horne copd update 2016 4.15.16 - new mexico society of ...nmshp.org/resources/documents/2016 spring...

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Take My Breath Away COPD Update

Juliann Horne, PharmD, PhC, BCACP [email protected]

April 16, 2016

Take My Breath Away COPD Update

Juliann Horne, PharmD, PhC, BCACP

[email protected]

April 16, 2016

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Conflicts of Interest •  Nothing to disclose

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Learning ObjecLves – Pharmacists •  Describe signs and symptoms and classificaLon of chronic

obstrucLve pulmonary disease (COPD).

•  Explain the role of pharmacotherapy for COPD.

•  Compare and contrast recently approved pharmacotherapeuLc agents and inhaler devices for the treatment of COPD.

•  Explain appropriate use of recently approved inhaler devices.

Learning ObjecLves – Technicians

•  List signs and symptoms of COPD.

•  List treatments and inhaler devices for COPD.

•  Explain the role of pharmacotherapy for COPD.

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Outline •  Background •  Diagnosis & Assessment •  Treatment

o  Non-‐pharmacological o  New evidence in pharmacotherapy

•  Devices & AdministraLon

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Epidemiology •  3rd leading cause of death in the US •  12.7 million US adults esLmated to have COPD (2011) o  Largely underesLmated o  ~24 million U.S. adults have evidence of impaired lung funcLon o  Slightly more common in women than men

•  About 80% of cases due to cigare1e smoking •  Financial burden (US)

o  EsLmated cost: $49.9 billion (direct and indirect)

www.lung.org

COPD GOLD Guidelines 2016

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Diagnosis and Assessment

COPD Symptoms (Indicators to Consider a COPD Diagnosis)

•  Over 40 years of age (generally) •  Dyspnea

�  Progressive �  Persistent �  Worse with exercise

•  Chronic cough •  Chronic sputum producLon •  History of exposure to risk factors •  Family history of COPD

Not diagnosLc but increases probability

of COPD

Perform spirometry in paLents > 40 with any other indicators

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Spirometric Assessment •  Post-‐bronchodilator FEV1 %

predicted classifies severity of airflow limitaLon

In paLents with FEV1:FVC < 0.70 (70%): GOLD

Classifica?on Severity FEV1 (% predicted) Exacerba?ons per year

GOLD 1 Mild FEV1 ≥ 80% predicted ?

GOLD 2 Moderate FEV1 50 – 79% predicted 0.7-‐0.9

GOLD 3 Severe FEV1 30 – 49% predicted 1.1-‐1.3

GOLD 4 Very Severe FEV1 < 30% predicted 1.2-‐2.0

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Combined Assessment of COPD

•  Symptoms •  Risk •  FEV1 •  ExacerbaLon history

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PaLent Case •  Charlie is a 58 y/o female with COPD and diabetes.

Shortness of breath when hurrying or walking uphill. Discharged from hospital 3 weeks ago for an exacerbaLon. CAT = 8. Spirometry: FEV1 68% of predicted.

•  In which GOLD Combined Assessment PaLent Group does she belong?

A B

C D

Asthma-‐COPD Overlap Syndrome (ACOS)

Feature Asthma COPD

Age of Onset •  Younger than 20 •  Older than 40 Panern of Symptoms •  Variable

•  Triggers • Worse at night or early AM •  DrasLc response to meds

•  Good and bad days but symptoms despite meds •  Chronic cough, before dyspnea

Lung FuncLon •  Variable airflow limitaLon •  Persistent airflow limitaLon •  FEV1/FVC < 0.7

Past/Family History •  Previous diagnosis or family history of asthma.

