COPD Patient Intervention Module

8/11/2019 COPD Patient Intervention Module

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COPD: Patient Intervention

Peter J. Carek, MD, MSProgram Director, Trident/MUSC Family Medicine Residency,Charleston, SC

Lori M. Dickerson, PharmDAssociateProgram Director, Trident/MUSC Family Medicine Residency,Charleston, SC


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Educational Objectives

At the end of this presentation, the learner should

be able to

Discuss the pharmacologic treatment of chronic

obstructive pulmonary disease (COPD) Manage acute exacerbations

Evaluate components and effectiveness ofCOPD disease management programs and

group visits Provide instruction in use of patient diaries


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Oxygen therapy

Pulmonary rehabSupplementalTherapy

Stepwise

Drug Therapy

Health Care Maintenance

Combination of inhaled corticosteroid, long-acting-agonist, and long-acting anticholinergic

Combination of anticholinergicand -agonist bronchodilator

Short-actinginhaledbronchodilator

for acute reliefof symptoms

Pneumococcal and annual influenza vaccination, smoking cessationand regular assessment of lung function

Adapted from Sutherland, 2004


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Pharmacologic Therapy

Oxygen therapy Used as long-term continuous therapy, during exercise,

or to relieve acute dyspnea

Improves survival in COPD patients with severehypoxemia (partial pressure of oxygen [pO2] < 55 mm Hgor oxygen saturation [sO2] 15 hours daily Does not improve survival in patients with moderate

hypoxemia or desaturation at night Cranston, 2008GOLD, 2009


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Oxygen therapy Candidates include patients with very severe COPD who

have walking pO2

55 mm Hg or oxygen saturation less than 88%, with or withouthypercapnia (SOR: B)

between 55 and 60 mm Hg with pulmonary hypertension,peripheral edema suggesting heart failure, or polycythemia(hematocrit > 55%) (SOR: C)

Cranston, 2008

GOLD, 2009


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Oxygen therapy Titrate to pO2of at least 60 mm Hg or oxygen saturation

of at least 90%.

Beware of pushing O2saturation too high - can turn offthe respiratory drive in CO2retainers

Cranston, 2008

GOLD, 2009


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Bronchodilators Foundation of symptomatic treatment

Improve airflow and hyperinflation, decrease work of breathingand improve exercise tolerance

Do not slow the progression of COPD (SOR: B)

Types Beta2-agonists (long-acting, short-acting)

Anticholinergics (long-acting, short-acting)

Combinations

GOLD, 2009


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Pharmacologic TherapyBeta agonists - Mechanism of action

Stimulate 2-adrenergic receptors, increasing cyclic AMP and

relaxing airway smooth muscle

Short-acting

agent Inhaler (mcg/puff) Cost Solution Cost

Albuterol MDI (90) $ 0.63, 1.25 mg/3 mL; 2.5mg/0.5 mL; 2.5 mg/3 mL $$

Levalbuterol MDI (45) $ 0.31, 0.63, 1.25 mg/3 mL $$$$$

Salmeterol DPI (50) $$$ NA

Formoterol DPI (12) $$$ 20 mcg/2 mL $$$$$

Aformoterol NA 15 mcg/2 mL $$$$$

MDI = metered dose inhaler; DPI = dry powder inhaler; NA = not available.

Rabe, 2007; GOLD, 2009


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Pharmacologic TherapyAnticholinergics - Mechanism of action

Block effect of acetylcholine on muscarinic-type 3 receptors,resulting in bronchodilation.

Agent Inhaler (mcg/puff) Cost Solution Cost

Short-acting

Ipratropium MDI (17) $ 0.5 mg/2.5 mL $$Long-acting

Tiotropium DPI (18) $$$ NA

Combinations

Albuterol +

Ipratropium

MDI (90 + 18) $$$ 2.5 + 0.5 mg/3 mL $$$$

MDI = metered dose inhaler; DPI = dry powder inhaler; NA = not available.

