Faculty Affiliation. Faculty Disclosures. Maintenance Therapy for Patients with COPD in Longterm Care Settings

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1 Maintenance Therapy for Patients with COPD in Longterm Care Settings Sponsored by Integrity Continuing Education, Inc. Supported Practitioner s by Edge an is educational a registered service grant from mark of Sunovion Integrity Continuing Pharmaceuticals, Education, Inc. Inc. 213 Integrity Continuing Education, Inc. 1 1 Faculty Affiliation Meenakshi Patel, MD Associate Professor of Medicine Department of Medicine Division of Geriatrics Boonshoft School of Medicine Wright State University Owner Valley Medical Primary Care Dayton, Ohio 2 Faculty Disclosures Consultant: Acadia, Sanofi, Sunovion Pharmaceuticals Inc. Research support: AstraZeneca, Avanir, Avid, GlaxoSmithKline, Janssen, Lundbeck, Navidea, Pfizer, Sanofi, Suven, Takeda Speaker: Actavis, Avanir, Boehringer Ingelheim, GlaxoSmithKline, Sanofi, Sunovion Pharmaceuticals Inc. Collegium, Acadia Sponsored by Integrity Continuing Education, Inc. Supported by an educational grant from Sunovion Pharmaceuticals, Inc. 3 1

2 Reminder Complete Session Pre- and Post-Test Complete Online Session Evaluation at End of Session **Links found in Event App 4 Learning Objectives Identify patients with chronic obstructive pulmonary disease (COPD) who are not receiving long-acting bronchodilators as maintenance treatment in longterm care (LTC) settings Evaluate physical and cognitive limitations in patients with COPD Assess the advantages and disadvantages of medication delivery options for patients needing long-acting bronchodilator therapy Implement a management plan for patients with COPD in LTC settings 5 COPD in Long-term Care Settings Epidemiology and General Management 2

3 COPD in LTC Settings Retrospective analysis of US nursing home residents (N=126,121) 21.5% had a diagnosis of COPD Clinical profile: 62.% had a short-term memory impairment 43.3% had moderate-to-severe cognitive impairment for daily decision making >65% had significant physical impairment* COPD No COPD *Required extensive assistance or were dependent on staff for bed mobility, transfer, dressing, and personal hygiene. Zarowitz BJ, et al. J Manag Care Pharm. 212;18(8): COPD is Associated with More ED Visits and Hospital Stays Among RCF Residents COPD No COPD Percent At Least 1 Hospital Emergency Room Visit 3 or More Hospital Emergency Room Visits Overnight Stay in Hospital ED, emergency department; RCF, residential care facility. Wheaton AG, et al. J Aging Health. 215;27(3): Management of COPD in Nursing Homes Percent Residents* with COPD who received no respiratory medication Residents* treated for COPD, but who experienced 2 acute exacerbations during the 12-month study 17.% 2.% Residents* who did not receive guideline recommended therapy consisting of an inhaled LABA/ICS combination 6.% *Residents of the nursing homes included in the study had significant cognitive impairment. LABA, long-acting beta 2-agonist, ICS, inhaled corticosteroid. Zarowitz BJ, et al. J Manag Care Pharm. 212;18(8):

4 General Approach to COPD Management in LTC Settings Recognition Assessment Treatment Monitoring Screen new patients for COPD and COPD risk factors Rule out other conditions Evaluate severity and stability of COPD Determine patient functional status Tailor maintenance therapy plan (pharmacologic & nonpharmacologic) Manage exacerbations Address comorbidities Monitor symptoms and functional capacity Monitor the use of COPD medications Evaluate facility management of COPD AMDA-PA/LTC Guidelines 216 update. 11 Identification of Patients with COPD Indicators of COPD Risk Exposures Tobacco smoke (smoking or passive) Dusts, chemical agents, or fumes Medical history Recurrent pneumonia or chronic bronchitis Sleep-disordered breathing Anxiety or depression Cognitive impairment Clinical indicators Dyspnea affecting performance of ADLs Sputum production Weight loss or gain Use of supportive ventilation devices (eg, CPAP or bipap) or respiratory equipment Hospitalization for respiratory difficulties ADLs, activities of daily living; CPAP, continuous positive airway pressure; bipap, bilevel positive airway pressure. AMDA-PA/LTC Guidelines 216 update; Vestbo J, et al. GOLD 216 update; Gooneratne et al. JAGS. 21;58: ; Wise RA. Am J Med. 26; 119(1, suppl 1):

