in the Treatment of Asthma and COPD Margaret Miklich PharmD BCACP Clinical Assistant Professor 1 m argaretmiklichtempleedu I have no conflicts of interest to disclose 2 Pharmacist Objectives ID: 804136
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Slide1
Just Breathe: Clinical Updates in the Treatment of Asthma and COPD
Margaret Miklich, PharmD, BCACPClinical Assistant Professor
1
m
argaret.miklich@temple.edu
Slide2I have no conflicts of interest to disclose.2
Slide3Pharmacist ObjectivesConstruct a comprehensive asthma treatment plan consistent with current GINA guidelines.Construct a comprehensive COPD treatment plan consistent with current GOLD guidelines.
Compare and contrast drug delivery devices for inhaled asthma and COPD medications.3
Slide4Technician ObjectivesDescribe two goals of asthma treatment.Describe two goals of COPD treatment.
Differentiate between “rescue” and “controller” medications.4
Slide5Abbreviations5
GINA= Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention.
EPR= National Heart, Lung, and Blood Institute (NHLBI). National Asthma Education and Prevention Program (NAEPP). Expert Panel Report (EPR):
Guidelines
for the Diagnosis and Management of
Asthma
SABA= Short-acting beta agonist
ICS= Inhaled corticosteroid
LTRA= leukotriene receptor antagonist
LABA= long-acting beta agonist
SAMA= short-acting muscarinic antagonist
LAMA= long-acting muscarinic antagonist
COPD= chronic obstructive pulmonary disease
IgE
= immune-globulin E
IL= interleukin
GOLD= global initiative for chronic obstructive lung disease
FEV1= forced expiratory volume in one second
mMRC
= modified medical research council dyspnea scale
CAT= COPD assessment test
HFA=
hydrofluoroalkane
DPI= dry powder inhaler
Slide66
Asthma
Slide7Asthma Epidemiology
7
7.6%
18,445,000
U.S. Adults
U.S. Children
2015 National Health Interview Survey (NHIS) Data
8.4%
6,188,000
Slide8Asthma Epidemiology8
1.6 million
ED visits with asthma as primary diagnosis
3,615
Deaths with asthma as underlying cause
10.5 million
Physician office visits with asthma as primary diagnosis
https://www.cdc.gov/nchs/fastats/asthma.htm; 2012 National Ambulatory Medical Care Survey; 2010 National Hospital Discharge Survey (NHDS) datahttps://wonder.cdc.gov/
$56
billion
Cost of asthma in the U.S.
Slide9Asthma Guidelines9
1989
1
st
expert panel convened
1991
EPR-1
1993
GINA founded
1995
1
st
GINA guideline
1997
EPR-2
2002
Focused update of GINA
guideline
2002
Focused update of EPR-2
2006
GINA
g
uideline major revision2007EPR-32014GINAguideline major revisionEPR= National Heart, Lung, and Blood Institute (NHLBI). National Asthma Education and Prevention Program (NAEPP). Expert Panel Report (EPR):
Guidelines for the Diagnosis and Management of AsthmaGINA= Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. 2011EPR-3 quick-reference guide updated
Slide10Asthma Definition10
“….a heterogeneous disease, usually characterized by
chronic airway inflammation. It is defined by the history of respiratory symptoms such as wheeze, shortness of breath, chest tightness and cough
that
vary over time and in intensity
, together with
variable airflow limitation
”
www.ginasthma.org
Slide11Asthma Goals of Therapy11
Reduce
Impairment
Prevent and control symptoms (e.g. SOB, coughing
)
Reduce use of SABA for quick-relief of symptoms
Maintain near normal pulmonary function
Maintain normal activity levels
Reduce
Risk
Prevent acute exacerbations
