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COPD: Patient Intervention

COPD: Patient Intervention. Peter J. Carek, MD, MS Program Director, Trident/MUSC Family Medicine Residency, Charleston, SC Lori M. Dickerson, PharmD Associate Program Director, Trident/MUSC Family Medicine Residency, Charleston, SC. Educational Objectives.

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COPD: Patient Intervention

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  1. COPD: Patient Intervention Peter J. Carek, MD, MS Program Director, Trident/MUSC Family Medicine Residency, Charleston, SC Lori M. Dickerson, PharmDAssociateProgram Director, Trident/MUSC Family Medicine Residency, Charleston, SC

  2. 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 of COPD disease management programs and group visits • Provide instruction in use of patient diaries

  3. Pharmacologic Therapy Goals • Prevent and control symptoms • Reduce frequency and severity of exacerbations • Improve health status • Improve exercise tolerance

  4. Short-acting inhaled bronchodilator for acute relief of symptoms Symptoms Oxygen therapy FEV1 Supplemental Therapy Pulmonary rehab Combination of inhaled corticosteroid, long-acting β-agonist, and long-acting anticholinergic Combination of anticholinergic and β-agonist bronchodilator Stepwise Drug Therapy Pneumococcal and annual influenza vaccination, smoking cessation and regular assessment of lung function Health Care Maintenance Adapted from Sutherland, 2004

  5. Pharmacologic Therapy Oxygen therapy • Used as long-term continuous therapy, during exercise, or to relieve acute dyspnea • Improves survival in COPD patients with severe hypoxemia (partial pressure of oxygen [pO2] < 55 mm Hg or oxygen saturation [sO2] <88%) (Strength of Recommendation [SOR]: A) • When used for >15 hours daily • Does not improve survival in patients with moderate hypoxemia or desaturation at night Cranston, 2008 GOLD, 2009

  6. Pharmacologic Therapy Oxygen therapy • Candidates include patients with very severe COPD who have walking pO2 … • ≤ 55 mm Hg or oxygen saturation less than 88%, with or without hypercapnia (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

  7. Pharmacologic Therapy Oxygen therapy • Titrate to pO2 of at least 60 mm Hg or oxygen saturation of at least 90%. • Beware of pushing O2 saturation too high - can turn off the respiratory drive in CO2 retainers Cranston, 2008 GOLD, 2009

  8. Pharmacologic Therapy Bronchodilators • Foundation of symptomatic treatment • Improve airflow and hyperinflation, decrease work of breathing and 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

  9. Pharmacologic Therapy • Beta agonists - Mechanism of action • Stimulate ß2-adrenergic receptors, increasing cyclic AMP and relaxing airway smooth muscle Rabe, 2007; GOLD, 2009

  10. Pharmacologic Therapy • Anticholinergics - Mechanism of action • Block effect of acetylcholine on muscarinic-type 3 receptors, resulting in bronchodilation. Rabe, 2007; GOLD, 2009

  11. Pharmacologic Therapy 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) than albuterol (4-6 hours) (SOR: A) • Ipratropium not used alone for rescue, but is used for maintenance. • Combination slightly better bronchodilation than either agent alone (SOR: A) Rabe, 2007 GOLD, 2009

  12. Pharmacologic Therapy Long-acting bronchodilators • For moderate airflow limitation, use scheduled long-acting bronchodilator • Relieve symptoms, increase exercise tolerance, reduce exacerbations, improve quality of life (SOR: A) • Once- or twice-daily dosing • Must be given with short-acting bronchodilator for acute relief of symptoms Rabe, 2007 GOLD, 2009

  13. Pharmacologic Therapy Bronchodilator - Adverse effects • ß2-agonists • Tachycardia, palpitations, muscle tremors/cramping, insomnia • Hypokalemia, prolonged QT interval, hyperglycemia • Levalbuterol offers no advantage to albuterol (SOR: A) • Anticholinergics • Dry mouth, constipation • Similar adverse effects with short- and long-acting agents Rabe, 2007 GOLD, 2009

