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Breathing New Life into COPD Management: GOLD Report Updates PDF Free Download

Breathing New Life into COPD Management: GOLD Report Updates PDF free Download. Think more deeply and widely.

4/2/2024
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Breathing New Life into
COPD Management:
GOLD Report Updates
Julia Young (McElyea), Pharm.D., BCACP
Clinical Assistant Professor, Dept of Pharmacy: Clinical and Admin Sciences
Integris Health Comprehensive Medication Management (CMM) Pharmacist
Oklahoma Society of
Health-System
Pharmacists (OSHP)
2024 Spring Meeting
April 19, 2024
Financial Disclosure and Resolution
Under guidelines established under the Standards for Integrity and Independence in
Accredited Continuing Education, disclosure must be made regarding relevant
financial relationships with ineligible companies within the last 24 months.
I have no relevant financial relationships with ineligible companies to disclose.
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Professional
Practice Gap
The Global Initiative for Obstructive Lung Disease (GOLD) Report
for the prevention, diagnosis, and management of COPD
documents update annually
Significant changes were made in the 2023 report (maintained in
2024 report)
Combined groups C and D of the Initial Assessment Tool into a new
group E
Dual long-acting bronchodilators, a long-acting beta-agonist
(LABA) and long-acting muscarinic antagonist (LAMA), are now
recommended for groups B and E over a single long-acting
bronchodilator
Learning
Objectives
Describe recent updates of the Global Initiative for
Obstructive Lung Disease Report
Explain the pharmacology, pharmacokinetics, and
other clinical pearls of long-acting beta agonists and
long-acting muscarinic antagonists
Select appropriate therapy based on the revised ABE
Initial Assessment Tool and whether exacerbations or
dyspnea predominate at follow-up
At the completion of this activity, pharmacists will be able to:
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Global Initiative for
Obstructive Lung
Disease Updates
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What is
GOLD?
Interprofessional organization that works with health care and
public health officials across the globe to:
1. Raise chronic obstructive pulmonary disease (COPD) awareness
2. Improve COPD prevention
3. Improve COPD treatment
Collaborates with the U.S. National Heart, Lung, and Blood
Institute and the World Health Organization
Releases annual strategy documents, commonly referred to as
the GOLD Report, to direct clinicians
Although referred to as a “guideline,” it technically is NOT due to
lacking structured processes such as the GRADE system
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org
COPD
Definition
Broadened
COPD is a heterogeneous lung condition characterized by chronic
respiratory symptoms due to abnormalities in the airways and/or
alveoli that cause persistent, progressive,airflow obstruction
Traditionally understood as a single “disease” caused by tobacco
smoking, however, other etiotypes are recognized but lack studies
• COPD-G: genetic (alpha-1 antitrypsin deficiency)
• COPD-D: developmental
• COPD-C: cigarette smoking (includes vaping and e-cigarettes)
• COPD-P: pollution
• COPD-I: infection
• COPD-A: asthma history
Little impact on clinical practice – further research needed
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org
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Prevalence,
Screening &
Presentation
Prevalence
• Estimated 14.2 million (6.5%) of U.S. adults diagnosed (2021)
• True prevalence may be more than double that amount
• Sixth leading cause of death in the U.S.
Screening
• Consider if signs/symptoms or risk factors are present
• Signs/symptoms
Dyspnea, chronic cough, sputum production
Cyanosis, barrel chest, increased respiratory rate, shallow
breathing, pursed lips during expiration
•Risk factors
Over 20 pack-years of smoking
Recurrent chest infections
Early life events/exposures
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org
Previously,
group E was split
into C and D
Initial
Assessment
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org
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Initial
Assessment
Previously, LABA +
LAMA therapy was
not considered
except in those
highly symptomatic
within what was
considered group D
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org
Initial
Treatment
Update
•Short (SABA, SAMA)- or long (LABA, LAMA)-acting bronchodilator choice is based on
its effect on breathlessness.
•If available and affordable, a LABA or LAMA is preferred except in those with very
occasional breathlessness.
Group A
• If affordable and appropriate, LABA + LAMA (as a single or multiple inhaler
treatment) is preferred.
• If preferred combination is not appropriate, there is not evidence to recommend
once lang-acting class over another for initial relief
Group B
• If available and affordable, LABA + LAMA (as a single or multiple inhaler
treatment) is preferred.
•If preferred combination is not appropriate, LAMAs may have a greater effect on
exacerbation reduction compared to LABAs.