•  Previous diagnosis of chronic bronchiLs or emphysema •  Exposure to risk factor

Time Course •  No worsening of symptoms over Lme

•  Symptoms slowly progress over Lme

Chest X-‐ray •  Normal •  HyperinflaLon

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http://www.goldcopd.org/asthma-copd-overlap.html


Treatment

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Treatment Goals Reduce Symptoms Reduce Risk •  Improve exercise

tolerance •  Improve lung funcLon

(FEV1) •  Improve quality of life

and health status

•  Fewer exacerbaLons •  Less disease

progression •  Reduced mortality

PaLent Case •  Maverick is a 63 y/o male with a 30 pack-‐year smoking history

(quit 10 years ago), past medical history significant for hypertension and COPD. VaccinaLon history: o  Influenza October 2015 o  Tetanus 2012 o  Zoster 2012

•  For which vaccines will he be due within the next 3 years?

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Non-‐Pharmacologic/ProphylacLc Therapy

•  Smoking cessa?on* •  Oxygen* •  Annual influenza vaccinaLon •  Pneumococcal vaccinaLon

o  PPSV23 for all COPD paLents o  PCV13 for all paLents 65 or older

•  Pulmonary rehabilitaLon (for COPD group B-‐D) o  Exercise, nutriLon, educaLon, smoking cessaLon, behavioral health

*Mortality benefit

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COPD Risk and Smoking CessaLon

BMJ. 1977;1:1645-8.

PaLent Case •  Maverick is a 63 y/o male with a 30 pack-‐year smoking history

(quit 10 years ago), past medical history significant for hypertension and COPD. VaccinaLon history: o  Influenza October 2015 o  Tetanus 2012 o  Zoster 2012

•  For which vaccines will he be due within the next 3 years? o  Annual influenza o  Pneumovax now o  Prevnar at 65 o  No Pneumovax 2nd dose unLl 68 (5 years aser first dose)

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Pharmacologic Therapy

Overview LABA/LAMA Combo

Controversial Role of ICS

Treatment Goals – Role of Pharmacotherapy

Reduce Symptoms Reduce Risk •  Improve exercise

tolerance •  Improve lung

func?on (FEV1) •  Improve quality of

life and health status

•  Fewer exacerba?ons •  Less disease

progression •  Reduced mortality

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Pharmacologic Treatment Principles

• Inhaled treatment preferred

• Long-‐ac?ng bronchodilators preferred (LABA, LAMA)

• Consider combina?on of mechanisms

• Avoid cor?costeroid monotherapy

• Tailor device based on paLent characterisLcs

Inhaled Treatments for COPD

Bronchodilators

Beta2-‐agonists

Short-‐acLng (SABA)

Long-‐acLng (LABA)

AnLcholinergics

Short-‐acLng (SAMA)

Long-‐acLng (LAMA)

Inhaled corLcosteroids

(ICS)

Not to be used alone

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COPD Drugs Approved Since 2013 Drug Class Date

U?bron™ Neohaler® (indacaterol + glycopyrrolate) LABA/LAMA Oct 2015

S?olto™ Respimat® (Lotropium + olodaterol) LABA/LAMA May 2015

ProAir® RespiClick (albuterol) SABA Apr 2015

Striverdi® Respimat® (olodaterol) LABA July 2014

Incruse™ Ellipta™ (umeclidinium) LAMA May 2014

Anoro™ Ellipta™ (umeclidinium + vilanterol) LABA/LAMA Dec 2013

Breo® Ellipta™ (fluLcasone + vilanterol) ICS/LABA May 2013

www.centerwatch.com

Comparison of Inhaled Treatments

Short-‐ac?ng LABA LAMA ICS

•  For paLents with occasional symptoms

•  ↓ exacerbaLon rate

•  Salmeterol ↓ hospitalizaLons

•  Tiotropium ↓ exacerbaLon rate and hosp’ns

•  Tiotropium may be > salmeterol

•  ↓ symptoms & exacerbaLons

•  Bronchodilator + ICS may ↓ mortality

•  Response less rapid in COPD than asthma

•  Adherence difficult

•  No evidence for addiLon to long-‐acLng agents

•  Can worsen tremor

•  May precipitate arrhythmias in high risk paLents

•  Dry mouth •  QuesLonable

signal of ↑ CV events and mortality with ipratropium and Lotropium SMI

•  Adverse effects —  candidiasis —  myopathy —  ↑ pneumonia —  ↓ bone density?

