copd changes to guidelines and new inhalers dr...
TRANSCRIPT
1/12/2017
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Dr. Kajua B. Lor, Pharm.D., BCACPAssociate ProfessorMedical College of WisconsinSchool of Pharmacy [email protected]
COPD: Update on Guidelines and Making Sense of New Inhalers
@kajualorpharmd
DISCLOSURE STATEMENT
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• Kajua B. Lor, Pharm.D. • Investigator has no conflict of interest to disclose. • Proprietary information or results of ongoing research may
be subject to different interpretations• Speaker’s presentation of this slide indicates agreement to
abide by the non commercialism guidelines provided in the CE Requirements page
LEARNING OBJECTIVES
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• Given a patient case, evaluate and apply the 2017 GOLD guidelines for classification on pharmacological management
• Describe the role of bronchodilators in the management of stable COPD.
• Determine when inhaled corticosteroids may be appropriate for use in stable COPD
• Understand differences between old and new inhalers used for COPD
OUTLINE
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2017 GOLD Guidelines• Assessment• Combination
inhalers
Making Sense of New Inhalers• Dry Powder Inhalers• Soft-mist inhalers
DEFINITION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) • Chronic obstructive pulmonary disease (COPD) is “a disease
state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually both progressive and associated with an enhanced inflammatory response of the lungs to noxious particles or gases.”
• Often encompasses CHRONIC BRONCHITIS and/or EMPHYSEMA
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NHLBI/WHO. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2017.
EPIDEMIOLOGY OF COPD
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15 million people in the US 12 million remain undiagnosed
1.5 million ED visits per year
$42.6 billion direct and indirect cost in 2007
3rdleading cause of death
Primary cause: SMOKING
CDC COPD Fact Sheet. Chronic Obstructive Pulmonary Disease. https://www.cdc.gov/copd/index.html
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2017 GOLD GUIDELINES
• Global Initiative for Chronic Obstructive Lung Disease (GOLD)
• National Heart, Lung and Blood Institute (NHLBI)
• World Health Organization (WHO)
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COPD - GOALS OF THERAPY
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Reduce Symptoms• Relieve symptoms• Improve exercise
intolerance• Improve health status
Reduce Risk• Prevent disease
progression• Prevent and treat
exacerbations• Reduce mortality
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I: Mild II: Moderate III: Severe IV: Very Severe
Characteristics FEV1/FVC< 70%
FEV1≥ 80% predicted
FEV1/FVC <70%
50%≤ FEV1<80% predicted
FEV1/FVC <70%
30%≤ FEV1<50% predicted
FEV1/FVC <70%
FEV1<30% predicted OR (FEV1
<50% + chronic respiratory failure)
NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease. 2007.
‘OLD’ TREATMENT ALGORITHM OF COPD
• Active reduction of risk factors • Annual influenza vaccine• Add short-acting bronchodilator PRN
• Add regular treatment with one or more long-acting bronchodilators
• Add pulmonary rehabilitation
“Regular” refers to scheduled basis
• Add ICS if repeated exacerbations
• Add long-term O2
if chronic respiratoryfailure• Consider surgical Tx
2011 ASSESSMENT OF COPD
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Symptoms • COPD Assessment Tool
(CAT)• Modified British Medical
Research Council (mMRC)
Degree of Airflow Limitation (using
Spirometry)
Risk of Exacerbations Comorbidities
NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease. 2011.
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2011 COMBINED ASSESSMENT
Patient CharacteristicSpirometric
ClassificationExacerbations
per yearmMRC CAT
ALow Risk
Less SymptomsGOLD 1-2 ≤ 1 0 – 1 < 10
BLow Risk
More symptoms
GOLD 1-2 ≤ 1 ≥ 2 ≥ 10
CHigh Risk
Less symptomsGOLD 3-4 ≥ 2 0-1 < 10
DHigh Risk
More symptoms
GOLD 3-4 ≥ 2 ≥ 2 ≥ 10
When assessing risk, choose the HIGHEST risk according to GOLD grade or exacerbation history.
NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease. 2015.
2017 ASSESSMENT
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Diagnosis of COPD
(FEV1/FVC<0.7)
Assessment of Airflow Limitation (Spirometry)
Assessment of symptoms/risk of exacerbations • Exacerbation History• Modified British Medical Research Council (mMRC)• COPD Assessment Tool (CAT)
Comorbidities
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13NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease. 2017.