• LABA + ICS is no longer encouraged. If an ICS is indicated, triple therapy (LABA +
LAMA + ICS) is preferred.
Group E
•Inhaled bronchodilators are recommended over oral bronchodilators.
•Those on a long-acting, should always be provided a short-acting for immediate relief
of symptoms. Combination of SABA and SAMA is superior to either medication alone.
All Groups
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org
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Rationale for
Early Dual
Long-Acting
Bronchodilator
Use Two inhaled bronchodilators may reduce exacerbations and
improve lung function, dyspnea, and health status
• High quality evidence was not specific to newly diagnosed COPD
• No evidence suggesting mortality benefits yet
Importance of reducing exacerbation risk as soon as possible
• COPD is progressive and insidious
• Once experiencing an exacerbation, patients never return to prior state
1 in 10 patients have worse spirometry 100 days after
Long term prognosis is poor after – five-year mortality rate of ~50%
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org; Hurst JR et al. N Eng J Med. 2010;363(12):1128-1138.
Figure 18a: FEV1 change from baseline, LAMA/LABA Dual therapy vs LAMA Monotherapy
References: 2023 Canadian Thoracic Society Guidelines. Pub Nov 2023. Available from 2023 Canadian Thoracic Society Guideline on Pharmacotherapy in Patients With Stable COPD -
CHEST (chestnet.org)
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Figure 18a: FEV1 change from baseline, LAMA/LABA Dual therapy vs LABA Monotherapy
References: 2023 Canadian Thoracic Society Guidelines. Pub Nov 2023. Available from 2023 Canadian Thoracic Society Guideline on Pharmacotherapy in Patients With Stable COPD -
CHEST (chestnet.org)
Rationale for
Early Dual
Long-Acting
Bronchodilator
Use Continued
•↑peak and trough forced expiratory
volume in 1 second (FEV1)
•↑St. Georges Respiratory
Questionnaire score
•↑health-related quality of life
•↓exacerbations
Significant
outcomes for
dual long-acting
bronchodilators:
• all-cause mortality
• all-cause adverse events
• serious adverse events
No difference
found:
References: Maqsood U et al. Cochrane Database Syst Rev. 2019;3(3):CD012930.
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Initial
Treatment
Update
•Short (SABA, SAMA)- or long (LABA, LAMA)-acting bronchodilator choice is based on
its effect on breathlessness.
•If available and affordable, a LABA or LAMA is preferred except in those with very
occasional breathlessness.
Group A
• If affordable and appropriate, LABA + LAMA (as a single or multiple inhaler
treatment) is preferred.
• If preferred combination is not appropriate, there is not evidence to recommend
once lang-acting class over another for initial relief
Group B
• If available and affordable, LABA + LAMA (as a single or multiple inhaler
treatment) is preferred.
•If preferred combination is not appropriate, LAMAs may have a greater effect on
exacerbation reduction compared to LABAs.
•LABA + ICS is no longer encouraged. If an ICS is indicated, triple therapy (LABA +
LAMA + ICS) is preferred.
Group E
•Inhaled bronchodilators are recommended over oral bronchodilators.
•Those on a long-acting, should always be provided a short-acting for immediate relief
of symptoms. Combination of SABA and SAMA is superior to either medication alone.
All Groups
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org; Hurst JR et al. N Eng J Med. 2010;363(12):. 1128-1138
Initial
Treatment
Update: ICS
Use
Only indicated initially if:
Blood eosinophils are > 300
Comorbid asthma (ICS is
mandatory)
See next slide for other
scenarios that ICS use is
favored
Regular treatment with ICS
increases pneumonia risk
When used, preferred as a
component of triple therapy
LABA + LAMA + ICS improved
lung function/ symptoms, and
reduced exacerbations
compared to LABA + ICS, LABA
+ LAMA, and LAMA
Great treatment effect in those
with high exacerbation risk
Continuous relationship between
blood eos and ICS effects
Abbreviations: ICS = Inhaled Corticosteroid
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org; Hurst JR et al. N Eng J Med. 2010;363(12):1128-1138.