—  cataracts •  Withdrawal?

PROS

CONS

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IniLal Treatment

GOLD 2

GOLD 1

GOLD 3

GOLD 4

No. exacerbaLons/year

1 (not leading to hosp)

0

≥2

(or ≥ 1 leading to hosp)

SABA or SAMA PRN LABA or LAMA or SABA/

SAMA

LABA or LAMA

LABA/LAMA

LABA/ICS ± LAMA

± PDE-‐4 inhibitor or LABA/LAMA

or LAMA + PDE-‐4 inhibitor

LABA/ICS or LAMA

LABA/LAMA or LAMA + PDE-‐4 inhibitor or LABA + PDE-‐4 inhibitor

A B

C D

CAT < 10

CAT ≥ 10 (Symptoms)

Assessing Treatment Response

•  Have you noLced a difference since starLng this treatment?

•  If you are bener: o  Are you less breathless? o  Can you do more? o  Can you sleep bener? o  Describe what difference it has made to you.

•  Is that change worthwhile to you?

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PaLent Case •  Maverick (63 y/o male), newly diagnosed with COPD. •  No history of exacerbaLons.

FEV1 is 60% predicted, CAT score is 12 (GOLD Group B). Symptoms are mainly dyspnea on exerLon and faLgue. No characterisLcs consistent with asthma.

•  What would you recommend as iniLal treatment for Maverick? A.  Combivent Respimat (SABA/SAMA) PRN

B.  Spiriva Respimat (LAMA) 2 inhalaLons daily

C.  SLolto Resipmat (LABA/LAMA) 2 inhalaLons daily

D.  Breo Ellipta (LABA/ICS) 1 inhalaLon daily

IniLal Treatment

GOLD 2

GOLD 1

GOLD 3

GOLD 4

No. exacerbaLons/year

1 (not leading to hosp)

0

≥2

(or ≥ 1 leading to hosp)

SABA or SAMA PRN LABA or LAMA or SABA/

SAMA

LABA or LAMA

LABA/LAMA

LABA/ICS ± LAMA

± PDE-‐4 inhibitor or LABA/LAMA

or LAMA + PDE-‐4 inhibitor

LABA/ICS or LAMA

LABA/LAMA or LAMA + PDE-‐4 inhibitor or LABA + PDE-‐4 inhibitor

A B

C D

CAT < 10

CAT ≥ 10 (Symptoms)

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LABA/LAMA vs LABA/ICS •  ILLUMINATE study (Lancet Respir Med 2013)

o  Indacaterol/glycopyrrionium vs fluLcasone/salmeterol o  PaLents without previous exacerbaLons (majority COPD Group B) o  138 mL improvement in FEV1 LABA/LAMA vs LABA/ICS @ week 26

Vogelmeier et al. Lancet Respir Med. 2013;1:51-60.

LABA/LAMA vs LABA/ICS •  LANTERN study (Int J COPD 2015)

o  Indacaterol/glycopyrrionium vs fluLcasone/salmeterol o  PaLents with 0-‐1 exacerbaLon in previous year (Groups B and D) o  Primary endpoint: FEV1; Secondary endpoint: exacerbaLons

Zhong et al. Int J COPD. 2015;10:1015–1026

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LABA/LAMA vs LABA/ICS •  LANTERN study (Int J COPD 2015)

o  Indacaterol/glycopyrrionium vs fluLcasone/salmeterol o  PaLents with 0-‐1 exacerbaLon in previous year (Groups B and D) o  Primary endpoint: FEV1; Secondary endpoint: exacerbaLons

Zhong et al. Int J COPD 2015;10:1015–1026.