Prevent ED visits and hospitalizations
Prevent progressive loss of lung function
Minimize adverse effects of pharmacotherapy
www.ginasthma.org
Slide12Stepwise Therapy: EPR-312
EPR-3
Slide13Stepwise Therapy- GINA 201713
www.ginasthma.org
Slide14Summary of Preferred Controllers
Step 1
Step
2
Step 3
Step 4
Step 5
Step 6
EPR-3
None
Low-dose ICS
Medium-dose ICS
-or-
Low-dose ICS
plus LABA
Medium-dose
ICS plus LABA
High-dose ICS plus LABA
-and-
consider
omalizumab
High-dose ICS plus LABA plus OCS-and-consider omalizumabGINA
Low-dose ICS plus LABAMedium or high-dose ICS plus LABAAlternative:add tiotropium
Refer for add-on treatment:omalizumab
mepolizumabreslizumabtiotropium14EPR-3; www.ginasthma.org
Slide15Stepwise Therapy- GINA 2017Before stepping up, check: Diagnosis
Adherence 15
Inhaler technique
Modifiable
risk factors
www.ginasthma.org
Stepping up is a “Therapeutic Trial”
Sustained step up (2-3 months)
Short-term step up (1-2 weeks)
Day-today adjustment
Slide16TiotropiumFDA approvals2004:
Handihaler® for COPD2014: Respimat® for COPD2015:
Respimat® for asthma in ≥ 122017:
Respimat
® for asthma in ≥6
GINA 2017 Guidelines
In Steps 4 & 5:
Add-on therapy for adults/adolescents with a history of exacerbations
16
https://
www.accessdata.fda.gov/scripts/cder/daf/index.cfm; www.ginasthma.org
Slide17New Biologic Agents: Anti-IgEOmalizumab (
Xolair)MOA: inhibits IgE binding on mast cells, limiting release of allergen inflammatory mediators$$$
Dosing: subQ
q2-4 weeks; based on weight and baseline
IgE
level
Role in Therapy
: add-on to ICS/LABA for patients (age
≥
6) with mod/
sev
allergic asthma not controlled on Step 4
BBW
: Anaphylaxis
17
Xolair
(
omalizumab
) [prescribing information]. San Francisco, CA: Genentech
Inc
; July 2016
Slide18New Biologic Agents: IL-5 AntagonistsMOA: inhibits IL-5 signaling to
↓ production and survival of eosinophils$$$18
Mepolizumab
(
Nucala
)
Reslizumab
(
Cinqair
)
SubQ
q4 weeks
Dosing
IV q4 weeks; weight based
Add-on to ICS/LABA for
patients
(age ≥ 12)
with
severe eosinophilic asthma
not controlled on Step 4
Role in Therapy
Add-on to ICS/LABA for
adults with severe eosinophilic asthma not controlled on Step 4NoneBBWAnaphylaxis
Benralizumab
: pending FDA approvalCinqair (reslizumab) [prescribing information]. Frazer, PA: Teva; March 2016Nucala (mepolizumab
) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; February 2017
Slide19In the PipelineIL-4 and IL-13 AntagonistsLebrikizumab,
Tralokinumab, Anrukinzumab, DupilumabSoluble Guanylate Cyclase (sGC
) StimulatorsRiociguat,
Cinaciguat
Sensitive Glucocorticoid Receptor Agonists and Modulators (SEGRAMs)
Syndecan-4
Calcialytics
19
https://asthma.net/living/new-exciting-asthma-treatments-horizon/
Images via Creative Commons
Slide20Assessment Question 1: PharmacistsCG is a 31yo woman with a PMH of asthma who presents to your respiratory clinic. She is not controlled on Step 3 therapy (low-dose ICS plus LABA). She needs to be stepped up to Step 4. What is an option for therapy per GINA guidelines?
Change to medium-dose ICSChange to medium-dose ICS plus LABAAdd tiotropium
to current therapyAdd reslizumab
to current therapy
20
Slide21Assessment Question 1: TechniciansWhich of the following are goals of asthma treatment? [Select all that apply]
Decrease exacerbationsIncrease rescue inhaler useDecrease symptomsIncrease lung function
21
Slide2222
COPD
Slide23COPD Epidemiology
23
6.4
%
15,700,000
U.S. Adults
Wheaton.
MMWR
. 2015.