5 Key Indicators for a Diagnosis of COPD Symptoms Progressive dyspnea (worsens over time with exercise) Chronic cough Sputum History of Exposure to Risk Factors Tobacco smoke Smoke from household fuels Occupational dusts and chemicals Family History of COPD Spirometry is required to diagnose COPD: post-bronchodilator FEV 1 /FVC <.7 confirms the presence of persistent airflow limitation. FEV 1. forced expiratory volume in 1 second; FVC, forced vital capacity. Adapted from: Vestbo J, et al. GOLD 216 update. 14 COPD Severity and Risk Assessment Case Study #1: Patient Background An 82-year-old male admitted to a SNF following a recent hospitalization for COPD History: Current smoker Presentation: Difficulty moving around Persistently out of breath Requires assistance with ADLs Significant memory impairment Refuses to see a PCP since his wife died a year ago Increasingly neglectful of health SNF, skilled nursing facility; PCP, primary care provider. 16 5

6 Case Study #1: Discussion What is your initial approach to evaluation of the patient at the facility? Do you use any COPD assessments? What tests would you order? Do you check the EMR for past progress notes or PFTs? Do you request a pulmonology consult? EMR, electronic medical record; PFT, pulmonary function test. 17 Estimation of COPD Severity Not Always Aligned with Objective Measures Estimated COPD severity is inconsistent with objective measures in a significant percentage of patients: Assessment of Severity Patients (%) Physician < Spirometry 41 Physician = Spirometry 3 Physician > Spirometry 29 Spirometry resulted in a change in treatment in ~33% of patients Mapel DW, et al. Am J Med. 215;128(6): AMDA Guidelines for Combined COPD Assessment Group A (Low risk, fewer symptoms) Grade 1 or 2 (mild or moderate airflow limitation) AND/OR to 1 exacerbations/year and no hospitalizations* AND CAT <1 or mmrc to 1 Group C (High risk, fewer symptoms) Grade 3 or 4 (severe or very severe airflow limitation) AND/OR 2 exacerbations/year or 1 hospitalization* AND CAT <1 or mmrc to 1 Group B (Low risk, more symptoms) Grade 1 or 2 (mild or moderate airflow limitation) AND/OR to 1 exacerbations/year and no hospitalizations* AND CAT >1 or mmrc 2 Group D (High risk, more symptoms) Grade 3 or 4 (severe or very severe airflow limitation) AND/OR 2 exacerbations/year or 1 hospitalization* AND CAT >1 or mmrc 2 *For an exacerbation. CAT, COPD Assessment Test; mmrc, modified Medical Research Council Breathlessness Scale. AMDA-PA/LTC Guidelines 216 update. Vestbo J, et al. GOLD 216 update. 19 6

7 Modified MRC (mmrc) Questionnaire 2 COPD Assessment Test (CAT) 21 COPD is Associated with Increased Risk for Comorbidities Among RCF Residents Residents with Condition (%) No COPD COPD AD, Alzheimer's disease; RA, rheumatoid arthritis; CHD, congenital heart defect; CHF, chronic heart failure; MI, myocardial infarction. Wheaton AG, et al. J Aging Health. 215;27(3):

8 Comorbidities Increase Risk of Disease Progression and Future Exacerbations CHF OSTEOPOROSIS LUNG CANCER SKELETAL MUSCLE WEAKNESS COPD PROGRESSION AND FUTURE EXACERBATION ANXIETY DEPRESSION Vestbo J, et al. GOLD 216 update. 23 Exacerbations of COPD Diagnosis and Treatment COPD Exacerbation An exacerbation of COPD is an acute event characterized by a worsening of the patient s respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication. Vestbo J, et al. GOLD 216 update. 25 8