Indacaterol/glycopyrronium

FluLcasone/salmeterol

LABA/LAMA vs LAMA •  SPARK study (Lancet Respir Med. 2013)

o  Indacaterol/glycopyrronium vs glycopyrronium vs Lotropium o  GOLD Group C and D (at least 1 exacerbaLon previous year) o  12% reducLon in exacerbaLons LABA/LAMA vs Glycopyrronium o  Similar adverse events in all 3 groups, most frequent: COPD worsening

Wedzicha et al. Lancet Respir Med. 2013;1(3):199-209.

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Monotherapy vs Dual BronchodilaLon

Adapted from Beeh KM, Beier J. Adv Ther. 2010;27:150-9.

Insurance Coverage LABA/LAMA Combo S?olto Respimat Anoro Ellipta U?bron Neohaler

Humana Medicare Pref Pref NC BCBS Medicare NC Pref NC Silverscript Medicare NC Pref NC Presbyterian Medicare NC Tier 4 (ST) NC AARP Medicare Pref Pref NC BCBS Centennial NC NC NC Molina Centennial NC NC NC Pres Centennial NC Pref NC UHC Centennial NC Pref NC Express Scripts Pref Pref NC

As of March 31, 2016

Pref = Preferred; NC = Not Covered; ST = Step Therapy

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PaLent Case •  69 year old female with a history of COPD, diagnosed 2 years

ago with hospital admission for exacerbaLon. History of smoking, quit 2 years ago aser exacerbaLon. No exacerbaLons within last 2 years. CAT score = 17, chronic cough and sputum. FEV1 = 52%. On Symbicort 160/4.5 mcg, 2 puffs BID.

•  How should this paLent’s COPD be treated?

ICS Withdrawal Studies •  COSMIC study 2005

o  History of 2 or more exacerbaLons in last year o  3 month run-‐in with salmeterol/fluLcasone

•  Followed by 12 months treatment with salmeterol vs salmeterol/fluLcasone o  Decrease in lung funcLon (FEV1) but no change in exacerbaLon rate

•  WISDOM study (NEJM 2014) o  GOLD Groups C and D o  6 week run in with ICS/LABA/LAMA

•  Randomized to 3-‐step withdrawal of ICS or conLnued triple therapy x 1 year o  No difference in Lme to exacerbaLon (primary endpoint) o  5% decrease FEV1 (38 mL), no increase in symptoms

•  Occurs over first 3 weeks, then no further decline (Magnussen et al 2016)

Wouters et al. Thorax. 2005;60(6):480-487. Magnussen et al. N Engl J Med. 2014;371(14):1285-4. Magnussen. Eur Respir J 2016; 47:651-654.

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ICS Withdrawal Studies •  INSTEAD study (Eur Resp J 2014)

o  Less severe COPD, no history of exacerbaLons o  PaLents on at least 3 months of fluLcasone/salmeterol o  Randomized to conLnued therapy or switch to indacaterol x 26 weeks o  Primary outcome: FEV1 -‐ no change

•  Not powered for exacerbaLons, but rate numerically lower with indacaterol than fluLcasone/salmeterol

Rossi et al. Eur Respir J 2014;44:1548–1556.

Controversial Role of ICS •  European Medicines Agency

o  Pharmacovigilance Risk Assessment Comminee (PRAC)

o March 18, 2016 – Results of PRAC Review of ICS •  Confirmed increased risk of pneumonia with ICS in COPD

•  No difference in rate of pneumonia between different ICS inhalers

•  Benefits of ICS use sLll outweigh risk of pneumonia

o  AwaiLng the Agency’s final stance on whether ICS are safe

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Controversial Role of ICS •  From the 2016 GOLD Guidelines…

