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GLOBAL INITIATIVE FOR CHRONIC OBSTRUCTIVE
LUNG DISEASE (GOLD)
2019
© 2019 Global Initiative for Chronic Obstructive Lung Disease
Brief Summary on Updates of GOLD-2019
Guidelines
© 2019 Global Initiative for Chronic Obstructive Lung Disease
A- Definition& Overview
Chronic Obstructive Pulmonary Disease
(COPD)
►COPD is currently the fourth leading
cause of death in the world.
►COPD is projected to be the 3rd
leading cause of death by 2020.
►More than 3 million people died of
COPD in 2012 accounting for 6% of
all deaths globally.
© 2019 Global Initiative for Chronic Obstructive Lung Disease
►Globally, the COPD
burden is projected to
increase in coming
decades because of
continued exposure to
COPD risk factors and
aging of the
population.
►Estimated global
prevalence of 11.7%
(95% CI 8.4%–15.0%).
►Three million deaths
annually.
Prevalence of COPD
►Usually caused by significant
exposure to noxious particles or
gases.
Causes & Risk factors:
• but other environmental exposures may
contribute such as:
► fuel exposure
►air pollution
►The main risk factor for COPD
is tobacco smoking.
COPD Definition
►Chronic Obstructive Pulmonary
Disease (COPD) is a common,
preventable and treatable disease
that is characterized by:
► Persistent respiratory
symptoms
►Airflow limitation that is due to
airway and/or alveolar
abnormalities.
• Classical definition of Chronic Bronchitis:
 Cough associated with Regular production
of Sputum for 3 or more months in 2
consecutive years.
 Chronic & progressive
dyspnea
 Cough
 Sputum production  Wheezing and chest
tightness
►Symptoms of COPD
B- Diagnosis OF COPD
© 2019 Global Initiative for Chronic Obstructive Lung Disease
►COPD should be considered in
any patient who has:
► dyspnea,
►chronic cough
►sputum production,
and/or
►History of exposure to risk
factors for the disease.
Diagnosis f COPD
Spirometry diagnosis
Spirometry is required to make the
diagnosis:
 The presence of a post-bronchodilator
FEV1/FVC < 0.70 confirms the presence of
persistent airflow limitation.
Spirometry
© 2019 Global Initiative for Chronic Obstructive Lung Disease
C- Assessment
of
COPD
ABCD assessment tool
CAT: COPD Assessment Test mMRC: modified Medical Research Council
Post-bronchodilator FEV1
© 2019 Global Initiative for Chronic Obstructive Lung Disease
COPD Assessment Test (CATTM)
© 2019 Global Initiative for Chronic Obstructive Lung Disease
Modified MRC dyspnea scale
© 2019 Global Initiative for Chronic Obstructive Lung Disease
Assessment of Exacerbation Risk
►COPD exacerbations are defined as an acute worsening of respiratory
symptoms that result in additional therapy.
►Classified as:
 Mild (treated with SABAs only)
 Moderate (treated with SABAs plus antibiotics and/or oral
corticosteroids) or
 Severe (patient requires hospitalization or visits the emergency
room). Severe exacerbations may also be associated with acute
respiratory failure.
►Blood eosinophil count may also predict exacerbation rates.
© 2019 Global Initiative for Chronic Obstructive Lung Disease
ABCD Assessment Tool
© 2019 Global Initiative for Chronic Obstructive Lung Disease
►With the new proposed scheme, the subject with 3 exacerbations in the
past year would be labelled GOLD grade 4, group D.
►The other patient, who has had no exacerbations, would be classified as
GOLD grade 4, group B.
►Consider two patients:
 Both patients with FEV1 < 30% of predicted
 Both with CAT scores of 18
 But, one with 0 exacerbations in the past year and
the other with 3 exacerbations in the past year.