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ASSESSMENT OF COPD: SPIROMETRYClassification Characteristics
*All patients have FEV1/FVC<70%
GOLD 1: Mild FEV1≥ 80% predicted
GOLD 2: Moderate 50%≤ FEV1<80% predicted
GOLD 3: Severe 30%≤ FEV1<50% predicted
GOLD 4: Very Severe FEV1<30% predicted
NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease. 2017.
*Note: FEV1 = based on post-bronchodilator FEV1
ASSESSMENT OF COPD: SYMPTOMS• Modified British Medical Research Council (mMRC) – dyspnea
http://copd.about.com/od/copdbasics/a/MMRCdyspneascale.htm
• Score 0 – 1 = Less Symptoms
• COPD Assessment Tool (CAT): http://www.catestonline.org/english/indexEN.htm
• Score <10 = Less Symptoms
• Clinical COPD Questionnaire (CCQ) • http://www.ccq.nl
15NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease. 2015.
ASSESSMENT OF COPD: EXACERBATION HISTORY • History of Exacerbation
• Definition: “acute worsening of the patient’s respiratory symptoms that results in additional therapy”
• Classification of Exacerbation • Mild (treated with short-acting bronchodilators) • Moderate (+ antibiotics and/or oral corticosteroids) • Severe (all of the above + hospitalization or ER visit)
• 0 or 1 (not leading to hospital admission) - Group A or B
• >=2 or >=1 leading to hospital admission - Group C or D
16NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease. 2017.
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DOROTHY WHITE
CASE
DW is a 61 yo female with SOB and DOE. She smoked 1 ppd for 37 yrs, but quit 10 yrs ago. Has a persistent cough that won’t go away. Had no exacerbations in the past year.mMRC score = 1. CAT = 18.
Pre-Albuterol Post-AlbuterolFEV1 (L) 2.00 L
26% predicted
2.10 L
28% predicted
FEV1/FVC% 55% 57%
FEF25-75% (L/sec) 0.75
31% predicted
0.98
40% predicted
Case• What is this patient’s GOLD stage?
• According to the 2017 guidelines, to which GOLD patient group would DW belong to?
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CASE
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19NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease. 2017.
COMPONENTS OF GOLD COPD MANAGEMENT
1. Reduce risk factors
2. Assess and Monitor Disease - Spirometry, Risk of Exacerbation, Symptoms + Comorbidities
3. Manage stable COPD- Non-pharmacologic- Pharmacologic
4. Manage acute exacerbations
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‘OLD’ 2011 GOLD GUIDELINESPatient group
Recommended First Choice Alternative ChoiceOther Possible
Treatments
ASA anticholinergic prn
OR
SABA prn
LA anticholinergic OR
LABAOR
SABA + SA anticholinergic
Theophylline
BLA anticholinergic
OR
LABALA anticholinergic + LABA
SABA and/or SA anticholinergic
Theophylline
CICS + LABA
OR
LA anticholinergic
LA anticholinergic + LABA OR
LA anticholinergic + PDE-4 Inhibitor OR
LABA + PDE-4 Inhibitor
SABA and/or SA anticholinergic
Theophylline
DICS + LABA
and/orLA anticholinergic
ICS + LABA + LA anticholinergicOR
ICS + LABA + PDE-4 InhibitorOR
LA anticholinergic + LABA OR
LA anticholinergic + PDE-4 Inhibitor
Carbocysteine
SABA and/or SA anticholinergic
Theophylline
NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease. 2015.
2017 PHARMACOLOGIC TREATMENT Patient Group
Preferred treatment Escalation/de-escalation strategies
A Bronchodilator - Evaluate effect and continue, stop or try alternative class of bronchodilators if needed
B Long-acting bronchodilator (LABA or LA anticholinergic)
- If persistent symptoms combo LA anticholinergic + LABA
C LA anticholinergic monotherapy
- If further exacerbations combo LA anticholinergic + LABA
D LA anticholinergic + LABA - If further exacerbations triple therapy LA anticholinergic + LABA+ ICS
- Consider roflumilast (if FEV1<50% predicted and pt has chronic bronchitis)
- Consider macrolide (in former smokers)
22NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease. 2017.
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DOROTHY WHITE
CASE
DW is a 61 yo female with SOB and DOE. She smoked 1 ppd for 37 yrs, but quit 10 yrs ago. Has a persistent cough that won’t go away. Had no exacerbations in the past year.mMRC score = 1. CAT = 18. Pt has Humana insurance.
