SlideShare a Scribd company logo
3www.slideshare.net/ashraf eladawy
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Pharmacological treatment of COPD
(Lots of inhalers, lots of names…)
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7
More useful to classify in terms of
classes
Children’s Healthcare of Atlanta
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10
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13
lobal Initiative for Chroniclobal Initiative for Chronic
bstructivebstructive
ungung
iseaseisease
G
O
L
D
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15
GOLD2001GOLD2001
GOLD2011GOLD2011
GOLD2017GOLD2017
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17
Road Map
18
Clinical diagnosis
Spirometry
Gold Severity stage
Drugs a/t stages
COPD: Management
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Manage Stable COPD
24
Children’s Healthcare of Atlanta
25
Role of Bronchodilators in COPD
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Expiratory flow-limitation and lung hyperinflation that are only partially reversible to
bronchodilator therapy are pathophysiological hallmarks of COPD
Children’s Healthcare of Atlanta
V
BD
 Air flowDeflation
 Improvement in flow – FEV1
 Improvement in volumes – FVC and IC
Bronchodilator therapy deflates the lung
BD = bronchodilator; V = ventilation; FEV1= forced expiratory volume in 1 second;
FVC= forced vital capacity; IC = inspiratory capacity
Children’s Healthcare of Atlanta 31
33
Approaches of COPD treatment according to
GOLD guidelines
Timeline
Unidimensional approach Multidimensional approach
GOLD 2001 GOLD 2011
1) Risk:
FEV1
Rate of exacerbations
2) Symptoms:
CAT score,
mMRC scale
36
• Looks at 3 things (combined assessment):
1) FEV1
2)Symptoms
3)History of exacerbations
Revised GOLD classification
37
38
0-1 = less breathlessness
>2 = more breathlessness
39
Cough
Sputum
Chest tightness
Walking up hill
ADLs
Leaving the house
Sleep
Energy levels
41
42
Less symptoms
High risk
Less symptoms
High risk
Less symptoms
Low risk
Less symptoms
Low risk
More symptoms
high risk
More symptoms
high risk
More symptoms
low risk
More symptoms
low risk
(GOLDClassificationofAirflowLimitation)
Risk
CAT < 10
Breathlessness
mMRC 0–1 mMRC ≥ 2
Symptoms CAT≥10
≥2
or
1 (not leading
to hospital
admission)
0
≥1 leading
to hospital
admission
GOLD 2011 Combined assessment of COPD
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46
47
GOLD2017GOLD2017
48
49
Bronchodilators
Continue , stop or
try alternative
class of
bronchodilators
Evaluate effect
Group A Group B
A long – acting bronchodilators
( LABA or LAMA )
LAMA + LABA
Persistent
Symptoms
Group C
LAMA
LAMA + LABA LABA + ICS
Further
exacerbation(s)
Group D
LAMA LAMA + LABA LABA + ICS
LAMA
+ LABA
+ ICS
Consider Roflumilast
if FEV1 50% pred.˂
And patient has
chronic bronchitis
Consider
macrolides in
former smokers
Further exacerbation(s)
Further
exacerbation(s)
Persistent
Symptoms / further
exacerbation(s)
50
51
• "This is a major revision of the GOLD document since
2011 and is a step forward for individualised COPD
management.
• The updated pharmacotherapy recommendations are
now based solely on two factors, symptoms and
exacerbation history,"
GOLD2017GOLD2017
52
Revised combined COPD assessment
• A refinement of the ABCD assessment tools is proposed that
separates spirometric grades from the “ ABCD “ groups
• ABCD groups will be derived exclusively from patient
symptoms & exacerbations history
• Spirometery in conjugation with patient symptoms &
exacerbation history remains vital for :
1) Diagnosis
2) Prognostication
3) Therapeutic approaches
53
54
55
56
 All Group A patients should be offered bronchodilators
treatment based on it’s effect on breathlessness ( this
can be either short- or long-acting bronchodilator ) .
