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The GOLDen Rule: An Update on Chronic Obstructive
Pulmonary Disease (COPD) Guidelines
Rory Johnson, Pharm.D., AE-C
University of Montana
rory.johnson@mso.umt.edu
Disclosures
• Nothing to disclose
Objectives
• At the conclusion of this presentation, participants should be able to:
• Recommend appropriate pharmacologic treatment for COPD patients based on the refined ABCD assessment tool.
• Utilize tools that can improve inhaled medication administration and delivery for patients with COPD.
Definition & Overview
• Common & preventable disease of persistent airflow limitation caused by:
• Mixture of small airways disease (obstructive bronchiolitis)
• Parenchynmal destruction (emphysema)
• Symptoms include dyspnea, cough and/or sputum production
• Main risk factor is smoking
• Other factors: environmental exposures, host factors (genetics, age, asthma, etc.)
Pathophysiology
• Inflammation in respiratory tract to chronic irritants
• Airway edema
• Excess mucus production
• Impaired ciliary motility
• Thickening of smooth muscle and connective tissue in the airways
• Chronic inflammation results in repeated injury and repair process that lead to scarring and fibrosis
COPD Burden
• Leading cause of morbidity & mortality worldwide
• US: projected to be 3rd leading cause of death by 2020
• Significant economic burden
• US: >$50 billion annually in direct & indirect costs
• Social Impact
• US: second leading cause of reduced DALYs (Disability-Adjusted Life Year)
Diagnosis
• Diagnosis may be considered if patient exhibits the following:
• Symptoms: progressive dyspnea, chronic cough, sputum production
• History of exposure to risk factors including intensity and duration
• Family history of COPD
• **SPIROMETRY IS REQUIRED FOR DIAGNOSIS**
• FEV1/FVC of < 0.70 (postbronchodilator) indicates persistent & irreversible airflow limitation
Spirometry
FEV1 – forced
expiratory volume
in 1 second
FVC – Functional
Vital Capacity
(lung volume)
“Normal”spirometry values
predicted by age
and height.
Initial Assessment
• To determine the degree & severity of COPD, the following aspects should be assessed separately:
• Spirometric abnormality
• Nature of patient’s symptoms
• Exacerbation history & future risk
• Comorbidities
Symptoms
• Validated tools to measure symptoms
• Modified British Medical Research Council Questionnaire (mMRC)
• COPD Assessment Test (CAT™) - preferred
• COPD impacts patients beyond dyspnea, so best to use a comprehensive assessment of symptoms including:
• Cough, phlegm, sleep, energy, activities, etc.
Exacerbation History & Risk
• Exacerbation – acute worsening of symptoms resulting in additional therapy
• Mild – treated w/ short acting bronchodilator (SABDs) only
• Moderate – SABDs + antibiotic &/or oral corticosteroid
• Severe – hospitalization or ED visit (possible respiratory failure)
• Best predictor – history of earlier treated event
• Other predictors – deteriorating airflow & blood eosinophil count
Comorbidities
• Common comorbid conditions may affect mortality & hospitalization risk:
• Cardiovascular disease
• Osteoporosis
• Depression/anxiety
• Skeletal muscle dysfunction
• Lung cancer
Practice Case #1
• Use the revised combined COPD assessment tool to classify a 56 year old female’s COPD based on the following information: FEV1 = 55% w/ CAT score <10 and 1 hospitalization 3 months ago for COPD exacerbation.
• GOLD grade 2, group A
• GOLD grade 3, group A
• GOLD grade 2, group C
• GOLD grade 3, group C
Prevention & Maintenance Therapy
• SMOKING CESSATION: most effective intervention to reduce the risk of developing COPD and slow its progression
• Smoking cessation counseling should be done at every visit
• Pharmacotherapy & NRT are effective at increasing abstinence rates
• Five A’s to help patient quit smoking
• Ask, Advise, Assess, Assist, Arrange
Adapted from Fletcher CM, Peto R (1977). The natural history of chronic airflow obstruction. BMJ, 1(6077): 1645–1648.