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Initial /
Follow-Up
Assessment
#despite appropriate
use of long-acting
bronchodilator
maintenance
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org
Follow-Up
Assessment
Escalation to triple
therapy now only
being considered if
exacerbations
predominant
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org
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Teaching
Slide Set
Exacerbation
Risk
Reduction
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org
Teaching
Slide Set
Mortality
Risk
Reduction
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org
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Summary:
GOLD
Updates
The GOLD Assessment Tool has been simplified from ABCD to
ABE, where Categories C and D were combined into Category E
Patients living with COPD GOLD Categories B and E are
recommended to receive dual bronchodilator therapy
LABA + LAMA
If history of or comorbid asthma or if blood eosinophils are
> 300 cells/μL, then add ICS (i.e., triple therapy LABA + LAMA + ICS)
Other Guidelines
Regarding Triple
Therapy
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2023 Canadian Thoracic Society Guidelines
Triple therapy recommended for all at
higher exacerbation risk
Regardless of eosinophil level
Acknowledge eos > 300 has greater
benefit
Extrapolated IMPACT & ETHOS trial
results to lower risk populations with
similar symptom burden
Weak to moderate evidence of not
stepping down triple therapy
Even in lower risk populations
Concern for worsened health/lung fxn
References: 2023 Canadian Thoracic Society Guidelines. Pub Nov 2023. Available from 2023 Canadian Thoracic Society Guideline on Pharmacotherapy in Patients With Stable COPD -
CHEST (chestnet.org)
Maintenance Therapy to Reduce Symptom Burden
Certainty of Evidence
Outcome(s)Comparisons
Moderate to high
Moderate to high
Low
Dyspnea, health status, lung functionLAMA > Placebo
LABA > Placebo
LAMA ≈ LABA
Moderate to high
Moderate
Dyspnea, health status, lung function
LAMA/LABA > LAMA
LAMA/LABA > LABA
Low Dyspnea, health status, lung functionLAMA/LABA > ICS/LABA
Moderate
Moderate
Dyspnea, health status, lung function
LAMA/LABA/ICS > LAMA/LABA
LAMA/LABA/ICS > ICS/LABA
Low Dyspnea, exercise tolerance, health
status, lung function
In long-acting bronchodilator:
Roflumilast ≈ placebo
Mucolytics ≈ placebo
Theophylline ≈ placebo
Low
Dyspnea, lung function, fracturesICS ≈ placebo
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Maintenance Therapy to Reduce Exacerbations
Certainty of Evidence
OutcomeComparisons
ModerateExacerbationsLAMA or LABA > SABA or SAMA
Moderate
Exacerbations
LAMA > LABA
Moderate
Low
Exacerbations
LAMA/LABA > LAMA
LAMA/LABA > LABA
Moderate ExacerbationsLAMA/LABA > ICS/LABA
Moderate
Moderate
Exacerbations
LAMA/LABA/ICS > LAMA/LABA
LAMA/LABA/ICS > ICS/LABA
Low ExacerbationsRoflumilast > placebo
Moderate ExacerbationsN-acetylcysteine > placebo
Moderate ExacerbationsMacrolide > placebo
Low
ExacerbationsTheophylline ~ placebo
Maintenance Therapy to Reduce Mortality
Certainty of Evidence
OutcomeComparisons
ModerateMortalityICS/LABA > LAMA
Moderate MortalityLAMA/LABA/ICS > LAMA/LABA
Moderate MortalityLAMA/LABA/ICS > ICS/LABA
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Long-Acting
Bronchodilators
Pharmacology
Duration
Route
Bronchodilators
Inhaled
Short-
Acting
SAMA SABA
Long-Acting
LAMA LABA
Oral
Theophylline
Bronchodilator
Introduction
Abbreviations: LABA = long-acting βagonist; LAMA = long-acting muscarinic antagonist; SABA = short-acting βagonist; SAMA = short-acting
muscarinic antagonist
Bronchodilators are the backbone of treatment for COPD
Daily use of inhaled bronchodilators prevents and reduces COPD symptoms
Cough, dyspnea, sputum, wheezing and chest tightness, fatigue
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org; Hurst JR et al. N Eng J Med. 2010;363(12):1128-1138.
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Long-Acting
Bronchodilator
Pharmacology
LAMA:
Competitive antagonists of
ACh at muscarinic receptors
inhibition of
bronchoconstriction AND
mucus secretion
LABA:
Activate cAMP/PKA pathway
smooth muscle relaxation
Secondary actions inhibit
release of inflammatory cells
(mast cells) and broncho-
constricting neuro-
transmitters (histamine and
ACh)
References: Barnes PJ. Pulmonary Pharmacology. In: Brunton LL, Knollmann BC. eds. Goodman & Gilman's: The Pharmacological Basis of Therapeutics, 14e. McGraw Hill; 2023. Accessed
March 14, 2024. https://accesspharmacy.mhmedical.com/content.aspx?bookid=3191&sectionid=269308304.
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Long-Acting
Muscarinic
Antagonists
(LAMA)
Products
COST;
PAP?