 This should be continued if symptomatic benefits is
documented.
 if necessary, an alternative class of bronchodilator
(alternative mono bronchodilator )can be used if benefit
is not achieved with the first.
57
58
Group B
A long – acting bronchodilators
( LABA or LAMA )
LAMA + LABA
Persistent
Symptoms
59
 For Group B patients, therapy should begin with a long-
acting bronchodilator LABA or LAMA , (no evidence to
recommend one over another), and should be escalated to
two bronchodilators if breathlessness continues with
monotherapy.
 If breathlessness is severe, starting the patient on dual
long-acting bronchodilators can be considered, however if
the second therapy does not improve symptoms, the
guidelines suggest stepping down to one bronchodilator.
60
Long-Acting Bronchodilators
• LAMAs
• Block acetylcholine-
mediated
bronchoconstriction (via
M3 receptors)
– Tiotropium
– Aclidinium
– Glycopyrronium
(glycopyrrolate)
– Umeclidinium
• LABAs
• Direct relaxant activity on
airway smooth muscle
(via β2 adrenoceptors)
– Formoterol
– Salmeterol
– Indacaterol
– Oldaterol
– Vilanterol
61
LAMA
DPI HandiHaler/
SMI Respimat
Spiriva®
(tiotropium)
DPI Breezhaler Seebri®
(glycopyrronium)
DPI Genuair Eklira®
(aclidinium)
DPI Ellipta Incruse®
(umeclidinium)
LAMA inhalers for COPD
62
LAMA
DPI HandiHaler/
SMI Respimat
Spiriva®
(tiotropium)
DPI Breezhaler Seebri®
(glycopyrronium)
DPI Genuair Eklira®
(aclidinium)
DPI Ellipta Incruse®
(umeclidinium)
LAMA inhalers for COPD
63
64
65
66
LABA
DPI Diskus Serevent®
(salmeterol)
DPI Aerolizer Foradil®
(formoterol)
DPI Breezhaler Onbrez®
(indacaterol)
SMI Respimat Striverdi®
(Olodaterol)
67
68
69
Fixed-dose
combination
LABA/LAMA
DPI Ellipta Anoro®
(vilanterol/umeclidinium)
DPI Breezhaler Ultibro®
(indacaterol/glycopyrronium)
SMI Respimat Inspiolto®
(olodaterol/tiotropium)
DPI Genuair Duaklir®
(formoterol/aclidinium)
Combination LABA/LAMA inhalers for COPD
70
71
72
Group C
LAMA
LAMA + LABA LABA + ICS
Further exacerbation(s)
73
 For Group C patients, it is recommended that treatment be
started with a single long-acting bronchodilator,
preferably a LAMA (LAMA was superior to the LABA
regarding exacerbation prevention).
 A second long-acting bronchodilator or the combination of
LABA/ICS may be used for persistent exacerbations;
 The guidelines recommend LABA/LAMA as the addition of
ICS has been shown to increase pneumonia risk in some
patients.
74
Inhaled Steroids in COPD
 Exacerbation reduction when
added to LABD in placebo-
controlled trials
 Improvement in FEV1 in
combination with beta-
agonists
 Clinical trial evidence
o No reduction in COPD
progression
o No mortality reduction
 Side effect profile
o Risk of pneumonia
o Risk of osteoporosis, adrenal
suppression
o Hoarse voice
o Oral Thrush
ConsPros
Burge PS, et al. BMJ. 2000;320(7245):1297-1303.
Calverley PM, et al. NEJM. 2007;356:775-789.
Festic E, et al. AJRCCM. 2015;191:141-148.
Kaplan AG. Int J COPD. 2015;10:2535-2548.
Suissa S, et al. Eur Resp J. 2015;46:1232-1235.
75
Risk of patients with COPD developing serious pneumonia is
particularly elevated and dose-dependent with fluticasone
propionate use, and comparatively much lower with
budesonide.