Artist: Bryan Matthew Boutwell http://www.livefiction.net/content/intervention_inhaler
The Intervention of an Inhaler
Pharmacologic Therapy
• Treatment goals:
• Control & prevent symptoms – can’t modify progression or prolong survival
• Prevent & treat exacerbations – reduce frequency & severity
• Enhance patient quality of life – improve health status & exercise tolerance
Pharmacotherapy Options
Beta2-agonists
Short-acting beta2-agonists (SABA)
Long-acting beta2-agonists (LABA)
Anticholinergics
Short-acting anticholinergics (SAMA)
Long-acting anticholinergics (LAMA)
Combination short-acting beta2-agonists + anticholinergic
Methylxanthines
Inhaled corticosteroids
Combination long-acting beta2-agonists + corticosteroid
Systemic corticosteroids
Phosphodiesterase-4 inhibitors
Short Acting Bronchodilators
• Short-acting B2 agonist (SABA)
• Albuterol 2 puffs q 4 hours
• Short acting anticholinergics
• Ipratropium 2 puffs q 4 hours
• Combination SABA/short-acting anticholinergic
• Albuterol/ipratropium (Combivent®)
• Different mechanisms: improves efficacy
• Reduce potential adverse effects from increasing dose of individual agents
Long Acting Bronchodilators
• Long-acting B2-agonists (LABA)
• Salmeterol DPI: 1 inhalation BID
• Formoterol DPI: 1 inhalation BID
• Arformoterol 15-30 mcg nebulized BID
• Indacterol
• Long-acting anticholinergics (LAMA)
• Tiotropium DPI (Spiriva): 1 inhalation once daily
• Aclidinium (Tudorza): 1 inhalation BID
Methylxanthines
• Theophylline & aminophylline
• Generally not recommended unless other options are not available or not affordable for long-term treatment
• Lower efficacy, increased side effects with theophylline
• Narrow therapeutic index, drug-drug interactions
• Typically reserved as add-on therapy in patients with more severe COPD
Inhaled Corticosteroids
• Unlike ICS use in asthma, regular use does not modify the disease progression or improve FEV1; no decrease in overall mortality
• May increase likelihood of pneumonia
• Combination therapy with LABA is more effective than individual components in decreasing exacerbations; long-term monotherapy is not recommended
• Long-term treatment with ICS is recommended in addition to long-acting bronchodilators for patients with severe to very severe (GOLD 3-4) airflow limitation and frequent exacerbations not controlled by bronchodilators alone
Combination ICS/LABA
• Advair (fluticasone/salmeterol)
• Diskus DPI & HFA
• Symbicort HFA(budesonide/formoterol)
• Dulera HFA (mometasone/formoterol)
• Breo Ellipta DPI (fluticasone/vilanterol)
PDE-4 Inhibitor - Roflumilast
• Selectively inhibits phosphodiesterase-4, increasing accumulation of intracellular cAMP, which is thought to decrease inflammatory activity
• NOT a bronchodilator
• May be added to reduce exacerbations for patients with FEV1 < 50% of predicted, chronic bronchitis, and frequent exacerbations
• Statistically significant reduction in exacerbations in patients with severe COPD associated with chronic bronchitis, with ≥1 exacerbation in the previous year and ≥20 pack-year smoking history
Expectorants & Mucolytics
• No proven benefit in literature
• Guidelines do not suggest that any of the expectorants are more effective than proper hydration
• Still a place in therapy?
Managing Exacerbations
• Most commonly caused by viral URTI
• Diagnosis relies on clinical presentation of patient w/ acute decline that is outside day-to-day variation
• Symptoms of exacerbation:
• Increased wheezing, chest tightness, cough, and sputum production, change in sputum tenaciousness, fever
• Goals:
• Prevention of hospitalization or reduction in hospital stay
• Prevention of acute respiratory failure and death
• Resolution of exacerbation symptoms and a return to clinical status and quality of life
• Prevent development of subsequent exacerbations
Exacerbations: Treatment Options
• Oxygen
• Titrate to target saturation of 88-92%
• Bronchodilators
• SABA ± SAMA usually preferred for treatment of exacerbation
• SABA: Increase dose and/or frequency
• Consider adding ipratropium until symptoms improve
• Systemic Corticosteroids
• Can improve FEV1, oxygenation and shorten recovery time and hospital duration
• Duration of therapy should be 5-7 days
Antibiotics
• Antibiotics should be initiated when 2 of the 3 symptoms are present
• Increased dyspnea, increased sputum volume, increased sputum purulence
• Empirical therapy should be based on most likely organism thought to be responsible for infection
• H. influenzae: 2nd or 3rd generation cephalsporin
• M. catarrhalis: Doxycycline
• S. pneumoniae: Macrolide
• Therapy should be continued for 5-7 days
Azithromycin to Prevent COPD Exacerbations
• 1577 subjects given azithromycin 250mg once daily or placebo, followed for 1 year
• Reduced median time to exacerbation (266 days in azithromycin treatment vs. 174 in placebo group, p<0.001)
• Macrolides may:
• Play anti-inflammatory role in addition to antibacterial effects
• Decrease sputum/mucus production & modify neutrophil response
• Problems with resistance?
http://www.nejm.org/doi/full/10.1056/NEJMoa1104623#t=abstract
Patient Case #2
• Use the revised combined COPD assessment tool to classify a 67 year old male’s COPD based on the following information: FEV1 = 45% w/ CAT score of 9 and 2 hospitalizations for COPD exacerbations in the previous year.
• His last pneumococcal vaccination was when he was 58. He currently uses Combivent Respimat twice daily and doesn’t think it works very well. He also uses Spiriva 3-4 times per week. What action steps would you consider?
Optimum Inspiratory Flow
• Delivery to lungs is dependent on inspiratory airflow and medication
device resistance
• Inspiratory flow requirements may vary between devices
Vaccinations
• Influenza vaccine decreases serious illness and death by 50%
• Pneumococcal polysaccharide (PPSV23) vaccine is recommended for all COPD patients
• Recently the Advisory Committee on Immunization Practices(ACIP) updated recommendations on Pneumococcal Polysaccharide Vaccine (PPSV23) to include a single vaccination for patients <65 with asthma and smokers ages 19-64
References
• Global Initiative for Chronic Obstructive Lung Disease (GOLD). GOLD 2017 global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease, 2017 report. November 17, 2016. http://goldcopd.org/gold-2017-global-strategy-diagnosis-management-preve.... Accessed November 28, 2017.
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