9 Confirming the Diagnosis of a COPD Exacerbation Patient History Diagnosis of COPD Cigarette smoking Dyspnea on ordinary exertion, shortness of breath at rest Cough, phlegm Physical Exam Wheezing on lung exam Decreased breath sounds Use of accessory muscles Pursed-lip breathing Hyperinflation Courtesy of Dr. Robert Wise, MD, Johns Hopkins Medicine, Johns Hopkins Bayview Medical Center. Diagnostic Testing SpO 2 <88% on room air Abnormal chest X-ray Hyperinflation on chest imaging 26 Initial Treatment of an Exacerbation O2 therapy NIV/IMV Bronchodilator therapy Increase doses/frequency of SABA therapy Combine SABAs with anticholinergics Use spacers or air-driven nebulizers Oral corticosteroids Antibiotics for infectious exacerbations Adjunctive therapies NIV, noninvasive ventilation; IMV, invasive mechanical ventilation; SABA, short-acting bronchodilator. Vestbo J, et al. GOLD 216 update Day Course of Corticosteroids Preferred for COPD Exacerbations GOLD Stage 3-4 FEV 1 ~31% predicted Randomized to 5 or 14 days of prednisone (4 mg) 5-day regimen noninferior to 14-day regimen Hospital stays averaged 1 day shorter with 5-day regimen Patients Without Exacerbation (%) days Short-term group Conventional group 14 days Time From Inclusion (days) GOLD, Global Initiative for Chronic Obstructive Lung Disease. Leuppi JD, et al. JAMA. 213;39(21):

10 Association of Disease Severity with Frequency of COPD Exacerbations ECLIPSE Study 5 Hospitalized for exacerbation in year 1 Frequent exacerbations 47 Patients (%) GOLD 2 (N=945) GOLD 3 (N=9) GOLD 4 (N=293) ECLIPSE, Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints. Hurst JR, et al. N Engl J Med. 21;363(12): Cognitive Dysfunction in Patients Hospitalized for an Exacerbation Percent Processing speed index (P=.2) Working memory index (P=.8) COPD-E COPD-S Controls Patients with an exacerbation exhibited: 57% cognitive impairment 2% pathological loss of processing speed COPD-E, patients with acute COPD exacerbation; COPD-S patients with stable COPD. Dodd, et al. CHEST. 213;144(1): Recovery from COPD Exacerbation is Often Incomplete Stable COPD Exacerbation Daily AM PEFR as % Baseline Post hospital discharge recovery phase PEFR, peak expiratory flow rate. Days Seemungal, et al. Am J Respir Crit Care Med. 2;161:

11 Considerations for Patients Transitioning from the Hospital/Post-acute Care Setting Increased risk for mortality following an exacerbation Reassess disease severity and/or risk for future exacerbations Assess efficacy of the current therapeutic regimen Initiate long-acting bronchodilator maintenance therapy in hospital/postacute setting Change(s) in current therapy or delivery method of medications Referral to pulmonologist Assess need for palliative or hospice care AMDA-PA/LTC Guidelines 216 update; Groenewegen KH, et al. Chest (2): ; Connors AF, Jr, et al. Am J Respir Crit Care Med. 1996;154(4 Pt 1): Odds of Readmission 31% Lower When Nebulized LABA Initiated in Hospital Overall, significantly lower (8.7% vs 11.9%) 3-day readmissions with arformoterol Readmission Rate (%) Neb-SABA Arformoterol P= P= P= P= Minor Moderate Major Extreme Severity of Illness 9.9 Neb-SABA, nebulized SABA. Bollu V, et al. Int J Chron Obstruct Pulmon Dis. 213;8: Hospital Stays for Exacerbations of COPD Following Initiation of LAMA Hospital Stay (± SD, days) P<.5 * January February March Jan-Mar Combined Early addition of maintenance LAMA (tiotropium) to a respiratory-therapistdirected bronchodilator protocol for patients hospitalized for COPD exacerbation reduced: Hospital stays Hospital costs No safety concerns SD, standard deviation. LAMA, long-acting muscarinic antagonist. Drescher GS, et al. Respir Care. 28;53(12):