Based on the latest EMA review on ICS for COPD overall the
benefits of inhaled corticosteroid medicines in treating COPD
continue to outweigh their risks
76
ICS/LABA
DPI Diskus Advair®
(Fluticasone/salmeterol)
DPI Turbuhaler Symbicort®
(Budesonide/formoterol)
DPI Ellipta Relvar®
(Fluticasone/vilanterol)
77
78
79
80
Group D
LAMA LAMA + LABA LABA + ICS
LAMA
+ LABA
+ ICS
Consider Roflumilast
if FEV1 50% pred.˂
And patient has
chronic bronchitis
Consider macrolides in
former smokers
Further exacerbation(s)
Further exacerbation(s)
Persistent
Symptoms / further
exacerbation(s)
81
 For Group D patients, a LABA/LAMA combination is
preferred as initial therapy over LABA/ICS as these patients
may be at higher risk of developing pneumonia with ICS
use.
 For patients with high blood eosinophil counts or those
with asthma-COPD overlap, LABA/ICS could be considered
first-line therapy.
82
 The GOLD Report also reinforces the role of ICS/LABA for
patients that have asthma features and/or high blood
eosinophil count, and patients who show more frequent
exacerbations.
 For the first time the GOLD Report recognises eosinophils as
a potential decision-driver for COPD treatment and
as a biomarker for risk of exacerbations and identifying ICS
responders
83
In patients who develop further exacerbations on
LABA/LAMA therapy we suggest two alternative
pathways:
1.Escalation to LABA/LAMA/ICS (Triple therapy).
2.Switch to LABA/ ICS
If LABA/ICS therapy does not positively impact
exacerbations/symptoms a LAMA can be added.
84
85
• For patients who still have exacerbations with
LABA/LAMA/ICS, the following three options can be
considered:
• 1) adding roflumilast (for patients with FEV1<50% predicted
and chronic bronchitis)
• 2) adding a macrolide (azithromycin preferred, however,
antibiotic resistance should be factored in decision-
making)
• 3) discontinuing ICS.
86
87
88
Children’s Healthcare of Atlanta
89
90
Is ICS Withdrawal or Step Down
Therapy Possible
in COPD?
91
The Role of Inhaled Steroids in COPD
Pharmacotherapy
 There is no advantage in adding ICS to bronchodilator
therapy in patients at low risk of exacerbations .
 Early observational studies suggested that simply stopping
therapy increased the risk of exacerbations. However more
recent data suggest that this may not be true if the patient is
receiving long-acting inhaled bronchodilators .
92
93
94
95
6-7 0
S
C
R
E
E
N
I
N
G
Treatment
52Week -6
ICS
(remained on triple therapy from run-in)
Stepwise ICS withdrawal
(remained on dual bronchodilator)
Run-in
Triple
therapy
12
R
A
N
D
O
M
I
S
A
T
I
O
N
ICS stepwise withdrawal Stable
treatment
Reduced to 250 µg BID
Reduced to 100 µg BID
Reduced to 0 µg (placebo)
Fluticasone propionate 12-week
withdrawal schedule
500 µg BID
18
• Tiotropium 18 µg QD
• Salmeterol 50 µg BID
• Fluticasone propionate 500 µg BID
Triple therapy
regimen
WISDOM: Study design
96
WISDOM (Withdrawal of Inhaled Steroids During
Optimised bronchodilator Management) study
97
Stepping Down ICS: A Proposed Algorithm
Kaplan AG. Int J COPD. 2015;10:2535-2548.
98
Children’s Healthcare of Atlanta
99
100
 Triple therapy may be over used in COPD patients today so ,
Constant evaluation of COPD patients and changes in
patient status over time is essential to good patient care
 Step down therapy, by stopping ICS use in patients on
triple therapy , may be considered under the right set of
conditions in selected patients
 Patients undergoing treatment step down require close
monitoring to insure no adverse effects over time,
especially COPD exacerbations, are associated with the
change in therapy.