Long-‐term treatment containing inhaled corLcosteroids should not be prescribed outside their indicaLons, due to the risk of pneumonia and the possibility of an increased

risk of fractures following long-‐term exposure

Long-‐term treatment with inhaled corLcosteroids is recommended for paLents with severe and very severe

COPD and frequent exacerba?ons that are not adequately controlled by long-‐acLng bronchodilators

http://www.goldcopd.org/asthma-copd-overlap.html

Treatment: ICS, usually with long-‐acLng bronchodilator(s)


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PaLent Case •  69 year old female with a history of COPD, diagnosed 2 years

ago with hospital admission for exacerbaLon. History of smoking, quit 2 years ago aser exacerbaLon. No exacerbaLons within last 2 years. CAT score = 17, chronic cough and sputum. FEV1 = 52%. On Symbicort 160/4.5 mcg, 2 puffs BID.

•  How should this paLent’s COPD be treated?

New Algorithm for COPD Management (Proposed)

Cooper et al. Lancet Respir Med. 2015;3:266-268.

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Devices and AdministraLon

Available Devices

MDI • Metered dose inhaler

• Difficult to coordinate breath

• Valved holding chamber helpful

• Contains propellants

DPI • Dry powder inhaler

• Requires forceful inhalaLon

SMI • Sos mist inhaler • Slow steady mist • No shaking or spacer required

Nebulizer • Not portable • Expensive • No coordinaLon of breath required

• ConLnue only if symptomaLc benefit clear

Device selecLon depends on paLent characterisLcs and cost/insurance formulary

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Dry Powder Inhalers (DPI) “All-‐In-‐One” Devices

Trade Name(s) Device Inhala?on Advair® (LABA/ICS) Serevent® (LABA)

Diskus® Quick, deep breath

Tudorza™ (LAMA) Pressair™ Breo® (LABA/ICS) Anoro™ (LABA/LAMA) Arnuity™ (ICS)

Ellipta™

Long, steady, deep breath

ProAir® (SABA) RespiClick

Ellipta™

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Insurance Coverage LAMA

Tudorza Pressair

Spiriva Handihaler

Spiriva Respimat

Incruse Ellipta

Seebri Neohaler

Humana Medicare Tier 4 (NP) Pref Pref NC NC BCBS Medicare NC Pref Pref NC NC Silverscript Medicare NC NC Tier 4 (NP) Pref NC

Presbyterian Medicare Pref Pref Pref NC NC AARP Medicare NC Pref Pref NC NC BCBS Cent NC Pref Pref Pref NC

Molina Cent Pref NC NC Pref NC

Pres Cent Pref Pref Pref NC NC UHC Cent NC NC NC Pref NC

Express Scripts Pref Pref Pref Pref NC

As of March 31, 2016

ProAir® RespiClick

OPEN INHALE CLOSE

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Dry Powder Inhalers (DPI)

Trade Name Device Inhala?on

Spiriva® (LAMA) Handihaler® Quick, deep breath

Foradil® (LABA) Aerolizer®

ArcaptaTM (LABA) NeohalerTM

“Assembly-‐Required” Devices Trade Name Device Inhala?on

Spiriva® (LAMA) Handihaler®

Quick, deep breath

Foradil® (LABA) Aerolizer®

Arcapta® (LABA) Neohaler® ULbron™ (LABA/LAMA) Neohaler®

Neohaler®

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Trade Name Device Inhala?on Combivent® (SABA/SAMA)

Respimat® Slow, deep breath Spiriva® (LAMA) SLolto™ (LABA/LAMA) Striverdi® (LABA)

Sos Mist Inhalers (SMIs) Respimat® First Time Use

Load cartridge Prime Ready to use

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Respimat® Inhaled Short-‐AcLng Bronchodilators

Drug Device Dose Frequency Dura?on of Ac?on

Albuterol ProvenLl® HFA ProAir® HFA Ventolin® HFA

MDI 1-‐2 puffs (90 mcg/puff)

every 4-‐6 hours PRN

4-‐6 hours

Albuterol ProAir®

Respiclik™ (DPI)