• Example:
D- Management
of
COPD
“Golden Quotations & Statements from the GOLD-2019”
“Inhaled bronchodilators in COPD are central to symptom management
and commonly given on a regular basis to prevent or reduce symptoms”
“Evidence A”
“Regular and as-needed use of SABA or SAMA improves FEV1 and
Symptoms” “Evidence A”
“LABAs and LAMAs significantly improve lung function, dyspnea,
health status, and exacerbation rates” “Evidence A”
“Combination treatment with LABA (Formohale®) and LAMA
increases FEV1, and reduces symptoms compared to monotherapy”
“Evidence A”
“Combination treatment with LABALAMA reduces
exacerbations compared to monotherapy” “Evidence B”
“LAMAs have a greater effect on exacerbation reduction compared with
LABAs” “Evidence A”
“Combining bronchodilators with different mechanisms and
durations of action may increase the degree of bronchodilation
with a lower risk of side-effects compared to increasing the dose of
a single bronchodilator”
“Treatment with Formoterol (Formohale®) and Tiotropium in
separate inhalers has a bigger impact on FEV1 than either
component alone”
Recommendations of GOLD-2019
for Combination Bronchodilator
therapy
Muco-regulators and Anti-oxidant agents
“Regular treatment with
mucolytics such as
Erdosteine (MUKEMI®)
reduces the risk of
exacerbations”
“Evidence B”
© 2017 Global Initiative for Chronic Obstructive Lung Disease
© 2019 Global Initiative for Chronic Obstructive Lung Disease
Inhaled Corticosteroids (ICS):
“Long-term monotherapy with ICS is not recommended” “Evidence A”
“An ICS combined with a LABA is more effective than the individual
components in improving lung functions and reducing exacerbations
in patients with exacerbations and moderate to severe COPD”
“Evidence A”
“Regular treatment with ICS increases the risk of
Pneumonia especially in those with Severe COPD”
“Evidence A”
“Long-term use of Oral glucocorticoids has numerous side-effects
with no evidence of Benefits” “Evidence A”
 “ICS/LABA Combination
decreases exacerbations to
a greater extent than an
LABALAMA combination
at higher blood eosinophil
concentrations”
BloodEosinophilcount
Eosinophils are a type of white blood cells
(WBCs) and one of the immune system
components responsible for fighting
infections .
Along with mast cells & basophils, they
control mechanisms associated with
inflammation, allergy & asthma.
Eosinophilia is a disorder associated with Eosinophils counthigher than 500 eosinophil
cells per microliter of blood and it can result from parasitic infections, asthma, allergic-
rhinitis, eczema or malignant tumors.
GOLD-2019 Guidelines
introduced
Blood Eosinophils Count
with a cut off of
100 cells per microliter
as a Biomarker for estimating
the efficacy of
Inhaled Corticosteroids (ICS)
for the prevention of
exacerbations.
Blood Eosinophil's count as a predictor
of the ICS impact
“Blood eosinophil counts predict the magnitude
of the effect of ICS
(added on bronchodilator treatment)
in preventing future exacerbations”
“ICS containing regimens
have NO effect on
exacerbations at
a blood eosinophil count
less than
100 cells/microliter”
“This threshold can
be used to identify
patients with a low
likelihood of
treatment benefit
from ICS”
Blood Eosinophil's count as a predictor
of the ICS impact
“The threshold of a blood eosinophil count
higher than 300 cells/microliter
identify patients with the greatest likelihood
of treatment benefit with ICS”
“Blood eosinophil counts can be
used as a biomarker when making
decisions regarding ICS use”
Pharmacological treatment algorithms of stable COPD
2 Separate algorithm models
Initiation treatment Algorithm Follow-up treatment Algorithm
Based on ABCD Assessment scheme
of symptoms & exacerbation risk
For patients taking maintenance
treatment whether early after initial
treatment or after years of follow-up.
Treatment of stable COPD
© 2017 Global Initiative for Chronic Obstructive Lung Disease
© 2019 Global Initiative for Chronic Obstructive Lung Disease
Definition of abbreviations:
eos: blood eosinophil count in cells per microliter; mMRC: modified Medical Research Council
dyspnea questionnaire; CAT™: COPD Assessment Test™.
Group A
© 2017 Global Initiative for Chronic Obstructive Lung Disease
© 2019 Global Initiative for Chronic Obstructive Lung Disease
►All Group A patients should be offered bronchodilator treatment based on its
effect on breathlessness.