101
102
Bronchodilators
Continue , stop or
try alternative
class of
bronchodilators
Evaluate effect
Group A
Group B
A long – acting bronchodilators
( LABA or LAMA )
LAMA + LABA
Persistent
Symptoms
Group C
LAMA
LAMA + LABA LABA + ICS
Further
exacerbation(s)
Group D
LAMA LAMA + LABA LABA + ICS
LAMA
+ LABA
+ ICS
Consider Roflumilast
if FEV1 50% pred.˂
And patient has
chronic bronchitis
Consider
macrolides in
former smokers
Further exacerbation(s)
Further
exacerbation(s)
Persistent
Symptoms / further
exacerbation(s)
103
104
 Treatment recommendations are tailored to patient needs
based only on symptoms and exacerbation history.
 For patients with only occasional symptoms, a short acting
bronchodilator, either a short-acting beta-agonist (SABA)
or a short-acting muscarinic antagonist (SAMA) is
recommended.
105
 For patients with persistent symptoms, either a (LABA) or a
(LAMA) is recommended.
 For patients with persistent symptoms on single bronchodilator
therapy, advancement to dual therapy with a LAMA plus a
LABA, or combination ICS/LABA is recommended, with a
preference given to dual-bronchodilator therapy.
106
 ICS are not recommended as monotherapy in COPD .
 ICS-containing pharmaceutical regimens no longer
recommended as first-choice treatments for COPD of any
severity .
 Combination agents containing ICS + LABA are considered
appropriate step-up therapy for patients experiencing COPD
exacerbations while taking long-acting bronchodilators.
107
 The new GOLD Strategy provides clear guidance on when
and in which patients ICS can be added or withdrawn.
 Only those who have ≥2 exacerbations/year or ≥1 leading to
hospital admission may be considered for an ICS containing
therapy after LAMA/LABA.
 In addition, the new GOLD Strategy suggests that ICS therapy
may be withdrawn safely (de-escalation path ) in people with
COPD who are in GOLD group D and stable, by using a
LAMA/LABA regimen.
108
 The updated 2017 GOLD Strategy now positions a combination
of a LAMA (long-acting muscarinic receptor antagonists ) and
a LABA (long-acting beta2-agonist), as a mainstay treatment
for people with COPD in GOLD groups B-D.
 This represents a significant change versus previous GOLD
guidelines.
109
 The GOLD Report acknowledges the potential benefits of
escalation to triple therapy for those patients who are still
exacerbating despite a LAMA/LABA or still symptomatic on
ICS/LABA .
 The GOLD Report now mentions roflumilast ( PDE-4
inhibitor ) as an additional treatment option on top of
triple therapy in patients with FEV1 <50% predicted and
chronic bronchitis who still have exacerbations .
110
 Inhaled bronchodilators preferred over oral bronchodilators
(A)
 Theophylline not recommended; only to be used if other long-
term treatments are not available or unaffordable (B)
111
112
 LAMA/LABA therapy now an essential cornerstone for
COPD treatment across the spectrum of people with COPD
in GOLD groups B-D
 Clearer guidance for physicians on which subset of
patients may benefit from the addition of ICS
The Winner of GOLD 2017
113
 GOLD 2017 represents a big win for makers of the next-
generation LAMA+LABA combination inhaler treatments.
 Once-daily combination inhalers for COPD will likely result
in better adherence, which could result in improved health
outcomes compared to those regimens requiring multiple
devices .
114
 The newest COPD combination inhalers aren't on all
formularies and will be out of financial reach for many
patients .
 The 2017 GOLD guidelines emphasizing:
 The choice of inhaler device has to be individually tailored
and will depend on access, cost, prescriber, and most
importantly the patient's ability and preference .
 In other words, the best inhaler for COPD is the one a
patient can afford, understands, agrees with and will use
regularly.
115
116
117
118
119
I cannot afford my COPD medications…
what can I do? Are there any affordable
treatment alternatives?
120
121
122
123
124
125
The Role of Health Professionals
In Tobacco Control
127

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Copd 2017

  • 1.