  14. Pharmacologic Therapy Long-Acting β2 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

  15. Pharmacologic Therapy Long-acting anticholinergics • Tiotropium has once daily dosing, duration of action > 24 hours (SOR: A) • In patients with moderate to severe COPD • Delayed time to first exacerbation (16.7 vs. 12.5 months) • Reduced exacerbation days per patient-year (12.11 vs. 13.64) • Did not affect mortality • Insufficient evidence to recommend one long-acting bronchodilator over another • Tiotropium vs. salmeterol Tashkin, 2008 GOLD, 2009

  16. Pharmacologic Therapy Long-acting anticholinergics • Short-acting beta2-agonists (ie, albuterol) are recommended for relief of symptoms (SOR: A) • Should not use short-acting anticholinergics (ie, ipratropium) for relief of symptoms if also using long-acting anticholinergic Kerstjens, 2007 GOLD, 2009

  17. Pharmacologic Therapy Anticholinergics and cardiovascular events • In meta-analyses, anticholinergic agents have been associated with cardiovascular events • Ipratropium > tiotropium (SOR: B) • Significant limitations to study • Large, prospective randomized controlled trial of tiotropium found no association with cardiovascular events • Singh, 2008 • Celli, 2010 • Ogale, 2010

  18. Pharmacologic Therapy Inhaled bronchodilators - Summary • Stick with the GOLD guidelines • Use short-acting bronchodilators as needed for symptoms (SOR: A) • When regular use is needed, long-acting bronchodilators are more effective and convenient (SOR: A) • Consider the patient’s baseline cardiovascular risk before prescribing an anticholinergic (SOR: C) • Encourage smoking cessation

  19. Pharmacologic Therapy 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

  20. Pharmacologic Therapy 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 oral steroids to identify COPD patients who might benefit from inhaled steroids (SOR: A) • Poor predictor of long-term response to inhaled steroids in COPD Rabe, 2007 GOLD, 2009

  21. Pharmacologic Therapy 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 COPD Rabe, 2007 GOLD, 2009

  22. Pharmacologic Therapy 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

  23. Pharmacologic Therapy 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 (0.03 – 0.34 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

  24. Pharmacologic Therapy 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, 0.69 – 0.89) • Over 5-year period, patients with severe disease having 2 exacerbations per year would have 8 instead of 10 exacerbations if they used ICS • FEV1 > 50% predicted (less severe disease) • No significant change in exacerbation risk. Relative risk of exacerbations 1.03 (95% CI, 0.86 – 1.23) Agarwal, 2010

  25. Pharmacologic Therapy ICS - Adverse effects • Local • Candidiasis and dysphonia • Rinse after use to reduce risk • Systemic absorption with high dose • 1,000 mcg fluticasone per day • Skin bruising, cataracts, reduced bone mineral density Rabe, 2007 GOLD, 2009

  26. Pharmacologic Therapy 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, 1.33 – 1.92) • Relative risk of serious pneumonia 1.71 (95% CI, 1.46 – 1.99) • No increase in pneumonia-related mortality Calverley, 2007 Singh, 2008

  27. Pharmacologic Therapy 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 little advantage in terms of exacerbations (SOR: A) • Reserve for patients with severe COPD (FEV1 < 50% predicted) (SOR: A)

  28. Pharmacologic Therapy 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 or tiotropium 18 mcg daily • Salmeterol/fluticasone associated with exacerbations requiring antibiotics • Tiotropium associated with exacerbations requiring oral steroids Wedzicha, 2008

  29. Pharmacologic Therapy LABA/ICS plus tiotropium • Cohort study of Veteran’s 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, bias Lee, 2009

