8/11/16 MEDICATION THERAPIES FOR ASTHMA AND COPD: SIMILARITIES & DIFFERENCES FOR THE PRIMARY CARE NURSE PRACTITIONER

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MEDICATION THERAPIES FOR ASTHMA AND COPD: SIMILARITIES & DIFFERENCES FOR THE PRIMARY CARE NURSE PRACTITIONER Catherine Casey S. Jones, PhD, APRN, AE-C, ANP-C CATHERINE CASEY S. JONES, PHD, APRN, AE-C, ANP-C Texas Pulmonary & Critical Care Consultants, PA & Visiting Assistant Clinical Professor at Texas Woman s University in Dallas Disclosures No financial relationship with any pharmaceutical manufacturer or medical device company Objectives Explain the current guidelines for medication therapy for asthma and chronic obstructive pulmonary disease. Examine and compare the different medications for asthma and chronic obstructive pulmonary disease that are currently available in the United States. Categorize the different inhaled medications into their respective classes and how to formulate a plan for a patient with obstructive lung disease. Goals of Therapy for Asthma Strive to achieve normal lung function Absence of symptoms Normal quality of life CONTROL Goals of therapy for COPD Symptom relief Prevent disease progression Prevent and treat complications Prevent and treat exacerbations Improve or maintain health status 1

Quick Relief or Rescue Inhalers For both asthma and COPD, everyone should have a quick relief inhaler. Usually this is albuterol, but it may be ipratropium or a combination of both. For both diseases this should only be a PRN medication! Rules of Two for Asthma Monitor Use of Short Acting Beta 2 Agonists Have asthma symptoms or take a short acting beta 2 agonist (quickrelief or rescue inhaler) such as albuterol more than two times a week Awaken at night with asthma symptoms more than two times a month Refill your rescue inhaler more than two times a year Measure your peak flow at less than two times 10 (20 %) with asthma symptoms *Baylor Health Care System Use Rules of Two Only prn use Use of correct inhaler Expiration date Writing a prescription Metered Dose Inhalers 3 basic techniques: 1) Use with a spacer 2) Finger breadth method open mouth 3) Directly in mouth closed mouth method MDI with Spacer (Holding Chamber) Advantages: Coordination Increased deposition Improved particle size Reduction of side effects 2

Spacers for Financially Challenged Albuterol Metered dose inhalers: Albuterol (ProAir, Proventil and Ventolin HFA) short acting beta-2 agonist 200 doses Levalbuterol (Xopenex HFA) - short acting beta-2 agonist 200 doses RespiClick ProAir RespiClick Breath activated inhaler Powdered albuterol 200 doses Ipratropium Ipratropium (Atrovent HFA MDI) Anticholinergic with slower onset of action than albuterol Some COPD patients respond better to this medication Excellent choice for acute cough and asthmatics with acute cough PRN medication 200 doses Albuterol & Ipratropium combined (Combivent Respimat ) No longer in MDI form Individual choice/benefit from the combination form especially some COPD patients 120 doses use within 90 days One inhalation up to QID Exercise-induced Bronchospasm For patients who have normal pulmonary function but experience exerciseinduced symptoms 15-30 minutes before exercise: use albuterol If exercise-induced symptoms persist: consider adding leukotriene antagonist If pulmonary function tests are abnormal at baseline It s not just exercise-induced bronchospasm Treat according to stepwise regimen 3

Controller Medications for Asthma Once the asthmatic has been diagnosed with persistent asthma the gold standard of care is inhaled corticosteroid therapy. Prudent to begin with low dose and progress to high dose inhaled corticosteroid therapy as necessary, but this depends on the clinical situation. If the patient has a combination of asthma and COPD, the medication therapy is dictated by the asthma guidelines. Goal for asthma therapy is always the lowest dose possible to maintain good control use the Rules of Two. Efficacy of Inhaled Corticosteroids in Asthma: All Populations Over a decade of studies have demonstrated: Decrease asthma symptoms Improve lung function Reduce asthma morbidity/ mortality Less need for oral corticosteroids Lower risk of hospitalization Protection against asthma death Reduce bronchial hyperresponsiveness National Asthma Education and Prevention Program. Publication No. 07-4051. Available from: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm Metered Dose Inhalers - Corticosteroids Mometasone (Asmanex HFA) corticosteroid 100 & 200 mcg Ciclesonide (Alvesco HFA) corticosteroid 80 & 160 mcg Fluticasone (Flovent HFA) corticosteroid - 44, 110, 220 mcg Beclomethasone (QVAR HFA) corticosteroid 40 & 80 mcg Flunisolide Flunisolide (Aerospan HFA MDI) 80 mcg Inhaled corticosteroid Built in spacer Corticosteroids in Other Devices Budesonide (Pulmicort Flexhaler) ONLY category B for pregnancy 90 mcg (60 doses) or 180 mcg (120 doses) Counter on side count down by tens Mometasone furoate (Asmanex Twisthaler) 30, 60 or 120 doses - 110 or 220 mcg 4

