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Update on Chronic Obstructive Pulmonary Disease
(COPD): Going for GOLDLeigh Anne Hylton Gravatt, PharmD,
BCPSAssistant Professor
VCU School of Pharmacy
Financial Disclosure
I have no relevant finances to disclose.
Learning Objectives• Review the epidemiology and the financial impact
associated with Chronic Obstructive Pulmonary Disorder (COPD).
• Discuss the revised diagnostic criteria and classification system for COPD.
• Compare and contrast the literature supporting the new agents for COPD with the established therapies and define their role in the treatment of COPD.
• Design a treatment algorithm for patients with COPD using the GOLD guidelines and discuss considerations for cost, ease of administration, and long‐term outcomes for these therapies.
Chronic Obstructive Pulmonary Disease (COPD)
• Common, preventable and treatable disease that is characterized by:– Persistent respiratory symptoms– Airflow limitation
• Airway or alveolar abnormalities that are caused by significant exposure to noxious particles or gases
• Common Sx:– Dyspnea, cough and/or sputum production– Often under‐reported
• May have periods of acute worsening of respiratory symptoms, called exacerbations
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
COPD: What is the Impact?
• 4th leading cause of death in the world
• 3 million died in 2012– 6% of deaths globally
• US: 12.7 million
Lancet 2012; 380(9859): 2095‐128.PLoS Med 2006;3(11):e442. http://www.who.int/mediacentre/factsheets/fs310/en/
The Economics of COPD
• US– Direct cost: $32 billion– Indirect cost: $20.4 billion
• Those admitted to the hospital in respiratory failure due to COPD ~ 50% will die within 2 years
CEOR 2013;5:235‐45.Chest. 2002;121:1441‐8.N Engl J Med 2009;360:1418‐1428.
COPD Hospital Re‐admissions
• COPD Hospital Re‐admissions w/in 30 days: 19.6%– Estimate expense: $17 billion/year
• Correlation between COPD readmission rates and readmission rates for other conditions– CHF, AMI, CAP, CVA
• Section 3025 ACA Section 1886q : The Hospital Readmissions Reduction Program (HRRP)– CMS to decrease payments for those with excessive readmissions starting October 1st 2012
– In 2014, Re‐admissions for Acute exacerbation of COPD was added to this list
CEOR 2013;5:235‐45.Chest. 2002;121:1441‐8.N Engl J Med 2009;360:1418‐1428.Am J Respir Crit Care Med. 2017. doi:10.1164/rccm.201609‐1944OC.
COPD: Pathophysiology
Airways‐ Chronic inflammation, increased goblet cells,
mucus gland hyperplasia, fibrosis and narrowing of small airways and airway
collapse
Airways‐ Chronic inflammation, increased goblet cells,
mucus gland hyperplasia, fibrosis and narrowing of small airways and airway
collapse
Lung Parencyhema‐Destruction of respiratory
bronchioles, alveolar ducts, alveolar sacs and
alveoli
Lung Parencyhema‐Destruction of respiratory
bronchioles, alveolar ducts, alveolar sacs and
alveoli
Pulmonary Vasculature‐ Intimal hyperplasia,
smooth muscle hyperatrophy/hyperplasia,
chronic hypoxic vasoconstriction of small
pulmonary arteries
Pulmonary Vasculature‐ Intimal hyperplasia,
smooth muscle hyperatrophy/hyperplasia,
chronic hypoxic vasoconstriction of small
pulmonary arteries
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.orgLancet 2012; 379:1341‐51.https://www.drugs.com/health‐guide/images/205041.jpg
COPD Pathophysiology
• Smoking and pollutants
• Host Factors
EtiologyEtiology
•Impaired lung growthAccelerated decline
•Lung InjuryLung and Systemic Inflammation
PathobiologyPathobiology• Small airway disorders or abnormalitiesEmphysema
• Systemic effects
PathologyPathology
• Persistent airflow limitation
Airflow limitationAirflow limitation
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
COPD: Risk Factors
Childhood Resp. Infections
Age and Gender
Lung Growth and
Development
Socioeconomic Status Asthma
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
Diagnosis of COPD
SymptomsSymptoms Risk FactorsRisk
Factors SpirometrySpirometry
‐ Shortness of Breath‐ Chronic Cough‐ Sputum
‐ Host Factors‐ Tobacco‐ Occupation‐ Indoor/Outdoor Pollutants