1-‐2 inhalaLons (90 mcg/puff)


4-‐6 hours

Albuterol AccuNeb®

Nebulized SoluLon

2.5 mg every 4-‐6 hours PRN

4-‐6 hours

Levalbuterol Xopenex® HFA

MDI 2 puffs (45 mcg/puff)


6-‐8 hours

Levalbuterol Xopenex®

Nebulized SoluLon

0.63 mg every 6-‐8 hours PRN

6-‐8 hours

SABA

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Inhaled Short-‐AcLng Bronchodilators


Ipratropium Atrovent® HFA

MDI 2 puffs (17 mcg/puff)

four Lmes daily, up to 12 puffs/day

6-‐8 hours

Ipratropium

Nebulized SoluLon

0.5 mg every 6-‐8 hours 6-‐8 hours

SAMA

SABA + SAMA Drug Device Dose Frequency Dura?on of Ac?on

Ipratropium /albuterol Combivent®

Respimat® SMI

1 inhalaLon (20 mcg/100

mcg)

every 6 hours, up to every 4 hours

6-‐8 hours

Ipratropium /albuterol Duoneb®

Nebulized SoluLon

0.5 mg/2.5 mg every 6 hours, up to every 4 hours

6-‐8 hours

Inhaled Long-‐AcLng Bronchodilators


Salmeterol Serevent®

Diskus® DPI

1 inhalaLon (50 mcg tab)

twice daily 12 hours

Formoterol Foradil®

Aerolizer® DPI

1 inhalaLon (12 mcg cap)

twice daily 12 hours

Formoterol Perforomist®

Nebulized SoluLon

20 mcg twice daily 12 hours

Arformoterol Brovana®

Nebulized SoluLon

15 mcg twice daily 12 hours

Indacaterol ArcaptaTM

NeohalerTM

DPI 1-‐2 inhalaLon (75 mcg cap)

once daily 24 hours

Olodaterol Striverdi®

Respimat® SMI

2 inhalaLons (2.5 mcg)

once daily 24 hours

LABA

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Inhaled Long-‐AcLng Bronchodilators


Tiotropium Spiriva®

Handihaler® DPI

2 inhalaLons (18 mcg cap) once daily 24 hours

Tiotropium Spiriva®

Respimat® SMI

2 inhalaLons (2.5 mcg/inh) once daily 24 hours

Aclidinium TudorzaTM

PressairTM DPI

1 inhalaLon (400 mcg tab) twice daily 12 hours

Umeclidinium IncruseTM

ElliptaTM DPI

1 inhalaLon (62.5 mcg) once daily 24 hours

Glycopyrrolate Seebri®

Neohaler® (DPI) LAMA Twice a day 12 hours

LAMA

Single Agent Inhaled CorLcosteroids

Drug Device Dose Frequency

Flu.casone propionate Flovent® HFA

MDI 1 puff (250 mcg/puff) twice daily

Flu.casone propionate Flovent®

Diskus® DPI

1 inhalaLon (50 mcg/inh) twice daily

Beclomethasone Qvar® HFA MDI 40 to 400 mcg per

day twice daily

Budesonide Pulmicort®

Flexhaler® MDI

1 puff (180 mcg/puff) twice daily

Flu.casone furoate Arnuity®

ElliptaTM DPI

1 puff (100 or 200 mcg/

puff) once daily

No single-‐agent ICS are FDA-‐approved for COPD; should be used with long-‐acLng bronchodilator