Corticosteroids in Other Devices Inhaled Corticosteroids & Oral Thrush Fluticasone propionate (Flovent Diskus) 50, 100, or 250 mcg dosage Fluticasone furoate (Arnuity Ellipta) 100 & 200 mcg Common occurrence especially in elderly & patients with severe disease Exacerbated with additional use of antibiotics and/or oral corticosteroids Have patients use alcohol containing mouthwash & rinse after each use Pediatric patients usually rinse with water and spit Inhaled corticosteroids & COPD Treatment with inhaled corticosteroids if frequent exacerbations occur severe to very severe obstruction Opposite of asthma guidelines! Inhaled corticosteroids have no direct effect on mortality or rate of decline of FEV 1 and increase the risk of pneumonia FLAME Study Indacaterol & glycopyrronium versus fluticasone/salmeterol - decreased exacerbations by 11 %, longer to first exacerbation & increased health status Long Acting Bronchodilators Two classes : Beta-2 agonists (LABA) Anticholinergics (muscarinic antagonists) For asthma first add Beta-2 agonist (always with inhaled ICS, never LABA alone) For COPD typically begin with an anticholinergic Long Acting Beta 2 Agonists for Asthma Black box warning Do NOT use for monotherapy Do NOT use unless ICS alone does not control asthma Use as LABA/ICS combination to avoid inadvertently using LABA alone Therapy: Asthma vs. COPD COPD Asthma Inhaled Corticosteroid Severity Group C & D Albuterol > 2x/week Used Alone No Yes Lo ng Acting Beta -2 Agonist Severity Group B to D Step 3-6 Used Alone Yes No 5

Long Acting Beta-2 Agonists Salmeterol (Serevent Diskus) One puff BID Indacaterol (Arcapta Neohaler) Inhale one capsule once a day Olodaterol (Striverdi Respimat) Two puffs once a day Combination MDIs Fluticasone (inhaled corticosteroid) & salmeterol (long acting beta-2 agonist) - (Advair) Mometasone (inhaled corticosteroid) & formoterol (long acting beta-2 agonist) (Dulera) - 100/5 mcg or 200/5 mcg Budesonide (inhaled corticosteroid) & formoterol (long acting beta-2 agonist) (Symbicort) - 80/4.5 mcg or 160/4.5 mcg Fluticasone & Salmeterol Combination Diskus 1 inhalation BID 100/50 250/50 500/50 HFA MDI 2 inhalations BID 45/21 115/21 230/21 Long Acting Anticholinergics Tiotropium (Spiriva) Two forms of delivery: HandiHaler & Respimat HandiHaler inhale one capsule daily Respimat inhale two puffs once a day Decreases exacerbations & hospitalizations Aclidinium bromide (Tudorza Pressair) One puff twice a day Umeclidinium (Incruse Ellipta) - 62.5 mg COPD only Glycopyrrolate (Seebri Neohaler) Long Acting Anticholinergics & Asthma Several new studies showing benefit but Does not reduce hospitalizations Does not improve quality of life Use step like process: ICS, LABA, etc. Save anticholinergics for later First approved for asthma: Spiriva Respimat Prescriber s Letter: 12/2015, Volume 22. Combination Inhalers Umeclidinium 62.5 mg and vilanterol 25 mcg anticholinergic and ultra long acting beta-2 agonist - (Anoro Ellipta) - Indicated for COPD only Fluticasone furoate 100 or 200 mcg & vilanterol 25 mcg - corticosteroid & ultra long acting beta-2 agonist (Breo Ellipta) COPD & Asthma ( age 18) 100 mcg dose for COPD Tiotropium & olodaterol anticholinergic & long acting beta-2 agonist (Stiolto Respimat) - COPD 6