►This can be either a short- or a long-acting bronchodilator
(Formohale®).
Group B
© 2017 Global Initiative for Chronic Obstructive Lung Disease
© 2019 Global Initiative for Chronic Obstructive Lung Disease
► Initial therapy should consist of a long acting bronchodilator
► (LABA (Formohale®) or LAMA).
Long-acting inhaled bronchodilators (Formohale®)
are superior to
short-acting bronchodilators (taken as needed)
and are therefore recommended.
Group B
►For patients with
severe breathlessness
initial therapy with:
►two bronchodilators
may be considered.
Group C
© 2017 Global Initiative for Chronic Obstructive Lung Disease
© 2019 Global Initiative for Chronic Obstructive Lung Disease
►Initial therapy should consist of a single
long acting bronchodilator.
►In two head-to-head comparisons the
tested LAMA was superior to the LABA
regarding exacerbation prevention
therefore we recommend starting
therapy with a LAMA in this group.
Group C
Group D
© 2017 Global Initiative for Chronic Obstructive Lung Disease
© 2019 Global Initiative for Chronic Obstructive Lung Disease
►In general, therapy can be started with a LAMA as it has
effects on both breathlessness and exacerbations.
►For patients with more severe symptoms (CAT™ ≥ 20),
especially driven by greater dyspnea
LAMA/LABA may be chosen as initial treatment
where LABA/LAMA combinations showed superior
results compared to the single substances.
Group D
► ICS may cause side effects such as pneumonia, so should be used as initial therapy only
after the possible clinical benefits versus risks have been considered.
►In patients with blood eosinophil
counts ≥ 300 cells/µL .
►LABA/ICS may also be first choice in COPD
patients with a history of asthma.
Initial therapy with LABA/ICS may be the first choice
as it has the greatest likelihood of reducing
exacerbations
Group D
© 2019 Global Initiative for Chronic Obstructive Lung Disease
 If Response to initial treatment is appropriate, Maintain it.
 If NOT, consider the predominant target of
treatment:
Dyspnea OR Exacerbations
Use exacerbation pathway if both exacerbations & Dyspnea are needed to be targeted
© 2019 Global Initiative for Chronic Obstructive Lung Disease
►For patients with persistent breathlessness or exercise limitation
on long acting bronchodilator monotherapy,
 the use of two bronchodilators is recommended.
FOLLOW-UP pharmacological treatment
 Dyspnea
► For patients with persistent breathlessness or exercise limitation
on LABA/ICS treatment,
 LAMA can be added to escalate to triple therapy.
 Alternatively, switching from LABA/ICS to LABA/LAMA should be
considered if the original indication for ICS was inappropriate
© 2019 Global Initiative for Chronic Obstructive Lung Disease
► Blood eosinophil counts may identify patients with a greater
likelihood of a beneficial response to ICS.
FOLLOW-UP pharmacological treatment
 Exacerbations
 For patients with persistent exacerbations on long acting bronchodilator
monotherapy, escalation to either LABA/LAMA or LABA/ICS is recommended
► . LABA/ICS may be preferred for patients with a history or
findings suggestive of asthma.
►For patients with ≥ 2 moderate exacerbations per year or at least one
severe exacerbation requiring hospitalization in the prior year,
►LABA/ICS treatment can be considered at blood eosinophil
counts ≥ 100 cells/µL, as ICS effects are more pronounced in
patients with greater exacerbation frequency and/or severity.
FOLLOW-UP pharmacological treatment
►For patients with one exacerbation per year, a peripheral blood
level ≥ 300 eosinophils/µL identifies patients more likely to
respond to LABA/ICS treatment.
 Exacerbations
 Exacerbations
In patients who develop further exacerbations on LABA/LAMA therapy
we suggest two alternative pathways
Blood eosinophil counts < 100 cells/µL
low likelihood of a beneficial
ICS response
 Add roflumilast or azithromycin
Blood eosinophil counts ≥ 100 cells /µL,
FOLLOW-UP pharmacological treatment
 Escalating to LABA/LAMA/ICS
(A beneficial response after the addition of
ICS may be observed with higher
eosinophil counts).