12 COPD Exacerbations in the LTC Setting LTC Facility Staff Recognition and report of the exacerbation Implementation of prn orders for rescue medications Assessment of episode severity Practitioner notification LTC Practitioner Confirmation of the exacerbation Evaluation for hospitalization Additional treatment if required: Oral corticosteroids Antibiotics Adjunctive therapies LTC Facility Staff Following resolution, tapering or discontinuation of medications prescribed for the exacerbation Follow-up with the practitioner prn, as needed. AMDA-PA/LTC Guidelines 216 update. 35 Warning Signs that Your Patient is at Risk for an Exacerbation Daily use of SABA or SABA/SAMA treatments as maintenance therapy Absence of long-acting bronchodilator maintenance therapy O 2 saturation dropping or O 2 therapy demand increases Escalating daily symptom burden Respiratory infection Increased antitussive medication use Shortness of breath while ambulating or moving around in a wheelchair Decreased time in ADLs or therapy SAMA, short-acting muscarinic antagonist. Bahadori et al. Int J Chron Obstruct Pulmon Dis. 27;2(3): Treatment of COPD Maintenance Therapy 12

13 Case Study #1: Discussion (cont d) After stabilization, the patient receives a nebulized SABA/SAMA at discharge and continues treatment in the SNF What is your next step for the patient? No change in therapy Continue SABA/SAMA and add tiotropium DPI Discontinue SABA/SAMA and add one or more of the following SABA prn by nebulizer LABA by nebulizer twice daily LABA/LAMA LABA/ICS DPI, dry powder inhaler. 38 The Majority of Medicare Patients with COPD Do Not Receive Long-term Pharmacotherapy 7.9% of patients received no long-term pharmacotherapy SABA alone; 4.9% SAAC; 8.9% ICS; 1.6% LAAC; 1.3% SAAC + ICS; 2.9% LABA + ICS; 4.2% Ach + LABA + ICS; 9.7% Other combinations; 4% No medication or treatment; 66% Medicare patients with COPD (N = 857) Mean age = 74.8 ± 7.3* *>93% of patients were 65 years of age; US Medicare population. Ach, anticholinergic; LAAC, long-acting anticholinergic; SAAC, short-acting anticholinergic. Make B, et al. Int J Chron Obstruct Pulmon Dis. 212;7: Treatment of COPD in LTC Settings is Not Aligned with Current Guidelines Patients with COPD (%) SABA, HHD 9.1 SABA, nebulized 1.9 SAMA, inhalers 23.4 SAMA, nebulized LABA, HHD LABA, nebulized 22 LAMA, HHD Short-acting Therapies Long-acting Therapies HHD, hand-held device. Zarowitz BJ, et al. J Manag Care Pharm. 212;18(8):

14 Delays in Maintenance Therapy Are Associated with Increased Risk for Future Exacerbations 5. Early Delayed 46.2 Proportion of Patients With Exacerbation (%) * * Hospital ED Phy + Rx Hospital/ED Any Type of COPD Exacerbation *P <.1; P <.1 Dalal AA, et al. Am J Manag Care. 212;18(9):e338-e GOLD Recommendations for Pharmacotherapy Patient Group A Recommended First Choice SAMA prn or SABA prn Alternative Choice LABA or LAMA or SABA + SAMA B LAMA or LABA LAMA + LABA Other Possible Treatments Theophylline SABA and/or SAMA Theophylline C ICS + LABA or LAMA LAMA + LABA or LAMA + PDE4 or LABA + PDE4 SABA and/or SAMA Theophylline D ICS + LABA and/or LAMA ICS + LABA + LAMA or ICS + LABA + PDE4 or LABA + LAMA or LAMA + PDE4 Carbocysteine SABA and/or SAMA Theophylline PDE4, phosphodiesterase type 4 inhibitor. Vestbo J, et al. GOLD 216 update. 42 Approved Long-acting Bronchodilator Monotherapies LABA LAMA Agent Arformoterol Formoterol Indacaterol Olodaterol Salmeterol Aclidinium Tiotropium Umeclidinium Glycopyrronium Delivery Nebulizer Nebulizer DPI DPI SMI DPI DPI DPI, IS DPI DPI IS, inhalation spray; SMI, soft mist inhaler. Vestbo J, et al. GOLD 216 update