  30. Which of the following pharmacologic treatments has been shown to improve mortality in patients with COPD? A. Short-acting inhaled beta2-agonists B. Inhaled corticosteroids C. Oxygen D. Long-acting inhaled anticholinergics

  31. Which of the following pharmacologic treatments has been shown to increase FEV1 long term in patients with COPD? A. Short-acting inhaled beta2-agonists B. Inhaled corticosteroids C. Long-acting inhaled anticholinergics D. None of the above

  32. Pharmacologic Therapy Beta blockers in COPD • Medical myth – Beta blockers are contraindicated in COPD • No significant adverse respiratory effects with cardio-selective beta blockers in patients with mild-moderate reversible airway disease or COPD • Atenolol, bisoprolol, metoprolol • Use of beta blockers decreased mortality and exacerbations in patients with COPD • Even in absence of overt cardiovascular disease Salpeter, 2005 Rutten, 2010

  33. Pharmacologic Therapy Acute exacerbations • Bronchodilator therapy • Improve airflow (i.e. FEV1) and symptoms during acute exacerbations (SOR: A) • Use short-acting beta2-agonist (albuterol) or combination beta2-agonist and anticholinergic • Metered dose inhaler (MDI) + spacer as effective as nebulized delivery (SOR: C) • Training on MDI technique essential • Coordination in elderly patients may hinder use • Nebulized delivery provides subjective benefit without difference in FEV1 in acute exacerbations (SOR: B) GOLD, 2009 Evensen, 2010

  34. Pharmacologic Therapy Systemic corticosteroids • Shorten recovery time, improve FEV1 and hypoxemia (SOR: A) • May reduce risk of early relapse, treatment failure, and length of hospitalization Rabe, 2007 GOLD, 2009

  35. Pharmacologic Therapy 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 oral medications • Intravenous administration • Reserved for critically ill patients • No role for inhaled corticosteroids in acute exacerbations deJong, 2007 Lindenauer, 2010

  36. Pharmacologic Therapy 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

  37. Pharmacologic Therapy 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, taking steroids 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, then stop.

  38. Pharmacologic Therapy Antibiotics • Beneficial for patients presenting with an increase in any of the following three symptoms (SOR: B) • Dyspnea • Sputum volume • Sputum purulence • Beneficial for patients with severe exacerbations requiring mechanical ventilation (SOR: B) • Treatment should be given for 3-7 days (SOR: C) Rabe, 2007 GOLD, 2009

  39. Pharmacologic Therapy Antibiotic Regimens GOLD, 2009

  40. Pharmacologic Therapy 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 cessation Rabe, 2007 GOLD, 2009

  41. 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

  42. Nonpharmacologic Therapy Disease management • Improve use of spirometry • Ensure patients receive adequate vaccines • Educate patients and provide tools to manage their COPD • Refer patients to pulmonary rehabilitation • Initiate group visits • Use disease registry of patients with COPD

  43. Nonpharmacologic Therapy Group visits • Elements • Group discussion • Clinical component • Develop action plan

  44. Nonpharmacologic Therapy 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

  45. Nonpharmacologic Therapy 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

  46. Nonpharmacologic Therapy Group visits • Common Features • Voluntary • Interactive • Care delivery systems - NOT classes • Intended to enlist and validate patients as their own caregivers • Efficient and effective

  47. Nonpharmacologic Therapy 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, including vitamins, herbals, and supplements • Notes to patient or doctor • Provide more objective tool for use in treatment decisions (SOR: B) Vijayasaratha,2008

  48. Nonpharmacologic Therapy Patient education • Quit smoking • Exercise every day • Eat a healthy diet • Take medicines as directed • Get vaccinated • Flu shot every year • Pneumonia shot

  49. 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 correction appears 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 den Berg JWK. Oral or IV prednisolone in the treatment of COPD exacerbations. Chest. 2007;132(6):1741-7. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Bethesda, Md.: Global Initiative for Chronic Obstructive Lung Disease (GOLD), 2009:1-93.

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