Rabe, 2007; GOLD, 2009


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Short-acting bronchodilators Used as needed for all stages of COPD (SOR: A)

Albuterol or Ipratropium

Longer duration of action with ipratropium (6-8 hours) thanalbuterol (4-6 hours) (SOR: A)

Ipratropium not used alone for rescue, but is used formaintenance.

Combination slightly better bronchodilation thaneither agent alone (SOR: A)

Rabe, 2007

GOLD, 2009


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Long-Acting 2 Agonists (LABAs) No evidence of tolerance with regular use (SOR: A)

No known difference among agents (salmeterol,

formoterol, aformoterol) Can use short-acting anticholinergic or beta2-agonist

for relief of symptoms

Rabe, 2007

GOLD, 2009


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Long-acting anticholinergics

Short-acting beta2-agonists (ie, albuterol) arerecommended for relief of symptoms (SOR: A)

Should not use short-acting anticholinergics (ie,ipratropium) for relief of symptoms if also usinglong-acting anticholinergic

Kerstjens, 2007GOLD, 2009


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Anticholinergics and cardiovascular events

In meta-analyses, anticholinergic agents havebeen associated with cardiovascular events

Ipratropium > tiotropium (SOR: B)

Significant limitations to study

Large, prospective randomized controlled trial of

tiotropium found no association withcardiovascular events Singh, 2008Celli, 2010

Ogale, 2010


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Inhaled bronchodilators - Summary Stick with the GOLD guidelines

Use short-acting bronchodilators as needed forsymptoms (SOR: A)

When regular use is needed, long-actingbronchodilators are more effective and convenient(SOR: A)

Consider the patients baseline cardiovascularrisk before prescribing an anticholinergic(SOR: C)

Encourage smoking cessation


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Theophylline Oral bronchodilator

May be used if: Symptoms continue despite combined inhaled bronchodilators (SOR: B)

Cost of inhalers prohibits their use Rarely done because:

Toxicity (elderly, liver disease, heart failure)

Frequent monitoring to maintain levels within narrow therapeutic range(5-12 mcg/mL)

Adverse reactions

Drug interactions (metabolized via CYP 1A2, CYP 3A4)

Use slow-release products (available in generic)Rabe, 2007

GOLD, 2009


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Corticosteroids Effects much less dramatic in patients with COPD vs.

patients with asthma Pulmonary inflammation not prominent in COPD

Unknown if effects vary by patient or stage of disease

No longer recommend short course (2 weeks) of oralsteroids to identify COPD patients who might benefitfrom inhaled steroids (SOR: A) Poor predictor of long-term response to inhaled steroids in

COPD

Rabe, 2007

GOLD, 2009


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Corticosteroids Long-term oral steroids not recommended for patients

with stable COPD (SOR: A)

Add inhaled steroids to inhaled bronchodilator(s) in

patients with severe COPD and frequent exacerbations(SOR: A) Statistically significant impact on following indicators

Frequency of exacerbations

Quality of life

Hospitalization rates

Does not slow progression of COPDRabe, 2007

GOLD, 2009


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Inhaled corticosteroids (ICS) ICS must be used in combination with LABA for

patients with COPD

ICS monotherapy only FDA approved for treatment of

asthma, not COPD

Agent Inhaler (mcg/puff) Cost

Fluticasone/salmeterol DPI (100/250/500 + 50) $$$$

Budesonide/formoterol MDI (80/160 + 4.5) $$$$

Mometasone/formoterol MDI (100/200 + 5) $$$$

DPI = dry powder inhaler; MDI = metered dose inhaler.


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ICS - Benefits and harms In severe COPD, twice daily combination therapy with ICS

(fluticasone 500 mcg daily) plus LABA (salmeterol 50 mcg daily) vs.placebo resulted in:

No effect on quality of life, total mortality or COPD related-deaths Reduced frequency of moderate to severe exacerbations, exacerbations

requiring steroids or hospitalization

Effect size very small (0.030.34 exacerbations per year difference)

Increased risk of pneumonia (number needed to harm [NNH] = 14)

ICS alone increased mortality (NNH = 30) and COPD-related deaths(NNH = 46) compared with combination therapy