By Dr. Marco Makram

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Brief summary on gold 2019 guidelines on copd

  • 1. GLOBAL INITIATIVE FOR CHRONIC OBSTRUCTIVE LUNG DISEASE (GOLD) 2019 © 2019 Global Initiative for Chronic Obstructive Lung Disease Brief Summary on Updates of GOLD-2019 Guidelines
  • 2.
  • 3. © 2019 Global Initiative for Chronic Obstructive Lung Disease
  • 5. Chronic Obstructive Pulmonary Disease (COPD) ►COPD is currently the fourth leading cause of death in the world. ►COPD is projected to be the 3rd leading cause of death by 2020. ►More than 3 million people died of COPD in 2012 accounting for 6% of all deaths globally. © 2019 Global Initiative for Chronic Obstructive Lung Disease
  • 6. ►Globally, the COPD burden is projected to increase in coming decades because of continued exposure to COPD risk factors and aging of the population.
  • 7. ►Estimated global prevalence of 11.7% (95% CI 8.4%–15.0%). ►Three million deaths annually. Prevalence of COPD
  • 8. ►Usually caused by significant exposure to noxious particles or gases. Causes & Risk factors: • but other environmental exposures may contribute such as: ► fuel exposure ►air pollution ►The main risk factor for COPD is tobacco smoking.
  • 9. COPD Definition ►Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable and treatable disease that is characterized by: ► Persistent respiratory symptoms ►Airflow limitation that is due to airway and/or alveolar abnormalities.
  • 10. • Classical definition of Chronic Bronchitis:  Cough associated with Regular production of Sputum for 3 or more months in 2 consecutive years.
  • 11.  Chronic & progressive dyspnea  Cough  Sputum production  Wheezing and chest tightness ►Symptoms of COPD
  • 12. B- Diagnosis OF COPD © 2019 Global Initiative for Chronic Obstructive Lung Disease
  • 13. ►COPD should be considered in any patient who has: ► dyspnea, ►chronic cough ►sputum production, and/or ►History of exposure to risk factors for the disease. Diagnosis f COPD
  • 14. Spirometry diagnosis Spirometry is required to make the diagnosis:  The presence of a post-bronchodilator FEV1/FVC < 0.70 confirms the presence of persistent airflow limitation.
  • 15. Spirometry © 2019 Global Initiative for Chronic Obstructive Lung Disease
  • 17. ABCD assessment tool CAT: COPD Assessment Test mMRC: modified Medical Research Council
  • 18. Post-bronchodilator FEV1 © 2019 Global Initiative for Chronic Obstructive Lung Disease
  • 19. COPD Assessment Test (CATTM) © 2019 Global Initiative for Chronic Obstructive Lung Disease
  • 20. Modified MRC dyspnea scale © 2019 Global Initiative for Chronic Obstructive Lung Disease
  • 21. Assessment of Exacerbation Risk ►COPD exacerbations are defined as an acute worsening of respiratory symptoms that result in additional therapy. ►Classified as:  Mild (treated with SABAs only)  Moderate (treated with SABAs plus antibiotics and/or oral corticosteroids) or  Severe (patient requires hospitalization or visits the emergency room). Severe exacerbations may also be associated with acute respiratory failure. ►Blood eosinophil count may also predict exacerbation rates. © 2019 Global Initiative for Chronic Obstructive Lung Disease
  • 22. ABCD Assessment Tool © 2019 Global Initiative for Chronic Obstructive Lung Disease ►With the new proposed scheme, the subject with 3 exacerbations in the past year would be labelled GOLD grade 4, group D. ►The other patient, who has had no exacerbations, would be classified as GOLD grade 4, group B. ►Consider two patients:  Both patients with FEV1 < 30% of predicted  Both with CAT scores of 18  But, one with 0 exacerbations in the past year and the other with 3 exacerbations in the past year. • Example:
  • 23. D- Management of COPD “Golden Quotations & Statements from the GOLD-2019”
  • 24. “Inhaled bronchodilators in COPD are central to symptom management and commonly given on a regular basis to prevent or reduce symptoms” “Evidence A” “Regular and as-needed use of SABA or SAMA improves FEV1 and Symptoms” “Evidence A” “LABAs and LAMAs significantly improve lung function, dyspnea, health status, and exacerbation rates” “Evidence A”