  • 2.
  • 4. 4
  • 5. 5 Pharmacological treatment of COPD (Lots of inhalers, lots of names…)
  • 6. 6
  • 7. 7 More useful to classify in terms of classes
  • 9. 9
  • 10. 10
  • 11. 11
  • 12. 12
  • 13. 13 lobal Initiative for Chroniclobal Initiative for Chronic bstructivebstructive ungung iseaseisease G O L D
  • 14. 14
  • 16. 16
  • 18. 18 Clinical diagnosis Spirometry Gold Severity stage Drugs a/t stages COPD: Management
  • 19. 19
  • 20. 20
  • 21. 21
  • 22. 22
  • 24. 24
  • 25. Children’s Healthcare of Atlanta 25 Role of Bronchodilators in COPD
  • 26. 26
  • 27. 27
  • 28. 28
  • 29. 29 Expiratory flow-limitation and lung hyperinflation that are only partially reversible to bronchodilator therapy are pathophysiological hallmarks of COPD
  • 30. Children’s Healthcare of Atlanta V BD  Air flowDeflation  Improvement in flow – FEV1  Improvement in volumes – FVC and IC Bronchodilator therapy deflates the lung BD = bronchodilator; V = ventilation; FEV1= forced expiratory volume in 1 second; FVC= forced vital capacity; IC = inspiratory capacity
  • 32.
  • 33. 33
  • 34.
  • 35. Approaches of COPD treatment according to GOLD guidelines Timeline Unidimensional approach Multidimensional approach GOLD 2001 GOLD 2011 1) Risk: FEV1 Rate of exacerbations 2) Symptoms: CAT score, mMRC scale
  • 36. 36 • Looks at 3 things (combined assessment): 1) FEV1 2)Symptoms 3)History of exacerbations Revised GOLD classification
  • 37. 37
  • 38. 38 0-1 = less breathlessness >2 = more breathlessness
  • 39. 39 Cough Sputum Chest tightness Walking up hill ADLs Leaving the house Sleep Energy levels
  • 40.
  • 41. 41
  • 42. 42 Less symptoms High risk Less symptoms High risk Less symptoms Low risk Less symptoms Low risk More symptoms high risk More symptoms high risk More symptoms low risk More symptoms low risk (GOLDClassificationofAirflowLimitation) Risk CAT < 10 Breathlessness mMRC 0–1 mMRC ≥ 2 Symptoms CAT≥10 ≥2 or 1 (not leading to hospital admission) 0 ≥1 leading to hospital admission GOLD 2011 Combined assessment of COPD
  • 43. 43
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  • 46. 46
  • 48. 48
  • 49. 49 Bronchodilators Continue , stop or try alternative class of bronchodilators Evaluate effect Group A Group B A long – acting bronchodilators ( LABA or LAMA ) LAMA + LABA Persistent Symptoms Group C LAMA LAMA + LABA LABA + ICS Further exacerbation(s) Group D LAMA LAMA + LABA LABA + ICS LAMA + LABA + ICS Consider Roflumilast if FEV1 50% pred.˂ And patient has chronic bronchitis Consider macrolides in former smokers Further exacerbation(s) Further exacerbation(s) Persistent Symptoms / further exacerbation(s)
  • 50. 50
  • 51. 51 • "This is a major revision of the GOLD document since 2011 and is a step forward for individualised COPD management. • The updated pharmacotherapy recommendations are now based solely on two factors, symptoms and exacerbation history," GOLD2017GOLD2017
  • 52. 52 Revised combined COPD assessment • A refinement of the ABCD assessment tools is proposed that separates spirometric grades from the “ ABCD “ groups • ABCD groups will be derived exclusively from patient symptoms & exacerbations history • Spirometery in conjugation with patient symptoms & exacerbation history remains vital for : 1) Diagnosis 2) Prognostication 3) Therapeutic approaches
  • 53. 53
  • 54. 54
  • 55. 55
  • 56. 56  All Group A patients should be offered bronchodilators treatment based on it’s effect on breathlessness ( this can be either short- or long-acting bronchodilator ) .  This should be continued if symptomatic benefits is documented.  if necessary, an alternative class of bronchodilator (alternative mono bronchodilator )can be used if benefit is not achieved with the first.