Slide24COPD Epidemiology24
$1.05 billion
Annual cost for Medicare COPD readmissions (US)
15,694
Medicare hospitalizations for COPD as primary diagnosis (PA)
Ford.
Chest.
2013.
AHRQ Statistical Brief #196
Slide25COPD GOLD Guidelines25
1998
GOLD formed
2001
1
st
GOLD report
(
spirometric
grading)
2011
GOLD Major Revision
(ABCD multimodal grading)
2017
GOLD Major Revision
(refined ABCD grading)
GOLD
= Global Initiative for Chronic Obstructive Lung Disease
Slide26COPD Goals of Therapy26
Reduce
Symptoms
Relieve symptoms
Improve exercise tolerance
Improve health status
Reduce
Risk
Prevent
disease progression
Prevent
and treat exacerbations
Reduce mortality
GOLD 2017
Slide27COPD Definition27
“….a common, preventable and treatable disease that is characterized by
persistent respiratory symptoms
and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases”
www.ginasthma.org
Slide28Assessment of COPD: GOLD 200128
Slide29Assessment of COPD: GOLD 201129
Slide30Assessment of COPD: GOLD 201730
Slide31Treatment of COPD: GOLD 2017
GOLD GradePreferred Treatment
For Continued Symptoms or Exacerbations
A
PRN SABA
or
LABA
or
SAMA
or LAMA
Use
a
lternative class
B
LABA or LAMA
LAMA + LABA
C
LAMA
LAMA + LABA*
[or]
LABA + ICS
DLAMA + LABALAMA + LABA + ICS[or] LABA + ICS
31*preferredGOLD 2017
Slide32Assessment Question 2: PharmacistsSD is a 74 yo man who presents to your internal medicine clinic for follow up of COPD. He has GOLD Grade C (treated with LAMA). He just had another exacerbation. What is the most appropriate therapy for him now?
Remain on LAMASwitch to LABA + ICSAdd LABA to current therapy
Add LABA and ICS to current therapy
32
Slide33Assessment Question 2: TechniciansWhich of the following is a goal of COPD treatment? Decrease
exacerbationsDecrease exercise toleranceDecrease health statusAll of the above
33
Slide3434
Inhaled Drugs and
Drug-Delivery
Devices
Slide35Role of the PharmacistSafe and effective pharmacotherapyAdherenceInhaler TechniqueSelf-Management
35
Slide36Beta Agonists
Short Acting Beta Agonists (SABAs)*
Albuterol (Proventil, Ventolin,
Proair
)
HFA, DPI, Nebs,
Respiclick
PRN
Available in combo with SAMA
Levalbuterol
(
Xopenex
)
HFA, Nebs
PRN
-
Long-Acting Beta Agonists (LABAs)+
Salmeterol
(
Serevent
)++
DiskusBIDAvailable in combo with ICS
Formoterol (Performist)++NebsBIDAvailable in combo with ICS, LAMAIndacaterol (Arcapta)NeohalerQDAY-Olodaterol (Striverdi)
RespimatQDAY
Available in combo with LAMAArformoterol (Brovana)NebsBID-Vilanterol++ --ONLY available in combo with ICS, LAMA36* “Rescue” inhaler for asthma +approved in COPD; BBW for ↑ risk of asthma-related death ++approved for use in asthma ONLY in used in combination with ICS
Slide37Muscarinic Antagonist
Short Acting Muscarinic
Antagonists(SAMAs)
Ipratropium (
Atrovent
)
HFA, Nebs
PRN
Available in combo with SABA
Long-Acting Muscarinic Antagonists (LAMAs)*
Tiotropium
(Spiriva)**
Handihaler
,
Respimat
QDAY
Available in combo with LABA
Aclidinium
(
Tudorza
)
PressairBIDAvailable in combo with LABA
Umeclidinium (Incruse)ElliptaQDAYAvailable in combo with LABAGlycopyrrolate (Seebri)NeohalerBIDAvailable in combo with LABA
37
*approved in COPD; **approved in asthma
Slide38Inhaled Corticosteroids
Inhaled Corticosteroids (ICS)
Beclomethasone
(QVAR)
HFA
BID
-
Budesonide (
Pulmicort
)
Flexhaler
, Nebs
BID
Available in combo with LABA
Ciclesonide
