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2016 MPhA MTM Symposium - New Drug Update Heidi Le, PharmD & Lara Kerwin, PharmD Pharmaceutical Care Leadership Residents University of Minnesota College of Pharmacy Objectives: 1. Compare 2 new drugs coming to market with current therapy. 2. Evaluate findings of one clinical research publication and discuss how it applies to current practice. Drug/Medication name Unmeclidinium/vilanterol (Anoro Ellipta®) Mechanism of Action Bronchodilation through inhibitory effects at airway smooth muscle M3 receptor plus local bronchodilatory effects through rapid- and long-acting β2-adrenergic agonist Potent anti-inflammatory effects plus local bronchodilatory effects through rapid- and longacting β2-adrenergic agonist Indication(s) COPD Asthma, COPD Dosing DPI: 1 oral inhalation of umeclidinium bromide 62.5 mcg/vilanterol trifenatate 25 mcg once daily; MAX 1 dose every 24 hours Monitoring Efficacy: improvement or maintenance of respiratory function, inhaler technique Adverse Effects Indicaterol/glycopyrrolate (Utibron Neohaler®) DPI: 1 capsule (indacaterol 27.5 mcg/glycopyrrolate 15.6 mcg) via oral inhalation twice daily Fluticasone-Salmeterol (Advair®)* DPI: 1 oral inhalation of fluticasone 250 mcg/salmeterol 50 mcg twice daily Safety: s/sx acute narrow-angle glaucoma, urinary retention Safety: bone mineral density, oral candidiasis - Diarrhea (2%) - Pharyngitis (2%) - Pain in limb (2%) - Lower RTI (1%) - Chest pain (1%) - Nasopharyngitis (4.1%) - Headache (≥ 2%) - Diarrhea (≥ 2%) - GERD (≥ 2%) - Pneumonia (≥ 2%) - Hypertension (2%) - Chest pain (< 1%) - Headache (9-21%) - Oral candidiasis (10%) - Upper RTI (> 5%) - Pneumonia (7-16%) - Tachycardia (1-3%) $4500/year $4000/year $5000/year Clinical Considerations Cost (approximate) *SOC = Standard of care, DPI = dry-powder inhaler 4 ≥2 3 ≥ 1 (hospitalization) 2 1 (not leading to hospitalization) 1 CAT < 10 CAT ≥ 10 0 Risk (Exacerbation History) GOLD 1: Mild FEV1 ≥ 80% pred GOLD 2: Moderate 50% ≤ FEV1 < 80% pred GOLD 3: Severe 30% FEV1 < 50% pred GOLD 4: Very Severe FEV1 < 30% pred Risk (GOLD Classification of Airflow Limitation) GOLD COPD Classification Symptoms mMRC 0-1 mMRC ≥ 2 Breathlessness 2016 GOLD recommendations: (Updated January 2016) GOLD Category First Line Agent Alternative Agent LAMA or LABA or A SAMA or SABA prn SABA and SAMA B LAMA or LABA LAMA and LABA C ICS + LABA or LAMA D ICS + LABA and/or LAMA LAMA and LABA or LAMA and PDE4-i or LABA and PDE4-i ICS + LABA and LAMA or ICS+LABA and PDE4-i or LAMA and LABA or LAMA and PDE4-i Other Possible Agents Theophylline SABA and/or SAMA Theophylline SABA and/or SAMA Theophylline Carbocysteine N-acetylcysteine SABA and/or SAMA Theophylline Evidence: FLAME was a multicenter, double-blind, randomized, double-dummy, non-inferiority trial (Published May 2016) Patient Population 3362 patients ≥40 years of age, COPD with a grade of 2 or higher*, post-bronchodilator FEV1 of at least 2560%, FEV1/FVC <0.70, and a history of at least one COPD exacerbation during the previous year Intervention Indacaterol (110 mcg) plus glycopyrronium (50 mcg) once daily (n=1680) Comparator Salmeterol (50 mcg) plus fluticasone (500 mcg) twice daily (n=1682) Outcome Primary Outcome: Inferiority comparison of annual rate of all COPD exacerbations of any severity. Secondary Outcome: If non-inferior, superiority comparison of annual rate of all COPD exacerbations of any severity. Results Primary Outcome: • Annual rate of all COPD exacerbations: 3.59 vs. 4.03 [P=0.003] in the intervention vs. comparator group (11% lower rate). Secondary Outcome: • Time to first exacerbation of any severity: 71 days vs. 51 days [P<0.001] (16% lower risk). • Annual rate of moderate or severe COPD exacerbations: 0.9 vs. 1.19 [P<0.001] (17% lower rate). • Time to first moderate or severe exacerbation: 128 days vs. 87 days [P<0.001] (22% lower risk). A 1-week screening period was followed by a 4-week run-in period, during which all patients were treated with inhaled tiotropium at a dose of 18 mcg once daily. After the run-in period, tiotropium was discontinued, and the patients were randomly assigned, in a 1:1 ratio. Safety: Both groups incidence of death was 1.4% (n=24) commonly due to respiratory and cardiovascular causes. Pneumonia rates were 3.2% (n=53) vs. 4.8% (n=80) in the intervention vs. comparator group, respectively [P=0.02]. *Graded using the modified Medical Research Council scale FEV1 = forced expiratory volume in 1 second; FVC = forced vital capacity