Calverley, 2007


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ICS - Benefits Meta-analysis confirmed the small impact of ICS on

frequency of exacerbations

FEV1 < 50% predicted (severe disease) Relative risk of exacerbations 0.79 (95% CI, 0.690.89)

Over 5-year period, patients with severe disease having 2exacerbations per year would have 8 instead of 10exacerbations if they used ICS

FEV1 > 50% predicted (less severe disease) No significant change in exacerbation risk. Relative risk of

exacerbations 1.03 (95% CI, 0.861.23)Agarwal, 2010


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ICS - Adverse effects

Pneumonia

Increased risk with ICS alone and combination ICS +

LABA (NNH = 14-16) Confirmed in large meta-analysis of COPD patients

receiving ICS for at least 24 weeks Relative risk of any pneumonia 1.6 (95% CI, 1.331.92)

Relative risk of serious pneumonia 1.71 (95% CI, 1.461.99)

No increase in pneumonia-related mortality Calverley, 2007Singh, 2008


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Inhaled Corticosteroids (ICS) - Summary Monotherapy should be avoided (SOR: A)

Monotherapy with LABA appears to be safe

ICS (alone or in combination) may be harmful (SOR: A) Increased risk of pneumonia

Combination therapy (LABA + ICS) offers littleadvantage in terms of exacerbations (SOR: A) Reserve for patients with severe COPD (FEV1 < 50% predicted)

(SOR: A)


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LABA/ICS vs. Tiotropium No difference in frequency of exacerbations or quality of

life when patients with severe COPD given

salmeterol/fluticasone 50/500 mcg twice daily ortiotropium 18 mcg daily Salmeterol/fluticasone associated with exacerbations requiring

antibiotics

Tiotropium associated with exacerbations requiring oral steroids

Wedzicha, 2008


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LABA/ICS plus tiotropium Cohort study of Veterans Affairs patients with COPD

found:

LABA/ICS + tiotropium (compared with LABA/ICS alone)associated with:

Reduced risk of death (0.60 ; 95% CI, 0.45 - 0.79)

Reduced risk of rates of COPD exacerbations (0.84; 95% CI, 0.73 -0.97)

Fewer COPD hospitalizations (0.78; 95% CI, 0.62 - 0.98)

Not a prospective randomized controlled trial

Limitations, biasLee, 2009


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Which of the following pharmacologic

treatments has been shown to improvemortality in patients with COPD?

A. Short-acting inhaled beta2-agonistsB. Inhaled corticosteroids

C. Oxygen

D. Long-acting inhaled anticholinergics


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Which of the following pharmacologic

treatments has been shown to increaseFEV1long term in patients with COPD?

A. Short-acting inhaled beta2-agonistsB. Inhaled corticosteroids

C. Long-acting inhaled anticholinergics

D. None of the above


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Beta blockers in COPD Medical mythBeta blockers are contraindicated in

COPD

No significant adverse respiratory effects with cardio-selective beta blockers in patients with mild-moderatereversible airway disease or COPD Atenolol, bisoprolol, metoprolol

Use of beta blockers decreased mortality andexacerbations in patients with COPD Even in absence of overt cardiovascular disease Salpeter, 2005

Rutten, 2010


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Acute exacerbations Bronchodilator therapy

Improve airflow (i.e. FEV1) and symptoms during acuteexacerbations (SOR: A)

Use short-acting beta2-agonist (albuterol) or combination beta2-agonist and anticholinergic

Metered dose inhaler (MDI) + spacer as effective as nebulizeddelivery (SOR: C)

Training on MDI technique essential

Coordination in elderly patients may hinder use Nebulized delivery provides subjective benefit without difference inFEV1 in acute exacerbations (SOR: B)

GOLD, 2009

Evensen, 2010


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Systemic corticosteroids

Shorten recovery time, improve FEV1 andhypoxemia (SOR: A)

May reduce risk of early relapse, treatmentfailure, and length of hospitalization

Rabe, 2007GOLD, 2009


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Systemic corticosteroids Oral administration