15 Approved Fixed-dose Combinations LABA/LAM A LABA/ICS Agent Vilanterol + umeclidinium Olodaterol + tiotropium Indacaterol + glycopyrronium bromide Formoterol + budesonide Salmeterol + fluticasone Vilanterol + fluticasone Formoterol + mometasone* Delivery DPI SMI DPI MDI DPI DPI MDI *Off-label use. Not indicated for the treatment of patients with COPD. MDI, metered dose inhaler. Vestbo. J, et al. GOLD 216 update. 44 AMDA-PA/LTC Guiding Principles for COPD Pharmacotherapy General Guidance Combine with nonpharmacologic approaches Select based upon AE profiles Employ lowest effective doses Bronchodilator Choice Opt for long-acting agents, which are more effective and convenient vs short-acting agents Provide access to short-acting beta 2 agonists for rescue therapy Consider combining pharmacologic classes to improve efficacy and decrease AEs vs single agent dose escalation Choose delivery systems to meet individual patient needs Treatment Considerations Maintain treatment level unless significant AEs occur or revised management is needed (eg, for increased symptom burden and exacerbations) Provide additional medications as appropriate as disease state progresses Train patients and caregivers to properly administer inhaled medications Assess therapeutic response and AEs with goals of therapy and adjust treatment accordingly AE, adverse event. AMDA-PA/LTC Guidelines 216 update. 45 Treatment of COPD Considerations for Choosing a Maintenance Therapy 15

16 Case Study #2: Patient Background An 85-year-old female nursing home resident with COPD (GOLD 3) presents to the hospital for an exacerbation Presentation: Productive cough Unable to catch her breath for several hours History over the past week (from LTC nurse practitioner): Increased frequency of coughing Patient reporting a cold Albuterol increased from prn to every 4 hours 47 Case Study #2: Patient Background Other medical history: Mild dementia Osteoarthritis (hands, shoulder, feet) HTN PVD HTN, hypertension; PVD, peripheral vascular disease. 48 Case Study #2: Discussion Patient was initiated on antibiotics and corticosteroids (in the hospital) How would you approach management of the patient upon return to the LTC facility? Consider long-acting bronchodilator maintenance therapy What factors would you take into consideration in choosing a therapy Discuss strategies to maintain patient and prevent hospitalization during the critical post-exacerbation window 49 16

17 Factors Influencing Appropriate Use of Inhaled Therapy in Older Individuals Physical Factors Loss of physical strength Worsening hypoxia or hypercapnia from COPD Cognitive Factors Cognitive impairment Mood disorder Additional Factors Comorbid conditions Complexity of regimen Taffet GE, et al. Clin Interv Aging. 214;9: Activities Requiring Assistance Among LTC Residents Residents Requiring Task Assistance (%) Bathing Walking or locomotion Dressing Toileting Transferring in or out of bed Eating Residential Care Community Harris-Kojetin L, et al. Vital Health Stat. 216;3(38). Nursing home 51 Inspiratory Flow Rates in Patients with COPD Approximately 1 in 5 patients with advanced COPD and 6 years old exhibit suboptimal PIFR against DPI resistance (<6 L/min) 1 Arformoterol treatment resulted in greater lung function improvements vs salmeterol at 15 minutes in patients with suboptimal PIFR 2 Arformoterol Salmeterol P value ΔFEV 7 ± ± 74.2 ΔFVC 163 ± ± ΔIC 17 ± ± Patients with suboptimal PIFR may have difficulty actuating a DPI, which may reduce medication delivery PIFR, peak inspiratory flow rate; IC, inspiratory capacity. 1. Mahler DA, et al. J Aerosol Med Pulm Drug Deliv. 213;26(3): Mahler DA, et al. J Aerosol Med Pulm Drug Deliv. 214;27(2):