  • 25. “Combination treatment with LABA (Formohale®) and LAMA increases FEV1, and reduces symptoms compared to monotherapy” “Evidence A” “Combination treatment with LABALAMA reduces exacerbations compared to monotherapy” “Evidence B” “LAMAs have a greater effect on exacerbation reduction compared with LABAs” “Evidence A”
  • 26. “Combining bronchodilators with different mechanisms and durations of action may increase the degree of bronchodilation with a lower risk of side-effects compared to increasing the dose of a single bronchodilator” “Treatment with Formoterol (Formohale®) and Tiotropium in separate inhalers has a bigger impact on FEV1 than either component alone” Recommendations of GOLD-2019 for Combination Bronchodilator therapy
  • 27. Muco-regulators and Anti-oxidant agents “Regular treatment with mucolytics such as Erdosteine (MUKEMI®) reduces the risk of exacerbations” “Evidence B”
  • 28. © 2017 Global Initiative for Chronic Obstructive Lung Disease © 2019 Global Initiative for Chronic Obstructive Lung Disease Inhaled Corticosteroids (ICS): “Long-term monotherapy with ICS is not recommended” “Evidence A” “An ICS combined with a LABA is more effective than the individual components in improving lung functions and reducing exacerbations in patients with exacerbations and moderate to severe COPD” “Evidence A”
  • 29. “Regular treatment with ICS increases the risk of Pneumonia especially in those with Severe COPD” “Evidence A” “Long-term use of Oral glucocorticoids has numerous side-effects with no evidence of Benefits” “Evidence A”
  • 30.  “ICS/LABA Combination decreases exacerbations to a greater extent than an LABALAMA combination at higher blood eosinophil concentrations”
  • 31. BloodEosinophilcount Eosinophils are a type of white blood cells (WBCs) and one of the immune system components responsible for fighting infections . Along with mast cells & basophils, they control mechanisms associated with inflammation, allergy & asthma. Eosinophilia is a disorder associated with Eosinophils counthigher than 500 eosinophil cells per microliter of blood and it can result from parasitic infections, asthma, allergic- rhinitis, eczema or malignant tumors.
  • 32. GOLD-2019 Guidelines introduced Blood Eosinophils Count with a cut off of 100 cells per microliter as a Biomarker for estimating the efficacy of Inhaled Corticosteroids (ICS) for the prevention of exacerbations.
  • 33. Blood Eosinophil's count as a predictor of the ICS impact “Blood eosinophil counts predict the magnitude of the effect of ICS (added on bronchodilator treatment) in preventing future exacerbations” “ICS containing regimens have NO effect on exacerbations at a blood eosinophil count less than 100 cells/microliter” “This threshold can be used to identify patients with a low likelihood of treatment benefit from ICS”
  • 34. Blood Eosinophil's count as a predictor of the ICS impact “The threshold of a blood eosinophil count higher than 300 cells/microliter identify patients with the greatest likelihood of treatment benefit with ICS” “Blood eosinophil counts can be used as a biomarker when making decisions regarding ICS use”
  • 35. Pharmacological treatment algorithms of stable COPD 2 Separate algorithm models Initiation treatment Algorithm Follow-up treatment Algorithm Based on ABCD Assessment scheme of symptoms & exacerbation risk For patients taking maintenance treatment whether early after initial treatment or after years of follow-up.
  • 36.
  • 37. Treatment of stable COPD © 2017 Global Initiative for Chronic Obstructive Lung Disease © 2019 Global Initiative for Chronic Obstructive Lung Disease Definition of abbreviations: eos: blood eosinophil count in cells per microliter; mMRC: modified Medical Research Council dyspnea questionnaire; CAT™: COPD Assessment Test™.
  • 38. Group A © 2017 Global Initiative for Chronic Obstructive Lung Disease © 2019 Global Initiative for Chronic Obstructive Lung Disease ►All Group A patients should be offered bronchodilator treatment based on its effect on breathlessness. ►This can be either a short- or a long-acting bronchodilator (Formohale®).