DURATION
OF ACTION
INHALER
TYPE(S)
BRAND
NAME
GENERIC
NAME
$$;
12 hoursDPITudorzaAclidinium
$$$; ×
12-24 hoursNebulizerLonhalaGlycopyrrolate*
$$$;
24 hoursNebulizerYupelriRevefenacin
$$;
24 hoursDPI, SMISpirivaTiotropium
$$;
24 hoursDPIIncruseUmeclidinium
Abbreviations: DPI = dry powder inhaler; SMI = soft mist inhaler; PAP: Patient Assistance Program
*Glycopyrronium bromide was formerly available as dry powder inhaler (Seebri Neohaler) but discontinued March 2020
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org; Hurst JR et al. N Eng J Med. 2010;363(12):1128-1138.;
Micromedex [database]. Merative; 2023. Accessed March 14, 2024. https://www.micromedexsolutions.com
Long-Acting
Beta Agonists
(LABA)
Products
COST;
PAP?
DURATION
OF ACTION
INHALER
TYPE(S)
BRAND
NAME
GENERIC
NAME
$; ×
12 hoursNebulizerBrovanaArformoterol
$$$;
12 hoursNebulizerPerforomistFormoterol**
$;
24 hoursSMIStriverdiOlodaterol
$$;
12 hoursDPI, MDISereventSalmeterol
Abbreviations: DPI = dry powder inhaler; SMI = soft mist inhaler; PAP: Patient Assistance Program
**Also considered a fast-acting beta agonist (see next slides)
While all βagonists are similar with regards to potency and β2 selectivity they
differ in onset and duration of action
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org; Hurst JR et al. N Eng J Med. 2010;363(12):1128-1138.;
Micromedex [database]. Merative; 2023. Accessed March 14, 2024. https://www.micromedexsolutions.com
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LABA: Pharmacokinetics
DURATIONONSET OF ACTIONAGENT
Short-acting
2-6 hours< 5 minutesAlbuterol
3-6 hours5-10 minutesLevalbuterol
Long-acting
12 hours< 5 minutesFormoterol**
12 hours30 minutesSalmeterol
**Also considered a fast-acting beta agonist
References: Micromedex [database]. Merative; 2023. Accessed 24 Sept 2023. https://www.micromedexsolutions.com
Formoterol in
SMART
Therapy
Fast onset and higher max puffs per day of formoterol being
the LABA component within SMART therapy
Single Maintenance And Reliever Therapy = ICS + formoterol
Utilized in asthma – 2020 guideline update, insurance day
supply restrictions often limits use
Phase 3 study ongoing for COPD – however, current
guidelines no longer recommend ICS + LABA alone
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LABA / LAMA
Combination
Products
COST;
PAP?
DURATION
OF ACTION
INHALER
TYPE(S)
BRAND
NAME
GENERIC NAME
(LABA/LAMA)
$$; ×
12 hoursDPIDuaklirFormoterol/aclidinium
$$;
12-24 hoursMDIBevespiFormoterol/glycopyrrolate
$$;
24 hoursDPIAnoroVilanterol/umeclidinium
$$;
24 hoursSMIStioltoOlodaterol/tiotropium
Abbreviations: DPI = dry powder inhaler; SMI = soft mist inhaler; PAP: Patient Assistance Program
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org; Hurst JR et al. N Eng J Med. 2010;363(12):1128-1138.;
Micromedex [database]. Merative; 2023. Accessed March 14, 2024. https://www.micromedexsolutions.com
LABA / LAMA Combination Products Continued
Disease and Patient Outcomes Among Combination Inhaled Bronchodilator Products
QUALITY
OF LIFE
EXERCISE
ENDURANCE
COPD
SYMPTOMSPFTsAGENT
✓
Formoterol/aclidinium (Duaklir)
✓✓
Formoterol/glycopyrrolate (Bevespi)
✓✓✓
Vilanterol/umeclidinium (Anoro)
✓✓
Olodaterol/tiotropium (Stiolto)
Abbreviations: PFTs = Pulmonary Function Tests
References: DynaMed. Bronchodilators for COPD. EBSCO Information Services. Accessed March 14, 2024. https://www-dynamed-
com.webproxy2.ouhsc.edu/management/bronchodilators-for-copd
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Inhaled
Corticosteroid
Pharmacology
ICS:
Upregulate anti-inflammatory proteins and downregulate pro-
inflammatory proteins reduced inflammation/allergy
Inhibit enzymes involved in leukotriene production
May increase responsiveness of airways to β agonists
References: Barnes PJ. Pulmonary Pharmacology. In: Brunton LL, Knollmann BC. eds. Goodman & Gilman's: The Pharmacological Basis of Therapeutics, 14e. McGraw Hill; 2023. Accessed
March 14, 2024. https://accesspharmacy.mhmedical.com/content.aspx?bookid=3191&sectionid=269308304.
