-LAMA)
• New concepts : in assessing patients, in using treatments
• Better understanding of how to use and target treatments
27
Comorbidities and primary care
Psychological co-morbidity and
respiratory symptoms
• Perception
• Behavior
– Over-use of rescue bronchodilators
– Non-compliance with regular medication
– At-risk behaviors (smoking, substance abuse)
• Poor self-management
• Biological effects- immunology and neurology
29
Understanding your patientpsychological co-morbidity
30
Conclusions
• Numerous new products for treating COPD in primary
care, but few new classes
• Newer versions of exiting treatments may have some
incremental benefits:
– More potent
– Longer lasting
– More convenient
• LABA-LAMA single-inhaler combinations available
• New strategies for directing treatment better
31
32
GOLD: recommendations for
initial pharmacologic treatment
(C)
GOLD 4
ICS + LABA or LAMA
(D)
ICS + LABA and/or LAMA
GOLD 3
LABA and LAMA or
LABA and PDE4-inh or
LAMA and PDE4-inh
ICS+LABA and LAMA or
ICS+LABA and PDE4-inh or
LABA and LAMA or
LAMA and PDE4-inh
GOLD 2
SABA or SAMA p.r.n.
LABA or LAMA
GOLD 1
LABA or LAMA or
SABA and SAMA
LABA and LAMA
(A)
≥2
or ≥1 leading
to hospital
admission
1 (not
leading to
hospital
admission)
0
(B)
CAT <10
(Symptoms)
CAT ≥10
mMRC 01
(Breathlessness)
mMRC ≥2
No. of exacerbations/year
GOLD classification of airflow limitation
Based on combined assessment of airflow limitation, symptoms and exacerbations
Recommended first choice
Alternative choice
CAT = COPD Assessment Test; GOLD = Global initiative for chronic Obstructive Lung Disease
LABA = long-acting β2-agonist; LAMA = long-acting muscarinic antagonist; mMRC = modified Medical
Research Council; PDE4-inh = phosphodiesterase 4 inhibitor; p.r.n. = pro re nata as needed
SABA = short-acting β2-agonist; SAMA = short-acting muscarinic antagonist
GOLD 2014