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Inhaled CombinaLon Products


Flu=casone propionate/ salmeterol Advair®

Diskus® DPI

1 inhalaLon (250/50 mcg) twice daily 12 hours

Budesonide/formoterol Symbicort® MDI 2 puff

(160/4.5 mcg) twice daily 12 hours

Flu=casone furoate/ vilanterol Breo®

ElliptaTM DPI

1 inhalaLon (100/25 mcg) once daily 24 hours

LABA/ICS

Inhaled CombinaLon Products LABA/LAMA


AnoroTM Umeclidinium/ Vilanterol

ElliptaTM DPI

1 inhalaLon (62.5/25 mcg) once daily 24 hours

SLolto™ Tiotropium/ olodaterol

Respimat® SMI

2 inhalaLons (2.5/2.5 mcg/inh) once daily 24 hours

ULbron™ Glycopyrronium/ Indacaterol

Neohaler® (DPI)

Assembly required

LABA/LAMA twice a day 12 hours

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In the Pipeline •  PDE3 and PDE4 inhibitors for inhalaLon •  Nucala (mepolizumab) – IL5 antagonist •  Budesonide/formoterol/glycopyrronium combinaLon inhaler

Gross. COPD. 2016; 3(1): 498-502.

Summary •  COPD

o GOLD combined assessment: symptoms (CAT score), FEV1, and exacerbaLon history

o Long-‐acLng bronchodilators for most paLents o Inhaled corLcosteroids only for paLents with high exacerbaLon risk

o Longer-‐acLng and combinaLon formulaLons becoming more available

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Summary •  GOLD combined assessment: symptoms (CAT score), FEV1, and exacerbaLon history

•  Pharmacotherapy improves symptoms and reduces risk of exacerbaLons, but no impact on mortality or lung decline

•  Long-‐acLng bronchodilators for most paLents •  Inhaled corLcosteroids only for paLents with high exacerbaLon risk

•  Safe to withdraw ICS in non-‐exacerbators without characterisLcs of asthma

•  Longer-‐acLng and combinaLon formulaLons becoming more available

QuesLons? Juliann Horne [email protected]

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References •  Global Strategy for the Diagnosis, Management and Preven.on of COPD, Global

IniLaLve for Chronic ObstrucLve Lung Disease (GOLD) 2016. Available from: hnp://www.goldcopd.org/.

•  American Lung AssociaLon. Chronic obstrucLve pulmonary disease (COPD) fact sheet. Updated May 2014. Accessed at hnp://www.lung.org/lung-‐disease/copd/resources/facts-‐figures/COPD-‐Fact-‐Sheet.html. Accessed on February 23, 2015.

•  CenterWatch. FDA Approved Drugs for Pulmonary/Respiratory Diseases. Updated March 2015. Accessed at hnps://www.centerwatch.com/drug-‐informaLon/fda-‐approved-‐drugs/therapeuLc-‐area/18/pulmonary-‐respiratory-‐diseases. Accessed on May 8, 2015.

•  Lexicomp Online®, Lexi-‐Drugs®, Hudson, Ohio: Lexi-‐Comp, Inc.; January 29, 2015. •  Fletcher C, Peto R. The natural history of COPD. BMJ. 1977;1:1645-‐1648. •  Gross N. COPD pipeline XXX. Chronic Obstr Pulm Dis (Miami). 2016; 3(1): 498-‐502.

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Stable COPD – IniLal Management

Pa?ent Group First Choice Second Choice

Group A SABA PRN or

SAMA PRN

LABA or

LAMA or

SABA + SAMA

Group B LABA or

LAMA

LABA + LAMA

Stable COPD – IniLal Management

*PDE-‐4 inhibitor only recommended if chronic bronchiLs present

Pa?ent Group First Choice Second Choice

Group C ICS + LABA or

LAMA

LABA + LAMA or

LAMA + PDE-‐4 inhibitor* or

LABA + PDE-‐4 inhibitor* Group D ICS + LABA

or ICS + LAMA

ICS + LABA + LAMA or

ICS + LABA + PDE-‐4 inhibitor* or

LABA + LAMA or

LAMA+ PDE-‐4 inhibitor*

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Oral Treatments for COPD •  Methylxanthines (theophylline, aminophylline) o Narrow therapeuLc index, drug interacLons o Less well tolerated and less effecLve than inhaled bronchodilators