(
Alvesco
)
HFA
BID
-
Flunisolide (Aerospan)HFABID-Fluticasone
furoate (Arnuity)ElliptaQDAYAvailable in combo with LABAFluticasone proprionate (ArmonAir, Flovent)HFA, Respiclick, DiskusBIDAvailable in combo with LABAMometasone (
Asthmanex)HFA,
TwishalerBIDAvailable in combo with LABA38
Slide39Combination Products
LABA/LAMA
Indacaterol
/
Glycopyrrolate
(
Utibron
)
Neohaler
BID
Olodaterol
/
Tiotropium
(
Stiolto
)
Respimat
QDAY
Vilanterol
/Umeclidinium (Anoro) ElliptaQDAY39
LABA/ICSBudesonide/Formoterol (Symbicort)HFABIDMometasone/Formoterol (Dulera)
HFABID
Fluticasone/Salmeterol (Advair)Diskus, HFABIDFluticasone/Vilanterol (Breo)ElliptaQDAYSABA/SAMAIpratropium/Albuterol (Combivent)HFA, NebsPRN
Slide40Delivery DevicesMetered dose inhalersHFASlow deep inhalationSpacer improves delivery
Requires priming40
Images via Creative Commons
Slide41Delivery DevicesSoft mist inhalerRespimatSlow deep inhalation
Excellent delivery to lungRequires priming
41
Image via Creative Commons
Slide42Delivery DevicesDry powder multidose inhaler
Diskus, Ellipta, Respiclick, Pressair, Twisthaler
Quick forceful inhalationMay require “activation” of next dose
42
Images via Creative Commons
Slide43Delivery DevicesDry powder capsule/piercing device inhalerHandihaler,
NeohalerQuick forceful inhalationRequires manual loading and piercing of capsule
43
Images via Creative Commons
Slide44Assessment Question 3: PharmacistsWhich of the following inhaler(s) is/are dry powder multidose inhalers? [select all that apply]
RespimatRespiclickTwisthaler
Handihaler
44
Slide45Assessment Question 3: TechniciansWhich of the following inhalers is a “rescue” medication for asthma?
Inhaled Corticosteroid (ICS)Long-Acting Muscarinic Antagonist (LAMA)Long-Acting Beta Agonist (LABA)
Short-Acting Beta Agonist (SABA)
45
Slide46References46
2015 National Health Interview Survey (NHIS) Data https://www.cdc.gov/nchs/fastats/asthma.htm2012 National Ambulatory Medical Care Survey; 2010 National Hospital Discharge Survey (NHDS) datahttps://wonder.cdc.gov/Food and Drug Administration Approved Drug Products. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
Bottrell J. New, Exciting, Asthma Treatments On The Horizon. Asthma.net. https://asthma.net/living/new-exciting-asthma-treatments-horizon/
AHRQ
Statistical Brief #
196:
Trends in Hospital Readmissions for Four High-Volume Conditions,
2009-2013. https
://www.hcup-us.ahrq.gov/reports/statbriefs/sb196-Readmissions-Trends-High-Volume-Conditions.pdf
National Asthma Education and Prevention Program (NAEPP). Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma. Clinical Practice Guidelines, National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 08-4051, prepublication 2007. Available at http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf
.
Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA).
www.ginasthma.org
Global Initiative for Chronic Obstructive Lung Disease (GOLD): Global Strategy for the Diagnosis, Management, and Prevention of COPD 2017.
www.goldcopd.org
Ford ES, Croft JB,
Mannino
DM, Wheaton AG, Zhang X, Giles WH. COPD Surveillance—United States, 1999-2011. Chest. 2013;144(1):284-305. doi:10.1378/chest.13-0809.
Slide47Just Breathe: Clinical Updates in the Treatment of Asthma and COPD
Margaret Miklich, PharmD, BCACPClinical Assistant Professor
47
m
argaret.miklich@temple.edu