  • 39. Group B © 2017 Global Initiative for Chronic Obstructive Lung Disease © 2019 Global Initiative for Chronic Obstructive Lung Disease ► Initial therapy should consist of a long acting bronchodilator ► (LABA (Formohale®) or LAMA).
  • 40. Long-acting inhaled bronchodilators (Formohale®) are superior to short-acting bronchodilators (taken as needed) and are therefore recommended. Group B ►For patients with severe breathlessness initial therapy with: ►two bronchodilators may be considered.
  • 41. Group C © 2017 Global Initiative for Chronic Obstructive Lung Disease © 2019 Global Initiative for Chronic Obstructive Lung Disease
  • 42. ►Initial therapy should consist of a single long acting bronchodilator. ►In two head-to-head comparisons the tested LAMA was superior to the LABA regarding exacerbation prevention therefore we recommend starting therapy with a LAMA in this group. Group C
  • 43. Group D © 2017 Global Initiative for Chronic Obstructive Lung Disease © 2019 Global Initiative for Chronic Obstructive Lung Disease
  • 44. ►In general, therapy can be started with a LAMA as it has effects on both breathlessness and exacerbations. ►For patients with more severe symptoms (CAT™ ≥ 20), especially driven by greater dyspnea LAMA/LABA may be chosen as initial treatment where LABA/LAMA combinations showed superior results compared to the single substances. Group D
  • 45. ► ICS may cause side effects such as pneumonia, so should be used as initial therapy only after the possible clinical benefits versus risks have been considered. ►In patients with blood eosinophil counts ≥ 300 cells/µL . ►LABA/ICS may also be first choice in COPD patients with a history of asthma. Initial therapy with LABA/ICS may be the first choice as it has the greatest likelihood of reducing exacerbations Group D
  • 46.
  • 47. © 2019 Global Initiative for Chronic Obstructive Lung Disease  If Response to initial treatment is appropriate, Maintain it.  If NOT, consider the predominant target of treatment: Dyspnea OR Exacerbations Use exacerbation pathway if both exacerbations & Dyspnea are needed to be targeted
  • 48.
  • 49. © 2019 Global Initiative for Chronic Obstructive Lung Disease ►For patients with persistent breathlessness or exercise limitation on long acting bronchodilator monotherapy,  the use of two bronchodilators is recommended. FOLLOW-UP pharmacological treatment  Dyspnea ► For patients with persistent breathlessness or exercise limitation on LABA/ICS treatment,  LAMA can be added to escalate to triple therapy.  Alternatively, switching from LABA/ICS to LABA/LAMA should be considered if the original indication for ICS was inappropriate
  • 50. © 2019 Global Initiative for Chronic Obstructive Lung Disease ► Blood eosinophil counts may identify patients with a greater likelihood of a beneficial response to ICS. FOLLOW-UP pharmacological treatment  Exacerbations  For patients with persistent exacerbations on long acting bronchodilator monotherapy, escalation to either LABA/LAMA or LABA/ICS is recommended ► . LABA/ICS may be preferred for patients with a history or findings suggestive of asthma.
  • 51. ►For patients with ≥ 2 moderate exacerbations per year or at least one severe exacerbation requiring hospitalization in the prior year, ►LABA/ICS treatment can be considered at blood eosinophil counts ≥ 100 cells/µL, as ICS effects are more pronounced in patients with greater exacerbation frequency and/or severity. FOLLOW-UP pharmacological treatment ►For patients with one exacerbation per year, a peripheral blood level ≥ 300 eosinophils/µL identifies patients more likely to respond to LABA/ICS treatment.  Exacerbations
  • 52.  Exacerbations In patients who develop further exacerbations on LABA/LAMA therapy we suggest two alternative pathways Blood eosinophil counts < 100 cells/µL low likelihood of a beneficial ICS response  Add roflumilast or azithromycin Blood eosinophil counts ≥ 100 cells /µL, FOLLOW-UP pharmacological treatment  Escalating to LABA/LAMA/ICS (A beneficial response after the addition of ICS may be observed with higher eosinophil counts).
  • 53. By Dr. Marco Makram