‐ Required for diagnosis‐ Post‐bronchdilator
FEV1/FVC<0.7
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
Key Indicators for COPD Consider for ANYONE > 40 Years Old
Dyspnea ‐ Worse over time‐ Worse with exercise‐ Persistent
Chronic Cough ‐ Intermittent‐ May be unproductive‐ Recurrent wheeze
Chronic Sputum Production
Recurrent Lower Respiratory Tract Infections
History of Risk Factors
‐ Genetic, congenital or developmental‐ Tobacco use‐ Smoke from home cooking or heating fuels‐ Occupational dust, vapors, fumes, gases or other devices
FH or COPD ORChildhood Factors
‐ Low birth weight‐ Childhood respiratory infections
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
Classification of Airflow Limitation
Grade Post‐Bronchodilator FEV1 % Predicted
GOLD 1‐ Mild ≥ 80%
GOLD 2‐ Moderate 50‐81%
GOLD 3‐ Severe 30‐49%
GOLD 4‐ Very Severe < 30%
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
Symptom and Airflow AssessmentModified British Medical Research Council (mMRC) Questionnaire COPD Assessment Test (CAT)
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
Revised Classification System
CC DD
AA BB
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
mMRC 0‐1 mMRC ≥ 2
CAT < 10 CAT ≥ 10
Symptoms
Exacerbation History
≥ 2 or ≥ 1 leading to hospital admission
0‐1 (Not leading to Hospital Admission)
SpirometryAssessment was removed
What’s your Letter Grade?
• Pt. with an FEV1< 45%• Pt. only has trouble with SOB when walking quickly or uphill
• She has had 1 COPD exacerbation in the last year that was treated as an outpatient
Grade Post‐Bronchodilator FEV1
Gold 1 FEV1≥ 80% predicted
Gold 2 50% ≤ FEV1 < 80% predicted
Gold 3 30% ≤ FEV1 < 50% predicted
Gold 4 < 30% FEV1 predictedGlobal Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
What’s your Letter Grade?
• Based on the patient characteristics, how would you classify this patient?– A. Category A– B. Category B– C. Category C– D. Category D
Revised Classification System
CC DD
AA BB
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
mMRC 0‐1 mMRC ≥ 2
CAT < 10 CAT ≥ 10
Symptoms
Exacerbation History
≥ 2 or ≥ 1 leading to hospital admission
0‐1 (Not leading to Hospital Admission)
Grade 3, Group A
GOLD Levels of EvidenceEvidence Category Sources of Evidence
A Randomized controlled trials (RCT); Rich body of evidence
B Randomized controlled trials (RCT) with important limitations to the body of evidence
C Nonrandomized trials; Observational studies
D Panel consensus judgment
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
Non‐Pharmacologic Treatment
Smoking Cessation
• Pharmacotherapy and Nicotine Replacement Therapies help to increase long‐term smoking abstinence rates
• E‐cigarette use is controversial
Vaccinations
• Annual Influenza vaccination (Evidence B)• 23‐valent pneumococcal polysaccharide vaccine (PPSV23): Decreased incidence of CAP in COPD patients < 65 YO w/ an FEV1< 40% (Evidence B)
• Adults ≥ 65YO, 13‐valent conjugated pneumococcal vaccine (PCV13) is effective in reducing bacteremia and serious pneumococcal disease (Evidence B)
Pulmonary Rehabilitation
• Pumonary rehabilitation improves dyspnea, health status, and exercise tolerance in stable patients (Evidence A)
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
Non‐Pharmacologic Treatment
Education/Self‐Management
• Education alone has not shown to be effective (Evidence C)• Self‐management interventions w/ communication w/ a health care professional improves health status and decreases hospitalizations and ER visits (Evidence B)
Palliative Care
• Opiates, neuromuscular electrical stimulation (NMES), oxygen, and fans blowing air onto the face can relieve breathlessness (Evidence C)
• In malnourished patients, nutritional supplementation may improve respiratory muscle strength and overall health status (Evidence B)
• Fatigue can be improved by self‐management education, pulmonary rehabilitation, nutritional support and mind‐body interventions (Evidence B)
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
MANAGEMENT OF STABLE COPD
Therapeutic Classes• Bronchodilators