Combination Inhalers Indacaterol (long acting beta-2 agonist) & glycopyrrolate (anticholinergic) (Utibron Neohaler) inhale one capsule twice a day COPD indication only Formoterol (long acting beta-2 agonist) & glycopyrrolate (anticholinergic) (Bevespi Aerosphere MDI) Two puffs BID Compliance with Inhalers Proper technique! Confusion about need for multiple inhalers Hospital versus out-patient therapy Combination therapy when possible Daily maintenance inhaler versus rescue inhaler High cost of all inhalers EDUCATE the patient Nebulizer Therapy Proven that inhaled short acting albuterol in a MDI is just as effective! Medicare Part B for DME and D for medications but who is really paying? Need to be cleaned frequently rarely performed Possible cause of superinfections Are medications in date? Save for end stage COPD & asthma Nebulized Medications Albuterol 0.083 % - 2.5 mg/3ml Ipratropium 500 mcg Combination of albuterol & ipratropium (DuoNeb) 3 ml Formoterol (Perforomist) - 20 mcg BID Arformoterol (Brovana) - 15 mcg BID Budesonide (Pulmicort Respules) - 0.25, 0.5, & 1 mg/2ml usually a BID dosage Leukotriene Receptor Antagonists Time of dosing - irrelevant Triad asthma Obese asthmatics Asthmatics who smoke Asthmatics with elevated IgE Effective in ~ 15%; if no response is seen, discontinue LTRA Not indicated for COPD Leukotriene Receptor Antagonists Zafirlukast (Accolate) - 20 mg BID - 1 hour before or 2 hours after meals Montelukast (Singular) - 10 mg daily Zileuton (Zyflo) 600 mg QID or ER 1200 mg BID Monitor hepatic transaminases (ALT) prior to initiation & during therapy 7

Omalizumab Therapy (Xolair) - monoclonal antibody therapy for asthma Subcutaneous dose based on body weight Pretreatment total IgE serum levels (30 to 700 IU/mL) Age 12 or above Minimum of 12 weeks of therapy & usually at least 3-6 months Watch for severe hypersensitivity reaction or anaphylaxis Fever, arthralgias or rash report and discontinue therapy Mepolizumab Therapy (Nucala) - Monoclonal antibody to IL-5 (a pro-eosinophilic cytokine) Reduce exacerbations in severe asthma who have blood eosinophil counts of 150/microL or greater Age 12 or older & have eosinophilic phenotype Subcutaneous injection & may be given IV Herpes zoster infections have occurred in small number of patients; insure immunized against shingles before using Decrease exacerbations and improve quality of life Reslizumab Therapy (Cinqair) Humanized anti-interleukin-5 monoclonal antibody for eosinophilic asthma Ages 12-75 years Improve lung function, control asthma symptoms & improved quality of life Eosinophils 400 cells/µl Oral Agents for COPD Roflumilast (Daliresp) - phosphodiesterase-4 enzyme inhibitor 500 mcg once a day Watch for weight loss & nausea Theophylline may use once or twice a day Cheap, add on therapy Use low dosage, check serum level in 7 14 days, goal ~ 10 µg/ml Multiple possible drug interactions, especially quinolones Treatment of Exacerbations of COPD Prednisone 40 mg daily for five days versus 14 days five day course not inferior with regards to re-exacerbations during next six months. No differences in recovery of lung function or disease related symptoms Leuppi, Schuetz, Bingisser, et al. Short-term vs conventional glucocorticoid therapy in acute exacerbations of COPD: JAMA 2013; 309:2223-2231. Therapy for Asthma & COPD Influenza vaccination high dose if age 65 or older Consider Tdap vaccination one booster for pertussis otherwise Td Pneumococcal 23 vaccination Number needed to treat: 20,000 to avoid one infection 50,000 to avoid death 8