•  MucolyLcs o N-‐acetylcysteine may have anLoxidant effects, could have a role in the treatment of paLents with recurrent exacerbaLons (Evidence B).

o Roflumilast (Daliresp)

Oral Treatments for COPD •  PDE-‐4 inhibitor (roflumilast = Daliresp®)

o  Approved February 2011 o  500 mcg PO daily o  Inhibits inflammaLon by prevenLng breakdown of cAMP o  Adverse effects: diarrhea, weight loss; suicide cauLon o  Contraindicated in moderate to severe hepaLc insufficiency o  Always use in combinaLon with at least one long-‐acLng bronchodilator

o  Reduces exacerbaLons in paLents with severe COPD (FEV1 < 50% predicted, chronic bronchiLs, frequent exacerbaLons)

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REACT Trial (March 2015) •  1-‐year, double-‐blind, controlled, mulLcenter study •  Inclusions

o  Age 40 or older o  20 pack-‐years or more o  FEV1 ≤ 50% predicted, symptoms of chronic bronchiLs, history of 2 or more

exacerbaLons in the past year, with cough and sputum o  On LABA/ICS ± LAMA for 12 months

•  Randomized to roflumilast/placebo + baseline inhaled therapy

•  Results (n=1,945) o  15-‐20% reducLon in moderate to severe exacerbaLons o  Improvements in pulmonary funcLon tests o  No difference in paLent reported symptoms

Martinez et al. Lancet. 2015;385:857-66.

Spirometry Results

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Available Products by Device Medica?on MDI DPI SMI Nebulized

Albuterol ProvenLl HFA Proair HFA Ventolin HFA

AccuNeb

Levalbuterol Xopenex HFA Xopenex

Ipratropium Atrovent HFA Ipratropium

Albuterol/ Ipratropium

Combivent Respimat Duoneb

Salmeterol Serevent Diskus

Formoterol Foradil Aerolizer Perforomist

Arformoterol Brovana

Indacaterol Arcapta Neohaler

Olodaterol Striverdi Respimat

Available Products by Device Medica?on MDI DPI SMI Nebulized

Tiotropium Spiriva Handihaler Spiriva Respimat

Aclidinium Tudorza Pressair

Umeclidinium Incruse Ellipta

FluLcasone propionate

Flovent HFA Flovent Diskus

Beclomethasone Qvar HFA

Budesonide Pulmicort Flexhaler Budesonide

FluLcasone prop/salmeterol

Advair HFA Advair Diskus

Budesonide/ formoterol

Symbicort

Mometasone/ formoterol

Dulera

FluLcasone furoate/vilanterol

Breo Ellipta

Umeclidinium/ vilanterol

Anoro Ellipta

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DefiniLon •  Common preventable and treatable pulmonary disease •  Characterized by airflow limitaLon •  Chronic inflammatory response in the airways and the lung to

noxious gases/parLcles •  Usually progressive •  Characterized by emphysema and chronic bronchiLs •  No cure

NO CURE

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COPD Cycle COPD

Dyspnea

Immobility Social IsolaLon

Depression

Lack of Fitness

COPD & ComorbidiLes •  CAD, heart failure, atrial fibrillaLon, and hypertension should

be treated according to current guidelines o  In Afib, use of high doses of beta-‐agonists can make heart rate control more difficult

•  Beta-‐blockers o  When indicated, B-‐blocker benefits outweigh risk

o  Consider B1 selecLve if possible

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Pressair Tudorza Pressair (aclidinium)

•  New FDA Warning April 2015 •  Based on post-‐markeLng reports

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Advair Diskus Spiriva Handihaler

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Foradil Aerolizer

horne copd update 2016 4.15.16 - new mexico society of ...nmshp.org/resources/documents/2016 spring...

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