  • 57. 57
  • 58. 58 Group B A long – acting bronchodilators ( LABA or LAMA ) LAMA + LABA Persistent Symptoms
  • 59. 59  For Group B patients, therapy should begin with a long- acting bronchodilator LABA or LAMA , (no evidence to recommend one over another), and should be escalated to two bronchodilators if breathlessness continues with monotherapy.  If breathlessness is severe, starting the patient on dual long-acting bronchodilators can be considered, however if the second therapy does not improve symptoms, the guidelines suggest stepping down to one bronchodilator.
  • 60. 60 Long-Acting Bronchodilators • LAMAs • Block acetylcholine- mediated bronchoconstriction (via M3 receptors) – Tiotropium – Aclidinium – Glycopyrronium (glycopyrrolate) – Umeclidinium • LABAs • Direct relaxant activity on airway smooth muscle (via β2 adrenoceptors) – Formoterol – Salmeterol – Indacaterol – Oldaterol – Vilanterol
  • 61. 61 LAMA DPI HandiHaler/ SMI Respimat Spiriva® (tiotropium) DPI Breezhaler Seebri® (glycopyrronium) DPI Genuair Eklira® (aclidinium) DPI Ellipta Incruse® (umeclidinium) LAMA inhalers for COPD
  • 62. 62 LAMA DPI HandiHaler/ SMI Respimat Spiriva® (tiotropium) DPI Breezhaler Seebri® (glycopyrronium) DPI Genuair Eklira® (aclidinium) DPI Ellipta Incruse® (umeclidinium) LAMA inhalers for COPD
  • 63. 63
  • 64. 64
  • 65. 65
  • 66. 66 LABA DPI Diskus Serevent® (salmeterol) DPI Aerolizer Foradil® (formoterol) DPI Breezhaler Onbrez® (indacaterol) SMI Respimat Striverdi® (Olodaterol)
  • 67. 67
  • 68. 68
  • 69. 69 Fixed-dose combination LABA/LAMA DPI Ellipta Anoro® (vilanterol/umeclidinium) DPI Breezhaler Ultibro® (indacaterol/glycopyrronium) SMI Respimat Inspiolto® (olodaterol/tiotropium) DPI Genuair Duaklir® (formoterol/aclidinium) Combination LABA/LAMA inhalers for COPD
  • 70. 70
  • 71. 71
  • 72. 72 Group C LAMA LAMA + LABA LABA + ICS Further exacerbation(s)
  • 73. 73  For Group C patients, it is recommended that treatment be started with a single long-acting bronchodilator, preferably a LAMA (LAMA was superior to the LABA regarding exacerbation prevention).  A second long-acting bronchodilator or the combination of LABA/ICS may be used for persistent exacerbations;  The guidelines recommend LABA/LAMA as the addition of ICS has been shown to increase pneumonia risk in some patients.
  • 74. 74 Inhaled Steroids in COPD  Exacerbation reduction when added to LABD in placebo- controlled trials  Improvement in FEV1 in combination with beta- agonists  Clinical trial evidence o No reduction in COPD progression o No mortality reduction  Side effect profile o Risk of pneumonia o Risk of osteoporosis, adrenal suppression o Hoarse voice o Oral Thrush ConsPros Burge PS, et al. BMJ. 2000;320(7245):1297-1303. Calverley PM, et al. NEJM. 2007;356:775-789. Festic E, et al. AJRCCM. 2015;191:141-148. Kaplan AG. Int J COPD. 2015;10:2535-2548. Suissa S, et al. Eur Resp J. 2015;46:1232-1235.