Pneumococcal vaccines Prevnar 13 works better than Pneumovax 23 to induce an immune response in older adults Pneumovax 23 covers 11 serotypes that aren t in Prevnar 13 Prevnar 13 has one serotype that isn t in Pneumovax 23 Medicare will pay for both vaccines Pneumococcal vaccines All those 65 and older need BOTH Pneumovax 23 and Prevnar 13 Pneumococcal vaccine status FIRST give THEN give None/unknown Prevnar 13 Pneumovax 23 12 months later Pneumovax 23 given after 65 Pneumovax 23 before 65 Prevnar 13-12 N/A months or later after Pneumovax 23 Prevnar 13 65 or older & one year or more after Pneumovax 23 Pneumovax 23-12 months after Prevnar 13 & 5 years after Pneumovax 23 Medication Abbreviations SABA = Short-acting beta-2 agonist LABA = Long-acting beta-2 agonist SAMA = Short-acting muscarinic antagonist (anticholinergic) LAMA = Long-acting muscarinic antagonist (anticholinergic) ICS = Inhaled corticosteroid PDE-4 inh = Phosphodiesterase-4 inhibitor Intermittent Asthma Step 1 SABA PRN Persistent Asthma: Daily Medication Co n su lt with asth ma sp ecialist if step 4 care o r hig her is req uired. Consider consultation at step 3. Step2 Low-dose ICS Alternative: Cro mo ly n, LTRA, Ned o cro mil, o r Theophylline Step 4 Medium-dose ICS + LABA Alternative: Medium-dose ICS+eith er LTRA, Theophylline, or Zileuton Step 5 Hig h -dose ICS + LABA AND Co n sid er Omalizu mab fo r p atien ts wh o h av e allerg ies Step 6 Hig h -dose ICS + LABA + oral co rtico stero id AND Co n sid er Each step: Patient education,environmental control,and management of comorbidities. Steps 2-4: Consider subcutaneous allergen immunotherapy for patients who have allergic asthma * Qu ick -Relief Medication for AllPatients Step 3 Low dose ICS + LABA OR med iu m- dose ICS Alternative: low-dose ICS + either LTRA, Theophylline, or Zileuton Omalizu mab fo r p atien ts wh o h av e allerg ies SABA as needed for symptoms.intensity of treatmentdepends on severity of symptoms: up to 3 treatments at 20-minute intervals as needed. Short course of oral systemic corticosteroids may be needed Cau tio n : Increasing use of SABA or use >2 days a week for sy mp to m relief (no tpreven tion of EIB) g enerally ind icates inadequate control and the need to step up treatment. Step up if needed (first, ch eck ad h eren ce, en v iro n men tal co n tro l, an d co mo rb id co n d itio n s) Assess co n tro l Step down if possible (an d asth ma is well co n trolled at least 3 mo n th s) GOLD GROUPINGS GROUP A: Low risk, less symptoms GOLD 1-Mild or 2-Moderate airflow limitation 0-1 exacerbations/year mmrc grade 0-1 CAT score < 10 GROUP B: Low risk, more symptoms GOLD 1-Mild or 2-Moderate airflow limitation 0-1 exacerbations/year mmrc grade 2 CAT score 10 Stepwise Approach for Managing Asthma in Youths 12 Years of Age and Adults 9

GOLD GROUPINGS GROUP C: High risk, less symptoms GOLD 3-Severe or 4-Very Severe airflow limitation 2 exacerbations/year mmrc grade 0-1 CAT score < 10 GROUP D: High risk, more symptoms GOLD 3-Severe or 4-Very Severe airflow limitation 2 exacerbations/year mmrc grade 2 CAT score 10 Pharmacologic Management of COPD Patient Group A First Choice Second Choice Alternative Choice SABA prn or SAMA prn LAMA or LABA, or SABA & SAMA Theophylline B LAMA or LABA LAMA & LABA SABA &/or SAMA; Theophylline C ICS/LABA or LAMA LAMA & LABA PDE-4-inh or SABA &/or SAMA; Theophylline D ICS/LABA or LAMA ICS & LAMA or ICS/LABA Carbocysteine; & LAMA or SABA &/or SAMA ICS/LABA & PDE-4 inh or LAMA & LABA or LAMA & PDE-4 inh GOLD Guidelines -2015 References http://use-inhalers.com/ caseyjonesnp@gmail.com 10