Current medications: • Albuterol (Proventil®) 90 mcg/hr 1 puff q 4 - 6 hours as
needed for shortness of breath • Tiotropium (Spiriva Respimat) 2.5 mcg/actuation inhale 2
puffs once a day 24
What is the best recommendation for DW?
CASE
A) Start indacaterol (Arcapta Neohaler*) B) Start mometasone and formoterol (Dulera*)C) Start roflumilast D) Stop tiotropium. Start combination tiotropium
and olodaterol (Stiolto Respimat*)
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SUMMARY OF 2017 GOLD GUIDELINES• Revised assessment
• Spirometry – GOLD Grade 1 – 4 • ABCD groups are based on…
• History of Exacerbations• Symptom Control
• Long acting bronchodilators are preferred over short acting agents except for patients with only occasional dyspnea
• Escalation and de-escalation strategies have been added
25NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease. 2017.
OUTLINE
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2017 GOLD Guidelines• Assessment• Combination
inhalers
Making Sense of New Inhalers• Dry Powder Inhalers• Soft-mist inhalers
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PHARMACOLOGIC TREATMENT• Bronchodilators
• Beta-2 Agonists• Short-acting (SABA)
• albuterol (Ventolin, Proventil, Proair), levalbuterol (Xopenex)• Long-acting (LABA)
• salmeterol (Serevent), formoterol (Foradil, Peferomist)***, arformoterol (Brovana), indacaterol (Arcapta), Olodaterol (Striverdi)
• Anticholinergics• Short-acting: ipratropium (Atrovent)• Long-acting: tiotropium (Spiriva), aclidinium (Tudorza Pressair), umeclidinium (Incruse Elipta),
glycopyrollate (Seebri Neohaler) • Combinations
• SABA + Short-acting anticholinergic: albuterol/ipratropium (Combivent Respimat, Duoneb),• long-acting anticholinergic + LABA: Umeclidinium/Vilanterol (Anoro Elipta),
Tiotropium/Olodaterol (Stiolto), glycopyrollate/indacaterol (Utibron Neohaler) • Theophylline (Theo-24, Uniphyl, Slo-bid, Theo-Dur, etc.)
• Corticosteroids• Inhaled (ICS)
• beclomethasone (Qvar), budesonide (Pulmicort), ciclesonide (Alvesco), fluticasone (Flovent, Arnuity Elipta), mometasone (Asmanex), Combinations (ICS + LABA)
• Combination ICS + LABA • Fluticasone/salmeterol (Advair), budesonide/formoterol (Symbicort), mometasone/formoterol
(Dulera), fluticasone/Vilanterol (Breo Ellipta), • Phosphodiesterase-4 inhibitors: Roflumilast (Daliresp)• Long-Term Oxygen Therapy 28
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COPD
Bronchodilators
Short-acting
Short-acting beta agonists
Short-acting anticholinergics
Long-acting
long-acting beta agonists (LABA)
long-acting anticholinergics
aka LAMA
Combinations
LAMA/LABA LABA/ICS
Others
Roflumilast Long term oxygen
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PHARMACOLOGICAL MANAGEMENT OF COPD• Bronchodilators are central to symptom management in COPD• Inhaled bronchodilators are preferred over oral bronchodilators• Short-acting bronchodilators are given PRN – do not give on a regular basis
• Albuterol or ipratropium can be used as “quick-relievers”
• Combination of short-acting bronchodilators are superior compared to either medication alone in improving FEV1 and symptoms
• Combining bronchodilators (LABA/LAMA) may improve efficacy and decrease side effects
• LABA monotherapy is seen in COPD • Inhaled corticosteroids are used in combination and recommended for
treatment in Group C or D
NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease. 2017.