  • 75. 75 Risk of patients with COPD developing serious pneumonia is particularly elevated and dose-dependent with fluticasone propionate use, and comparatively much lower with budesonide. Based on the latest EMA review on ICS for COPD overall the benefits of inhaled corticosteroid medicines in treating COPD continue to outweigh their risks
  • 76. 76 ICS/LABA DPI Diskus Advair® (Fluticasone/salmeterol) DPI Turbuhaler Symbicort® (Budesonide/formoterol) DPI Ellipta Relvar® (Fluticasone/vilanterol)
  • 77. 77
  • 78. 78
  • 79. 79
  • 80. 80 Group D LAMA LAMA + LABA LABA + ICS LAMA + LABA + ICS Consider Roflumilast if FEV1 50% pred.˂ And patient has chronic bronchitis Consider macrolides in former smokers Further exacerbation(s) Further exacerbation(s) Persistent Symptoms / further exacerbation(s)
  • 81. 81  For Group D patients, a LABA/LAMA combination is preferred as initial therapy over LABA/ICS as these patients may be at higher risk of developing pneumonia with ICS use.  For patients with high blood eosinophil counts or those with asthma-COPD overlap, LABA/ICS could be considered first-line therapy.
  • 82. 82  The GOLD Report also reinforces the role of ICS/LABA for patients that have asthma features and/or high blood eosinophil count, and patients who show more frequent exacerbations.  For the first time the GOLD Report recognises eosinophils as a potential decision-driver for COPD treatment and as a biomarker for risk of exacerbations and identifying ICS responders
  • 83. 83 In patients who develop further exacerbations on LABA/LAMA therapy we suggest two alternative pathways: 1.Escalation to LABA/LAMA/ICS (Triple therapy). 2.Switch to LABA/ ICS If LABA/ICS therapy does not positively impact exacerbations/symptoms a LAMA can be added.
  • 84. 84
  • 85. 85 • For patients who still have exacerbations with LABA/LAMA/ICS, the following three options can be considered: • 1) adding roflumilast (for patients with FEV1<50% predicted and chronic bronchitis) • 2) adding a macrolide (azithromycin preferred, however, antibiotic resistance should be factored in decision- making) • 3) discontinuing ICS.
  • 86. 86
  • 87. 87
  • 88. 88
  • 90. 90 Is ICS Withdrawal or Step Down Therapy Possible in COPD?
  • 91. 91 The Role of Inhaled Steroids in COPD Pharmacotherapy  There is no advantage in adding ICS to bronchodilator therapy in patients at low risk of exacerbations .  Early observational studies suggested that simply stopping therapy increased the risk of exacerbations. However more recent data suggest that this may not be true if the patient is receiving long-acting inhaled bronchodilators .
  • 92. 92
  • 93. 93
  • 94. 94
  • 95. 95 6-7 0 S C R E E N I N G Treatment 52Week -6 ICS (remained on triple therapy from run-in) Stepwise ICS withdrawal (remained on dual bronchodilator) Run-in Triple therapy 12 R A N D O M I S A T I O N ICS stepwise withdrawal Stable treatment Reduced to 250 µg BID Reduced to 100 µg BID Reduced to 0 µg (placebo) Fluticasone propionate 12-week withdrawal schedule 500 µg BID 18 • Tiotropium 18 µg QD • Salmeterol 50 µg BID • Fluticasone propionate 500 µg BID Triple therapy regimen WISDOM: Study design
  • 96. 96 WISDOM (Withdrawal of Inhaled Steroids During Optimised bronchodilator Management) study
  • 97. 97 Stepping Down ICS: A Proposed Algorithm Kaplan AG. Int J COPD. 2015;10:2535-2548.
  • 98. 98
  • 100. 100  Triple therapy may be over used in COPD patients today so , Constant evaluation of COPD patients and changes in patient status over time is essential to good patient care  Step down therapy, by stopping ICS use in patients on triple therapy , may be considered under the right set of conditions in selected patients  Patients undergoing treatment step down require close monitoring to insure no adverse effects over time, especially COPD exacerbations, are associated with the change in therapy.