– Short Acting Beta‐Agonist (SABA)– Long Acting Beta‐Agonist (LABA)– Short Acting Anticholinergics (muscarinics) (SAMA)– Long Acting Anticholinergics (muscarinics) (LAMA)– Combination products– Methylxanthines
• Corticosteroids– Inhaled – Oral– Combination Inhaled Corticosteroid + LABA
• Phosphodiasterase 4 Inhibitors• Antibiotics
Definitions: Types of Inhalers
MDI: Metered Dose Inhaler
‐ Chemical Propellant‐ Must coordinate
breath with inhalation‐ 8.9% lung depositions (mean dose delivered)
MDI: Metered Dose Inhaler
‐ Chemical Propellant‐ Must coordinate
breath with inhalation‐ 8.9% lung depositions (mean dose delivered)
DPI: Dry Powder Inhaler
‐ No chemical propellant‐ Requires a deep, fast breath‐ 28.5% lung deposition (mean dose delivered)
DPI: Dry Powder Inhaler
‐ No chemical propellant‐ Requires a deep, fast breath‐ 28.5% lung deposition (mean dose delivered)
SMI: Soft Mist Inhaler (Respimat®)‐ Slowly released‐ Long Lasting‐ Fine Droplets‐ 51.6% lung deposition (mean dose delivered)
SMI: Soft Mist Inhaler (Respimat®)‐ Slowly released‐ Long Lasting‐ Fine Droplets‐ 51.6% lung deposition (mean dose delivered)
Anderson P International Journal of COPD 2006; 1(3): 251‐259Pitcairn G et al. J Aerosol Med 2005; 18(3): 264‐272
Beta2‐Agonist BronchodilatorsDrug Inhaler (mcg) Nebulizer
solution(mg/ml)
Oral Vials for Injection (mg)
Duration of Action
Short Acting (SABA)
Levalbuterol(Xopenex®)
45‐90 MDI 0.1, 0.21, 0.25, 0.42
6‐8
Salbutamol (albuterol)(Proventil HFA®, Ventolin HFA®)
90, 100, 200 MDI &DPI
1, 2, 2.5, 5 2, 4, 5mg pill; 8mg XR,
0.024% syrup
0.1, 0.5 mg 4‐6, 12 (XR)
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
Beta2‐Agonist BronchodilatorsDrug Inhaler (mcg) Nebulizer solution
(mg/ml)Duration of Action
Long Acting (LABA)
Arformoterol(Brovana®)
0.0075 12
Formoterol(Performist®)
4.5‐9 DPI 0.01 12
Indacaterol(Arcapta Neohaler®)
75‐300 DPI 24
Olodaterol*(Striverdi Respimat®)
2.5, 5 SMI 24
Salmeterol(Serevent Diskus®)
25‐50 MDI &DPI 12
* Agents Marked in Red was released since the last GOLD update in 2011Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
Anticholinergic BronchodilatorsDrug Inhaler (mcg) Nebulizer solution
(mg/ml)Duration of Action
Short Acting (SAMA)
Ipratropium bromide(Atrovent®)
20‐40 MDI 0.2 6‐8
Long Acting (LAMA)
Aclidinium bromide*(Tudorza Pressair®)
400 DPI & MDI 0.0075 12
Glycopyrronium bromide*(Seebri Breezhaler®)
15.6 & 50 DPI 12‐24
Tiotropium(Spiriva Handihaler and Respimat®)
18 DPI, 2.5&5 SMI
24
Umeclidinium*(Incruse Ellipta®)
62.5 DPI 24
* Agents Marked in Red was released since the last GOLD update in 2011Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
New Bronchodilators in GOLDInhaler MOA Year Dose Product
Olodaterol (StriverdiRespimat®)
LABA 2014 2 inhalations once daily
Aclidiniumbromide(TudorzaPressair®)
LAMA 2012 1 inhalation BID
http://docs.boehringer‐ingelheim.com/Prescribing%20Information/PIs/Striverdi%20Respimat/striverdi.pdfhttps://www.tudorza.com/
New Bronchodilators in GOLDInhaler MOA Year Dose Product
Glycopyrronium bromide(SeebriBreezhaler®)
LAMA 2015 1 capsule inhaled BID
Umeclidinium (Incruse Ellipta®)
LAMA 2014 1 inhalation once daily
https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Incruse_Ellipta/pdf/INCRUSE‐ELLIPTA‐PI‐PIL.PDF
New Bronchodilators in GOLDInhaler MOA Year Dose Product
Tiotropium (Spiriva Respimat®)
LAMA 2014 2 inhalations once daily
https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Incruse_Ellipta/pdf/INCRUSE‐ELLIPTA‐PI‐PIL.PDF
GOLD: Bronchodilators in COPD• 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 FEV1and symptoms (Evidence A)
• LABAs and LAMAs significantly improve lung function, dyspnea, health status and reduce exacerbation rates (Evidence A)
• LAMAs have a greater effect on exacerbation reduction compared with LABAs (Evidence A) and decrease hospitalizations (Evidence B)
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
GOLD: Bronchodilators in COPD• Tiotropium improves the effectiveness of pulmonary rehabilitation in increasing exercise performance (Evidence B)