In non-critically ill patients, no difference in treatment failure with high-dose intravenous steroids (ie, methylprednisolone) vs. low-dose oral

prednisone Oral prednisone (30 - 40 mg for 7 to 10 days) (SOR: C)

Oral corticosteroids highly bioavailable, inexpensive, easy to use

Preferred for patients with functioning intestinal tract able to take oralmedications

Intravenous administration Reserved for critically ill patients

No role for inhaled corticosteroids in acute exacerbations deJong, 2007Lindenauer, 2010


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Corticosteroids - Tapering

Consider tapering if:

Treating disease flare in patient taking systemic

steroids prior to flare Course lasts more than 2-3 weeks

Consider not tapering if:

Course lasts less than 2-3 weeks

Patient not taking systemic steroids prior to flare


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Corticosteroids - Tapering

Tapering is more an art than science

One idea

40 mg daily for 14 days then stop

If you want to taper (fear of disease rebound, takingsteroids before event), try 60 mg daily for 14 days,then 40 mg daily for 7 days, then 20 mg daily for 7

days, then 10 mg every other day for 7 days, thenstop.


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Antibiotics

Beneficial for patients presenting with an increase in anyof the following three symptoms (SOR: B) Dyspnea

Sputum volume

Sputum purulence

Beneficial for patients with severe exacerbationsrequiring mechanical ventilation (SOR: B)

Treatment should be given for 3-7 days (SOR: C)

Rabe, 2007

GOLD, 2009


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Pharmacologic TherapyAntibiotic Regimens

Definition Oral Treatment IV Treatment

Mild exacerbation: no riskfactors for poor outcome

Amoxicillin, doxycycline,TMP/SMX, azithromycin,3rd generationcephalosporin

Moderate exacerbation withrisk factor(s)* for pooroutcome

Amoxicillin-clavulanate,levofloxacin, moxifloxacin

Ampicillin-sulbactam, 3rdgeneration cephalosporin,levofloxacin, moxifloxacin

Severe exacerbation withrisk factors forPseudomonas aeruginosa

Ciprofloxacin, levofloxacin(high dose)

Ciprofloxacin, levofloxacin(high dose), beta lactamwith P. aeruginosaactivity

*comorbid diseases, severe COPD, frequent exacerbations (> 3/year), antimicrobial use within

past 3 months.

GOLD, 2009


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Preventive therapy opportunities

Vaccination

Influenza

Annually for all patients with COPD (SOR: A)

Pneumococcal All patients < 65 years with COPD

Anyone >65 years old

All smokers

Counseling for smoking cessationRabe, 2007

GOLD, 2009


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Nonpharmacologic Therapy

Disease management

Effectiveness of COPD management programs

Trials

9 randomized, 1 controlled, 3 uncontrolled before-after

Results Improve exercise capacity (32.2 min; 95% CI, 4.1 - 60.3)

Reduce risk of hospitalization

Moderately improve health-related quality of life All-cause mortality did not differ between groups (pooled

odds ratio 0.84; 95% CI, 0.54 - 1.40)

Peytremann-Bridevaux, 2008


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Disease management Improve use of spirometry

Ensure patients receive adequate vaccines

Educate patients and provide tools to manage theirCOPD

Refer patients to pulmonary rehabilitation

Initiate group visits

Use disease registry of patients with COPD


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Group visits

Elements

Group discussion

Clinical component Develop action plan


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Group Visits Preparation

Secure support of organization's administration Address billing and any other system issues

Establish health care team Establish threshold for minimum census for meeting Recognize not ideal for all patients Customize sessions to each physician and patient

panel Establish procedures for meeting Identify comfortable place that has exam room nearby


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Group visits

Implementation

Address billing and any other system issues

Recruit patients Begin the shared medical appointment

Allow time for private consultation

Document the visit

Evaluate overall program

Realize focus on mind and body


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Group visits

Common Features

Voluntary

Interactive Care delivery systems - NOT classes

Intended to enlist and validate patients as their owncaregivers

Efficient and effective


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Patient diaries Should include:

Doctor visits, lab test results, and therapy milestones

Symptoms, including mucus production

Use of medication

Any over-the-counter medications taken that week, includingvitamins, herbals, and supplements

Notes to patient or doctor

Provide more objective tool for use in treatmentdecisions (SOR: B)

Vijayasaratha,2008


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References Cranston JM, Crockett A, Moss J, Alpers JH, Cranston JM. Domiciliary

oxygen for chronic obstructive pulmonary disease (Cochrane Review). In:The Cochrane Library 2008 Issue 4. Chichester, UK: John Wiley and Sons,Ltd.