Triple Therapy
Combination
Products
COST;
PAP?
DURATION
OF ACTION
INHALER
TYPE(S)
BRAND
NAME
GENERIC NAME
(LABA/LAMA/ICS)
$$;
24 hoursDPITrelegyVilanterol/umeclidinium
/fluticasone furoate
$$;
12 hoursMDIBreztriFormoterol/glycopyrrola
te /budesonide
Abbreviations: DPI = dry powder inhaler; SMI = soft mist inhaler; PAP: Patient Assistance Program
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org; Hurst JR et al. N Eng J Med. 2010;363(12):1128-1138.;
Micromedex [database]. Merative; 2023. Accessed March 14, 2024. https://www.micromedexsolutions.com
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Potential
Adverse
Effects
LAMA
• Anticholinergic
effects (dry
mouth, blurred
visi0n)
• Bitter metallic
taste
•Cough
LABA
• Tremor (high
doses)
•Tachycardia
• Hypokalemia,
hypomagnesemia
(rare)
•Cough
(indacaterol)
ICS
• Oral candidiasis
or thrush
• Hoarseness
•Cough
• Upper respiratory
infections
• Stunted growth
(minimal)
•Fractures (high
doses)
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org; Hurst JR et al. N Eng J Med. 2010;363(12):1128-1138.;
Micromedex [database]. Merative; 2023. Accessed March 14, 2024. https://www.micromedexsolutions.com
Inhalation
Device Type
There is no superiority of one device/formulation over another if
patients are using the devices correctly.
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Teaching
Slide Set
Inhalation
Device
Type
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org
Teaching
Slide Set
Inhalation
Device
Type
References: Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec 2023. Available from www.goldcopd.org
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Conclusion
and Clinical
Pearls
GOLD Initial Assessment Tool has been simplified to ABE
Earlier dual bronchodilator therapy recommended
ICS therapy only recommended as a part of triple therapy
in certain instances
LAMAs inhibit bronchoconstriction and mucus production
LABAs cause smooth muscle relaxation and are relatively
similar with respect to pharmacology and potency but differ
among their duration of action
LABA/LAMA combinations improve spirometry, but specific
combinations have varying effects on other outcomes
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Additional
Resources
Global Initiative for Obstructive Lung Disease (GOLD) 2024
Report. Available from 2024 GOLD Report - Global Initiative
for Chronic Obstructive Lung Disease - GOLD (goldcopd.org)
2023 Canadian Thoracic Society Guidelines. Available from
2023 Canadian Thoracic Society Guideline on
Pharmacotherapy in Patients With Stable COPD - CHEST
(chestnet.org)
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References
Barnes PJ. Pulmonary Pharmacology. In: Brunton LL, Knollmann BC. eds.
Goodman & Gilman's: The Pharmacological Basis of Therapeutics, 14e.
McGraw Hill; 2023.
https://accesspharmacy.mhmedical.com/content.aspx?bookid=3191&section
id=269308304.
DynaMed. Bronchodilators for COPD. EBSCO Information Services. https://
www.dynamed-com.webproxy2.ouhsc.edu/management/bronchodilators-
for-copd
Global Initiative for Obstructive Lung Disease (GOLD) 2024 Report. Pub Dec
2023. Available from www.goldcopd.org
Hurst JR et al. N Eng J Med. 2010;363(12):1128-1138.
Maqsood U et al. Cochrane Database Syst Rev. 2019;3(3):CD012930.
Micromedex [database]. Merative;
2023. https://www.micromedexsolutions.com
2023 Canadian Thoracic Society Guidelines. Pub Nov 2023. Available from
2023 Canadian Thoracic Society Guideline on Pharmacotherapy in Patients
With Stable COPD - CHEST (chestnet.org)
Breathing New Life into
COPD Management:
GOLD Report Updates
Julia Young (McElyea), Pharm.D., BCACP
Clinical Assistant Professor, Dept of Pharmacy: Clinical and Admin Sciences
Integris Health Comprehensive Medication Management (CMM) Pharmacist
Oklahoma Society of
Health-System
Pharmacists (OSHP)
2024 Spring Meeting
April 19, 2024
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