• LABAs and LAMAs are preferred over SA agents except for patients with only occasional dyspnea (Evidence A)
• Patients may be started on single LABA or LAMA or LABA+LAMA. In patients with persistent dyspnea on one bronchodilator treatment, treatment should then be escalated to dual therapy (Evidence A)
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
Combination ProductsDrug Inhaler (mcg) Nebulizer solution
(mg/ml)Duration of Action
Short Acting Beta2 Agonist + Anticholinergic
Salbutamol/ipratropium(Combivent Respimat®, Duoneb®)
100/20 SMI, 75/15 MDI 0.5, 2.5mg in 3ml 6‐8
Long Acting Beta2‐Agonist + Anticholinergic
Formoterol/glycopyrronium *(Bevespi Aerosphere®)
9.6/14.4 DPI 12
Indacaterol/glycopyrronium*(Utibron Neohaler®)
27.5/15.6 & 110/50 DPI
12‐24
Vilanterol/umeclidinium*(Anoro Ellipta®)
25/62.5 DPI 24
Olodaterol/tiotropium*(Stiolta Respimat®)
5/5 SMI 24
* Agents Marked in Red was released since the last GOLD update in 2011Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
GOLD: Combination Bronchodilators
• Combination treatment with a LABA and LAMA increases FEV1 and reduces symptoms compared to monotherapy (Evidence A)
• Combination treatment with a LABA and LAMA reduces exacerbations compared to monotherapy (Evidence B) or ICS/LABA (Evidence B)
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
LABA/LAMA vs. MonotherapyTrial Farne HA, Cates CJ. Long‐acting beta2‐agonist in addition to
tiotropium vs. either tiotropium or long‐acting beta2‐agonist alone for COPD
Methods Cochrane Database Review10 studies10.894 patients
Intervention Tiotropium +LABA vs. Tiotropium vs. LABA
Results ‐ Small improvement in HR‐QOL and FEV1 with combination therapy
‐ Adding Tiotropium to a LABA decreased exacerbations, but not vice versa
‐ No effect on hospitalizations
Cochrane Database Syst Rev 2015; 10(10):CD008989.
LAMA/LABA Combinations in GOLDInhaler MOA Year Dose Product
Formoterol/glycopyrronium(BevespiAerosphere®)
LAMA/LABA 2016 2 inhalations BID
Indacaterol/glycopyrronium(UtibronNeohaler®)
LAMA/LABA 2015 1 capsule inhaled once BID
https://www.pharma.us.novartis.com/utibron‐neohaler
LAMA/LABA Combinations in GOLDInhaler MOA Year Dose Product
Vilanterol/umeclidinium(Anoro Ellipta®)
LAMA/LABA 2013 1 inhalation once daily
Olodaterol/tiotropium(StioltaRespimat®)
LAMA/LABA 2015 2 inhalations once daily
http://www.anoro.com/about/index.html?bing=e_&rotation=71700000009621674&banner=58700000826471212&kw=8776596690&cc=099FF0995E7A&pid=43700008776596690
https://www.stiolto.com/what‐is‐stiolto‐respimat?sc=STOACQBRABANBING160602&utm_source=bing&utm_medium=cpc&utm_term=Stiolto_respimat&utm_campaign=Branded_‐_Stiolto_Respimat_[Exact]&gclid=CIn4752rgtMCFYqiNwod6‐sCCA&gclsrc=ds
Combination ProductsDrug Inhaler (mcg) Duration of Action
Long Acting Beta2‐Agonist + Corticosteroids
Formoterol/budesonide(Symbicort®)
4.5/160 MDI, 4/5/80 MDI, 9/320 DPI, 9/160 DPI
12
Formoterol/mometasone(Dulera®)
10/200, 10/400 MDI 12‐24
Salmeterol/fluticasonse(Advair HFA®, Advair Diskus®)
5/100, 5/250, 5/500 DPI; 21/45, 21/115, 21/230 MDI
24
Vilanterol/fluticaone furoate*(Breo Ellipta®)
25/100 DPI 24
* Agents Marked in Red was released since the last GOLD update in 2011
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
ICS/LABA Combinations in GOLDInhaler MOA Year Dose Product
Vilanterol/fluticaone furoate(Breo Ellipta®)
ICS/LABA 2013 1 inhalation twice daily
http://www.mybreo.com/?bing=e_&rotation=71700000020120045&banner=58700002134115964&kw=17657748589&cc=9A7DDB62954F&pid=43700008776747173&gclid=CPD1i_GtgtMCFYGONwodHRYPDw&gclsrc=ds
Fluticasone Furoate‐VilanterolTrial Vestbo J, Leather D, Diar Bakerly N, et al. Effectiveness of
Fluticasone Furoate and vilanterol for COPD in Clinical Practice
Methods Prospective, 12 month, open‐label, parallel randomized multi‐center trial
Intervention Fluticasone furoate‐Vilanterol (100/25 mcg) inhaled once daily vs. Usual Care* Allowed to continue LAMA use
Primary Outcome Rates of moderate‐severe exacerbations in those who had at least 1 exacerbation in the last year
BaselineCharacteristics
N Engl J Med 2016; 575(13):1253‐60.