18 Older Patients Are at Increased Risk for Medication Device Errors Among patients with COPD and 65 years of age, critical errors were made during 79% of pmdi observations and 88% of DPI observations Successful DPI and pmdi (graph) use decreases with increasing age Rate of Successful pmdi Use (%) P< >75 Age (years) pmdi, pressurized metered dose inhaler. Mahler DA, et al. J Aerosol Med Pulm Drug Deliv. 213;26(3): ; Vanderman AJ, et al. Consult Pharm. 215;3(2): 92-1; Wieshammer S, et al. Respiration. 28;75(1):18-25; Giraud V, et al. Eur Respir J. 22;19(2): Specific Characteristics Associated with Incorrect MDI Use Among the Elderly Characteristic Correct Users Incorrect Users P Value Age (y) 67.2± ±7.7.1 M (%) F (%) MMSE Score (pt) 26.2± ±3.7.2 Education (y) 1.2±3 9.6±3.4 Tip pinch gauge (lb) 12.7± ±3.3.1 Palmar pinch gauge (lb) 16± ±3.3.1 Dynamometer (lb) 72.3± ± Note: The pinch gauge measures the strength between the thumb and fingers, whereas the dynamometer measures overall hand strength. MMSE, mini-mental status examination. Gray SL, et al. Arch Intern Med. 1996;156(9): Strategies for Addressing Difficulties with Administration of Inhaled Medications Problem Lack of hand-breath coordination Lack of hand strength and dexterity Approach Use a spacer for MDI or consider DPI or nebulizer Use a spacer for MDI or consider nebulizer Difficulty generating an adequate inspiratory force Consider using an MDI or nebulizer Possible cognitive impairment Multiple inhaler regimen Have the patient demonstrate proper technique Evaluate cognitive impairment (AMTS or MMSE) Ensure proper technique and use Involve caregivers in counseling sessions AMTS, abbreviated mental test score. Nobles J, et al. Consult Pharm. 214;29(11):

19 Treatment of COPD Nonpharmacologic Interventions Smoking Cessation Decreases the Rate of Lung Function Decline Among Patients with COPD ml/yr Sustained quitters Continuing smokers FEV 1 (litres) ml/yr Year Scheme of mean changes in FEV 1 in continuing smokers and sustained quitters in the Lung Health Study. Scanlon PD, et al. Am J Respir Crit Care Med. 2;161(2, pt 1): Components of a Comprehensive Pulmonary Rehabilitation Program Smoking cessation As noted, most important therapeutic intervention Health benefits are immediate and substantial Exercise training Significant improvements of dyspnea, health-related QOL, and mobility, and decreased loss of lung function Nutrition counseling COPD-related malnutrition is frequently observed May contribute to wasting of peripheral and respiratory muscles involved in breathing or immune impairment Education of the patient and family members about the disease QOL, quality of life. Vestbo, J, et al. Am J Respir Crit Care Med. 213;187(4):

20 Pulmonary Rehabilitation Reduces COPD Exacerbation Frequency Mean No. of Exacerbations * *P<.5. * Exacerbations Hospitalizations Exacerbations Out of Hospital * Pre-PR Post-PR Mean number of exacerbations (total), hospitalizations, and exacerbations out of hospital 1 year before and 1 year after PR. PR, pulmonary rehabilitation. van Ranst D, et al. Int J Chron Obstruct Pulmon Dis. 214;9: Vaccinations to Prevent Future COPD Exacerbations Influenza vaccines respiratory tract infections that result in hospitalization and death in patients with COPD Pneumococcal vaccines rate of community-acquired pneumonia in COPD patients Pneumococcal infections result in a significant percentage of acute exacerbations of COPD Vaccinations remain highly underused 38.4% of patients with COPD admitted to a university medical center had a prior influenza vaccine Only half of eligible patients presenting with an exacerbation to a set of urban hospitals had influenza and pneumococcal vaccines Yip NH, et al. COPD. 21;7(2): Nantsupawat T, et al. Chron Respir Dis. 212;9(2): Long-term Monitoring of COPD 2

21 The Importance of Long-term Monitoring Regular patient reassessment is vital due to the progressive nature of COPD Reassessment should occur regularly or when the patient s condition changes: Physical status and overall functioning Adherence to therapy Pharmacologic and nonpharmacologic treatments Assess individual patient needs for best drug administration device History of recent exacerbation Goals of therapy should be periodically reappraised to align with the revised plan of care AMDA-PA/LTC Guidelines 216 update. Vestbo J, et al. GOLD 216 update. 66 Items to Monitor Regularly Severity of respiratory symptoms (eg, cough, dyspnea, sputum) Sputum production/color Vital signs Pulse oximetry readings at rest and with exertion Mental status Anxiety or depression Ability to speak in full sentences without breathlessness Ability to perform ADLs independently Endurance Food intake and hydration Weight (unintended loss is a poor prognostic sign) AMDA-PA/LTC Guidelines 216 update. Vestbo J, et al. GOLD 216 update. 67 Summary COPD is associated with increased risk for morbidity and mortality, particularly following exacerbations Despite guideline recommendations for long-acting bronchodilator maintenance therapy, the vast majority of patients with COPD in LTC settings continue to receive short-acting therapies as maintenance treatment Along with appropriate treatment, long-term monitoring that includes regular symptom and functional assessments is critical for reducing the risk for future exacerbations Better transitional care coordination and site-specific COPD protocols are also necessary to prevent hospitalizations and improve COPD patient outcomes 68 21