Evensen AE. Management of COPD exacerbations [published correctionappears in Am Fam Physician. 2010;82(3):230]. Am Fam Physician.2010;81(5):607-613.

deJong YP, Uil SM, Grotjohan HP, Postma DS, Kerstjens HAM, van denBerg JWK. Oral or IV prednisolone in the treatment of COPDexacerbations. Chest. 2007;132(6):1741-7.

Global Initiative for Chronic Obstructive Lung Disease (GOLD). Globalstrategy for the diagnosis, management, and prevention of chronic

obstructive pulmonary disease. Bethesda, Md.: Global Initiative for ChronicObstructive Lung Disease (GOLD), 2009:1-93.


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References - Continued Kerstjens HA, Bantje TA, Luursema PB, et al. Effects of short-acting

bronchodilators added to maintenance tiotropium therapy. Chest.2007;132(5):1493-1499.

Lee TA, Wilke C, Joo M, et al. Outcomes associated with tiotropium use inpatients with chronic obstructive pulmonary disease. Arch Intern Med.2009;169(15):1403-1410.

Celli B, Decramer M, Leimer I, Vogel U, Kesten S, Tashkin DP.Cardiovascular safety of tiotropium in patients with COPD. 2010;137(1):20-30.

Lindenauer PK, Pekow PS, Lahti MC, Lee Y, Benjamin EM, Rothberg MB.Association of corticosteroid dose and route of administration with risk oftreatment failure in acute exacerbation of chronic obstructive pulmonary

disease. JAMA. 2010;303(23):2359-2367.

R f C ti d


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References - Continued

Ogale SS, Lee TA, Au DH, Boudreau DM, Sullivan SD. Cardiovascular events

associated with ipratropium bromide in COPD. Chest. 2010;137(1):13-19. Peytremann-Bridevaux I, Staeger P, Bridevaux PO, Ghali WA, Burnand B.

Effectiveness of chronic obstructive pulmonary disease-management programs:systemic review and meta-analysis. Am J Med. 2008;121(5):433-443.e4.

Rabe KF, Hurd S, Anzueto A, et al., for the Global Initiative for ChronicObstructive Lung Disease. Global strategy for the diagnosis, management, andprevention of chronic obstructive pulmonary disease: GOLD executivesummary. Am J Respir Crit Care Med. 2007;176(6):532-555.

Rutten FH, Zuithoff NP, Hak E, Grobbee DE, Hoes AW. Beta-blockers mayreduce mortality and risk of exacerbations in patients with chronic obstructivepulmonary disease. Arch Intern Med. 2010;170(10):880-887.


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References - Continued

Salpeter SR, Ormiston TM, Salpeter EE. Cardioselective beta-blockers for

chronic obstructive pulmonary disease. Cochrane Database of SystematicReviews 2005, Issue 4.

Singh S, Loke YK, Furburg CD. Inhaled anticholinergics and risk of majoradverse cardiovascular events in patients with chronic obstructive pulmonarydisease: a systematic review and meta-analysis [published correction appears inJAMA. 2009;301(12):1227-1230]. JAMA. 2008;300(12):1439-1450.

Sutherland ER, Cherniack RM. Management of chronic obstructive pulmonarydisease. N Engl J Med. 2004;350(26):2689-2697.

Tashkin DP, Celli B, Senn S, et al., for the UPLIFT Study Investigators. A 4-yeartrial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med.2008;359(15):1543-1554.

Vijayasaratha K, Stockley RA. Reported and unreported exacerbations ofCOPD: analysis by diary cards. Chest. 2008;133(1):34-41.

COPD Patient Intervention Module

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