  • 101. 101
  • 102. 102 Bronchodilators Continue , stop or try alternative class of bronchodilators Evaluate effect Group A Group B A long – acting bronchodilators ( LABA or LAMA ) LAMA + LABA Persistent Symptoms Group C LAMA LAMA + LABA LABA + ICS Further exacerbation(s) Group D LAMA LAMA + LABA LABA + ICS LAMA + LABA + ICS Consider Roflumilast if FEV1 50% pred.˂ And patient has chronic bronchitis Consider macrolides in former smokers Further exacerbation(s) Further exacerbation(s) Persistent Symptoms / further exacerbation(s)
  • 103. 103
  • 104. 104  Treatment recommendations are tailored to patient needs based only on symptoms and exacerbation history.  For patients with only occasional symptoms, a short acting bronchodilator, either a short-acting beta-agonist (SABA) or a short-acting muscarinic antagonist (SAMA) is recommended.
  • 105. 105  For patients with persistent symptoms, either a (LABA) or a (LAMA) is recommended.  For patients with persistent symptoms on single bronchodilator therapy, advancement to dual therapy with a LAMA plus a LABA, or combination ICS/LABA is recommended, with a preference given to dual-bronchodilator therapy.
  • 106. 106  ICS are not recommended as monotherapy in COPD .  ICS-containing pharmaceutical regimens no longer recommended as first-choice treatments for COPD of any severity .  Combination agents containing ICS + LABA are considered appropriate step-up therapy for patients experiencing COPD exacerbations while taking long-acting bronchodilators.
  • 107. 107  The new GOLD Strategy provides clear guidance on when and in which patients ICS can be added or withdrawn.  Only those who have ≥2 exacerbations/year or ≥1 leading to hospital admission may be considered for an ICS containing therapy after LAMA/LABA.  In addition, the new GOLD Strategy suggests that ICS therapy may be withdrawn safely (de-escalation path ) in people with COPD who are in GOLD group D and stable, by using a LAMA/LABA regimen.
  • 108. 108  The updated 2017 GOLD Strategy now positions a combination of a LAMA (long-acting muscarinic receptor antagonists ) and a LABA (long-acting beta2-agonist), as a mainstay treatment for people with COPD in GOLD groups B-D.  This represents a significant change versus previous GOLD guidelines.
  • 109. 109  The GOLD Report acknowledges the potential benefits of escalation to triple therapy for those patients who are still exacerbating despite a LAMA/LABA or still symptomatic on ICS/LABA .  The GOLD Report now mentions roflumilast ( PDE-4 inhibitor ) as an additional treatment option on top of triple therapy in patients with FEV1 <50% predicted and chronic bronchitis who still have exacerbations .
  • 110. 110  Inhaled bronchodilators preferred over oral bronchodilators (A)  Theophylline not recommended; only to be used if other long- term treatments are not available or unaffordable (B)
  • 111. 111
  • 112. 112  LAMA/LABA therapy now an essential cornerstone for COPD treatment across the spectrum of people with COPD in GOLD groups B-D  Clearer guidance for physicians on which subset of patients may benefit from the addition of ICS The Winner of GOLD 2017
  • 113. 113  GOLD 2017 represents a big win for makers of the next- generation LAMA+LABA combination inhaler treatments.  Once-daily combination inhalers for COPD will likely result in better adherence, which could result in improved health outcomes compared to those regimens requiring multiple devices .
  • 114. 114  The newest COPD combination inhalers aren't on all formularies and will be out of financial reach for many patients .  The 2017 GOLD guidelines emphasizing:  The choice of inhaler device has to be individually tailored and will depend on access, cost, prescriber, and most importantly the patient's ability and preference .  In other words, the best inhaler for COPD is the one a patient can afford, understands, agrees with and will use regularly.
  • 115. 115
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  • 119. 119 I cannot afford my COPD medications… what can I do? Are there any affordable treatment alternatives?
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  • 126. The Role of Health Professionals In Tobacco Control
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