Fluticasone Furoate‐Vilanterol
N Engl J Med 2016; 575(13):1253‐60.
Fluticasone Furoate‐Vilanterol
N Engl J Med 2016; 575(13):1253‐60.
GOLD: ICS and LABAs in COPD• ICS + LABA is more effective than the individual components in improving lung function and health status and reducing exacerbations in patients with exacerbations and with moderate to severe disease(Evidence A)
• Regular treatment with ICS increases the risk of pneumonia, especially those with severe disease (Evidence A)
• Triple inhaled therapy ICS/LAMA/LABA improves lung function, symptoms and health status (Evidence A) and reduces exacerbations (Evidence B) compared to ICS/LABA or LAMA monotherapy
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
Triple TherapyYear Trial # Interventions Results
2008 Sigh D, Brooks J, Haga G, et al.
41 ‐Salmeterol/fluticasonepropionate (50/500) BID + tiotropium (18 mcg) once daily‐ Individual Components
‐ Triple therapy led to great improvement in spirometry data vs. the individual components
2012 Jung KS, Park HY, Park SY, et al.
657 ‐Salmeterol/fluticasonepropionate (50/250) BID+ tiotropium once daily(18 mcg) ‐ Tiotropium (18 mcg) once daily
‐ Triple therapy provided greater spirometry changes andimproved QOL score vs. monotherapy
2015 Frith PA, Thompson PJ, Ratnavadivel R, et al.
773 ‐ Salmeterol/fluticasonepropionate (50/500) BID + EITHERTiotropium 18 mcg daily, Glycopyrronium 50 mcg daily, or Placebo
‐ Triple therapy including Glycopyrronium was found to be non‐inferior to that with Tiotropium
ICS and Risk of Pneumonia
• Highest Risk– Current smokers– BMI< 25 kg/m2
– Age ≥ 55 years old– History of prior exacerbations or pneumonia– Poor MRC dyspnea grade – Severe airflow limitations
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.orgAnnals of the American Thoracic Society 2015; 12(1)27‐34
GOLD: Corticosteroids and PDE 4 inhibitors in COPD
• Long term use of oral glucocorticoids has numerous side effects(Evidence A) with no evidence of benefit (Evidence C)
• In patients with chronic bronchitis, severe to very severe COPD and a history of exacerbations, A PDE‐4 inhibitor improves lung function and reduces moderate to severe exacerbations (Evidence A) and also dose this in patient who are on fixed doses LABA/ICS combinations (Evidence B)
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
Other AgentsDrug Oral Vials for Injection (mg) Duration of Action
Methylxanthines
Aminophylline 105 mg/ml 250, 500 mg Variable, up to 24 hours
Theophylline SR 100‐600mg pill 250, 400, 500 mg Variable, up to 24 hours
Phophodiesterase‐4 Inhibitors
Roflumilast 500 mcg pill
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
Antibiotics Use in COPD
• Regimens:– Azithromycin: 250mg PO daily or 500mg TIW– Erythromycin 500mg PO BID
• Mainly reserved for individuals with severe disease and frequent exacerbations
• Has been shown to increase the incidence of bacterial resistance and impaired hearing test
• No data beyond 1 year of useGlobal Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.orgAm J Respir Crit Care Med 2008; 178(11):1139‐47.The Lancet Respiratory medicine 2014;2(5):361‐8.N Engl J Med 2011; 365(8):689‐98.