TYPES OF INHALERS
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Metered Dose Inhalers (HFA)
Examples: albuterol, beclomethasone,
albuterol/salmeterol, fluticasone/salmeterol
Dry Powder Inhalers
Diskus
Ellipta
Pressair
Capsules
Soft Mist Inhalers
Respimat
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METERED DOSE INHALERS • Examples: albuterol, beclomethasone, albuterol/salmeterol,
fluticasone/salmeterol, ipratropium
• Clean at least once a week, check when empty if it doesn’t have a counter
• Spacers may help
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METERED DOSE INHALERS
1 • Prime 3 – 4 times
2 • Shake
3 • Exhale
4 • Inhale slow and deep
5 • Hold breath
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DRY POWDER INHALERS • Examples: salmeterol, salmeterol/fluticasone, aclidinium, fluticasone/valenterol,
indacaterol
• Breath activated
• Dry powder inhalers with internal blister packs should be discarded 6 weeks after opening
Diskus Ellipta
DRY POWDER INHALERS (Cont’d)
36NeohalerPressair
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DRY POWDER INHALERS
1 • Hold inhaler in correct position
2• Exhale away from inhaler
3 • Inhale fast and deep
4 • Hold breath
SOFT MIST INHALER - RESPIMAT
• Some say the respimat is the optimal delivery system
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SOFT MIST INHALER - RESPIMAT
1 • Prime at least 4 times
2 • Exhale away from inhaler
3 • Inhale slow and deep
4 • Hold breath
NEW INHALERS
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2014Incruse Ellipta* (umeclidinium) LAMA
Tudorza Pressair* (aclidinium) LAMA
Striverdi Respimat* (olodaterol) LABA
Anoro Ellipta* (umeclidium/vilanterol) LAMA/LABA
2015Seebri Neohaler® (glycopyrrolate) LAMA
Utibron Neohaler® (glycopyrrolate/indacaterol)
LAMA/LABA
Stiolto Respimat* (tiotropium/olodaterol)
LAMA/LABA
NEW INHALERS• 2015 Inhalers: Seebri Neohaler* glycopyrrolate and Utibron Neohaler*
glycopyrrolate/indacaterol • Contain long-acting anticholinergic glycopyrrolate
• Recall other long-acting anticholinergics - tiotropium, aclidinium –Tudorza Pressair*, umeclidinium – Incruse Ellipta*
• Combination long-acting anticholinergic and LABA –umeclidium/vilanterol – Anoro* or tiotropium/olodaterol – Stiolto*
• Advantage • Similar lung function and side effect profile as tiotropium
• Disadvantage• Used BID (Seebri* and Utibron*) vs qday (Anoro* and Stiolto*) • Medication access
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MEDICATION ACCESS INHALER WI MEDICAID UNITED (INDIVIDUAL
PLANS VARY) HUMANA
Incruse Ellipta* (umeclidium) LAMATudorza Pressair* (aclidinium) LAMASeebri Neohaler® (glycopyrrolate) LAMA
Not Preferred –preferred LAMA is Spiriva
Not coveredPreferred LAMA is Spiriva Respimat/handihaler
Not covered - Preferred LAMA is Spiriva Respimat/handihaler
Striverdi Respimat* (olodaterol) LABA Not Preferred -Preferred LABA is Serevent
Not covered – preferredLABA is Serevent Diskus
Not covered - Preferred LABA is Arcapta Neohaler
Anoro Ellipta* (umeclidium/vilanterol) LAMA/LABA
Not Preferred – no combo LAMA/LABA covered
Use separate agents Spririva + Serevent
Tier 1, QL Not covered - no combo LAMA/LABA covered
Use separate agents Spririva + Arcapta Neohaler
Utibron Neohaler® (glycopyrrolate/indacaterol) LAMA/LABA
Not covered – preferred is Anoro Ellipta or StioltoRespimat
Stiolto Respimat* (tiotropium/olodaterol)LAMA/LABA
Tier 1, QL
42*As of 1/9/2017
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INHALER SUMMARY
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Metered Dose Inhalers (HFA)
Examples: albuterol, beclomethasone,
albuterol/salmeterol, fluticasone/salmeterol
Dry Powder Inhalers
Diskus
Ellipta
Pressair
Capsules
Soft Mist Inhalers
Respimat
1. Which inhalers require priming? 2. Which inhaler type is inhaled slow
and deep?
WHAT QUESTIONS DO YOU HAVE?
@kajualorpharmd
REFERENCES Magnussen H, et al. Withdrawal of Inhaled Glucocorticoids and Exacerbations of Chronic Obstructive
Pulmonary Disease. New Engl J Med 2014;371:1285-1294.
NHLBI/WHO. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2017.
Nannini LJ, Poole P, Milan SJ, Kesterton A. Combined corticosteroid and long-acting beta(2)-agonist in one inhaler versus inhaled corticosteroids alone for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2013;8:CD006826.
Calverley PM, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. Vol 356. United States: 2007 Massachusetts Medical Society.; 2007:775-789.
Kew KM, Seniukovich A. Inhaled steroids and risk of pneumonia for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2014; Mar 10;3:CD010115.
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