22 Reminder Complete Session Pre- and Post-Test Complete Online Session Evaluation at End of Session **Links found in Event App 69 Thank You! Back Up 22

23 Long-term Care Settings In 214, nearly 9 million people in the US received care from approximately 67, regulated LTC services providers LTC service providers include the following: Adult day services centers Home health agencies Hospice facilities Nursing homes Residential care communities Harris-Kojetin L, et al. Vital Health Stat. 216;3(38). 72 Prevalence of COPD Among the Elderly COPD Among Adults 18 years old, % of adults Women Men years years years Over 75 years 9.7 Available at: 73 Nebulized LABA Results in Greater Lung Function vs Placebo (12 Weeks) Change in FEV 1 (ml) (Week 12) x Drug administered Arformoterol 15 µg bid Arformoterol 25 µg bid Arformoterol 5 µg qd Salmeterol 42 µg bid Placebo x x x x x x x x x x x x x x Time After Study Drug Administration (hour) x bid, twice daily; qd, once daily. Baumgartner RA, et al. Clin Ther. 27;29:

24 Reduction in Exacerbations with LAMA Therapy (UPLIFT Study) Probability of Exacerbation (%) Tashkin DP, et al. N Engl J Med. 28;359: Placebo Tiotropium 14% reduction in exacerbations and significant delay in the time to the first exacerbation (16.7 months vs 12.5 months) Hazard ratio,.86 (95% CI,.81.91) P< Month CI, confidence interval; UPLIFT, Understanding Potential Long-Term Impacts on Function with Tiotropium. 75 PDE4 Inhibition: Roflumilast Mean Rate of COPD Exacerbations Per Patient Per Year Placebo group Roflumilast group Intention to Treat Per Protocol Intention to Treat Severe exacerbations Exacerbations leading to hospital admission Roflumilast reduces exacerbations and hospital admissions in patients with severe COPD and chronic bronchitis receiving ICS/LABA therapy ± tiotropium. Martinez FJ, et al. Lancet. 215;385(9971): Combined ICS/LABA Therapy Decreases the Risk for Future Exacerbations TORCH Study Comparison HR (95% CI) P value Combination therapy vs PBO.75 (.69.81) <.1 Combination therapy vs SAL.88 (.81.95). Combination therapy vs FLU.91 (.84.99).2 SAL vs PBO.85 (.78.93) <.1 FLU vs PBO.82 (.76.89) <.1 Annual rate of exacerbation: PBO=1.13; SAL=.97; FLU=.93; SAL+FLU=.85 Combined SAL+FLU therapy was associated with a decrease in the risk for moderate or severe exacerbations vs PBO or either component alone. FLU, fluticasone propionate; HR; hazard ratio; PBO, placebo; SAL, salmeterol; TORCH, Towards arevolution in COPD Health. Calverley P, et al. N Engl J Med. 27;356:

25 Prognostic Indicators of the Need for Palliative or Hospice Care Disabling shortness of breath at rest Increased ED visits or hospitalizations Low oxygenation at rest (PaO 2 <55 mm Hg or SaO 2 <88%) Right heart failure secondary to pulmonary disease Unintentional progressive weight loss >1% in last 6 months Resting heart rate >1 beats/minute PaO 2: arterial oxygen pressure; SaO 2: arterial oxygen percent saturation. AMDA-PA/LTC Guidelines 216 update; Fox et al. JAMA.1999; 282(17): ; Maxwell et al. UNIPAC One: The Hospice/Palliative Medicine Approach to Life-limiting Illness, 3rd ed