Role of Antibiotics: Meta‐AnalysisTrial Ni W, Shao X, Cai X, et al. Prophylactic Use of macrolide
antibiotics for prevention of COPD exacerbations: A Meta‐Analysis
Methods 9 studies1,666 patients
Interventions Azithromycin, Erythromycin and Clarithromycin at varying doses and frequencies
PlOS one 2015; 10(3):e0121257
Role of Antibiotics: Meta‐Analysis
PlOS one 2015; 10(3):e0121257
GOLD: Other Medication Therapies• Antibiotics
– Long term azithromycin and erythromycin therapy reduces exacerbations over one year (Evidence A)
– Treatment with azithromycin is associated with an increased incidence of bacterial resistance (Evidence A) and hearing test impairment (Evidence B)
• Statins– Statin therapy is not recommended for prevention of exacerbations (Evidence A)
• Theophylline– Theophylline is not recommended unless other long‐term bronchodilators are unavailable or unaffordable (Evidence B)
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
GOLD: Oxygen Therapy in COPD
• Long‐term administration of oxygen increases survival in patients with severe chronic resting arterial hypoxemia (Evidence A)
• In those with stable COPD and with exercised induced desaturations, long term oxygen does not lengthen time to death or first hospitalization or provide sustained benefits long term (Evidence A)
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
Treatment Algorithm
Group C‐ Start with a LAMA
‐ If sx persist, switch to EITHER LAMA+LABA OR
LABA+ICS
Group C‐ Start with a LAMA
‐ If sx persist, switch to EITHER LAMA+LABA OR
LABA+ICS
Group D‐ LABA + LAMA
‐ If sx persist, switch to ICS/LABA
‐ If sx persist, consider ICS/LABA + LAMA
Group D‐ LABA + LAMA
‐ If sx persist, switch to ICS/LABA
‐ If sx persist, consider ICS/LABA + LAMA
Group A‐ Bronchodilator
(SABA, SAMA, LABA, or LAMA)
‐ If sx persistent switch to another alternative
class
Group A‐ Bronchodilator
(SABA, SAMA, LABA, or LAMA)
‐ If sx persistent switch to another alternative
class
Group B‐ LABA or LAMA
‐ If sx persists, change to LABA + LAMA
Group B‐ LABA or LAMA
‐ If sx persists, change to LABA + LAMA
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
If FEV1< 50% and has chronic bronchitis consider starting roflumilast
Consider macrolide (in former smokers
Patient Case
• Pt. with an FEV1< 45%• Pt. only has trouble with SOB when walking quickly or uphill
• She has had 1 COPD exacerbation in the last year that was treated as an outpatient
Grade Post‐Bronchodilator FEV1
Gold 1 FEV1≥ 80% predicted
Gold 2 50% ≤ FEV1 < 80% predicted
Gold 3 30% ≤ FEV1 < 50% predicted
Gold 4 < 30% FEV1 predictedGlobal Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
Patient Case
CC DD
AA BB
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
mMRC 0‐1 mMRC ≥ 2
CAT < 10 CAT ≥ 10
Symptoms
Exacerbation History
≥ 2 or ≥ 1 leading to hospital admission
0‐1 (Not leading to Hospital Admission)
Grade 3, Group A
Patient Case
• Based on the following classification, which of the following therapies would be the BEST initial therapy to begin in this patient?– A. ICS alone– B. LABA alone– C. LAMA alone– D. ICS/LABA
Monitoring
• Measurements (at least yearly)– Spirometry– 6‐minute walking distance– Measure oxygenation at rest
• Symptoms– Cough, sputum production, breathlessness, fatigue, activity limitation and sleep disturbances
• Exacerbations• Imaging• Smoking status
Global Initiative For Chronic Obstructive Lung Disease 2017 Reportwww.goldcopd.org
Monitoring
• Pharmacotherapy– Assess inhaler technique– Review dosages – Assess adherence– Side effects
Thorax 2009; 64:939‐43.
Cost Considerations
Patient Case
• The patient returns in 8 months following 2 exacerbations, 1 which resulted in a hospitalization. She states that she has had increased cough and sputum production. Which would be the next BEST therapy option?– A. Change to an ICS/LABA therapy– B. Change to a LABA/LAMA therapy– C. Initiate Azithromycin 250mg PO daily– D. Change to ICS/LABA + LAMA
Questions