COPD Changes to Guidelines and New Inhalers Dr Lorocpe.mcw.edu/sites/ocpe.mcw.edu/files/users/61/COPD Changes to... · COPD: Update on Guidelines and Making Sense of New ... NHLBI/WHO

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


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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.


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


*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


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


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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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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


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


Theophylline


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)


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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


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


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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COPD Changes to Guidelines and New Inhalers Dr Lorocpe.mcw.edu/sites/ocpe.mcw.edu/files/users/61/COPD Changes to... · COPD: Update on Guidelines and Making Sense of New ... NHLBI/WHO

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