Download 2016 MPhA MTM Symposium

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