How to Treat COPD: Choosing the Right Device for Maintenance

How to Treat COPD:
Choosing the Right Device for Maintenance
December 8, 2012
Baltimore, Maryland
Educational Partner:
Session 3: How to Treat COPD:
Choosing the Right Device for Maintenance
Learning Objectives
1.
2.
3.
Develop appropriate COPD management strategies for patients who have physical or mental comorbidities, as well
as others who are difficult to manage.
Compare the utility and effectiveness of the different types of inhalation devices used in COPD maintenance.
Increase awareness, knowledge, and confidence in selecting nebulization maintenance therapy for COPD patients
requiring or preferring this form of therapy.
Faculty
Amir Sharafkhaneh, MD, PhD, DABSM
Associate Professor of Medicine
Baylor College of Medicine
Houston, Texas
Dr Sharafkhaneh graduated from Tehran University of Medical Sciences. He completed residency training in internal
medicine at Long Island College Hospital in Brooklyn, New York, and a pulmonary, critical care, and sleep medicine
fellowship at Baylor College of Medicine in Houston. During the fellowship, he was involved in the National Emphysema
Treatment Trial, evaluating role of lung volume reduction surgery in management of patients with severe COPD.
Currently an associate professor of medicine at Baylor College of Medicine, Dr Sharafkhaneh is a staff attending at Michael
E. DeBakey VA Medical Center, where he is in charge of the care coordination program for COPD. There he established a
productive COPD clinical research operation and has led many observational, epidemiological, and clinical trials that have
been reported in various peer-reviewed journals. He recently coauthored COPD: A Guide to Diagnosis and Clinical Management
for primary care providers. As part of his interest in improving quality of life in patients with COPD, Dr Sharafkhaneh is
actively engaged in investigating sleep problems in COPD patients.
Stanley B. Fiel, MD, FACP, FCCP
Professor of Medicine
Mount Sinai School of Medicine
New York
Regional Chairman, Department of Medicine
Atlantic Health System
deNeufville Professor and Chairman
Department of Medicine, Morristown Medical Center
Morristown, New Jersey
Dr Fiel graduated from the Medical College of Pennsylvania in Philadelphia. He completed an internship and residency at
Temple University Hospital in Philadelphia and a fellowship in the pulmonary disease section of the Hospital of the
University of Pennsylvania.
A professor of medicine at Mount Sinai School of Medicine, Dr Fiel also has clinical appointments as regional chairman of
the department of medicine for the Atlantic Health System and as deNeufville Professor and chairman of the department of
medicine at Morristown Medial Center. His major research interests include therapeutic advances in the treatment of
obstructive pulmonary disorders including asthma, cystic fibrosis, bronchiectasis, and chronic obstructive pulmonary disease.
Complementing his research endeavors, Dr Fiel writes for the medical literature and has more than 150 published articles to
his credit. His work has appeared in such publications as The New England Journal of Medicine, JAMA, American Journal of
Respiratory and Critical Care Medicine, and Chest. Dr Fiel is a fellow of the American College of Physicians and the American
College of Chest Physicians.
Session 3
Faculty Financial Disclosure Statements
The presenting faculty report the following:
Amir Sharafkhaneh, MD, PhD, DABSM, has served as a consultant on the advisory board of Mylan Inc.
Stanley B. Fiel, MD, FACP, FCCP, has served as a consultant for PTC Therapeutics, Novartis, Boehringer Ingelheim, Bayer,
and Pfizer; has received grant/research support from Boehringer Ingelheim, Novartis, CFF, MPEX, Gilead, Transave, and
Vertex; has served on the speakers bureau for Pfizer, Novartis, Genentech, Gilead, GlaxoSmithKline, and Mylan Specialty.
Education Partner Financial Disclosure Statement
The content collaborators at Educational Concepts in Medicine report the following:
Patrick J. Crowley, MBA, Managing Director; Cassie Rametta, BA, Senior Program Manager; Jeannette Fee, Director of
Editorial Services; and Laurel Ranger, Medical Writer, have no financial relationships to disclose.
Suggested Reading List
Asche CV, Leader S, Plauschinat C, et al. Adherence to current guidelines for chronic obstructive pulmonary disease
(COPD) among patients treated with combination of long-acting bronchodilators or inhaled corticosteroids. Int J COPD.
2012;7:201-209.
Barrons R, Pegram A, Borries A. Inhaler device selection: special considerations in elderly patients with chronic obstructive
pulmonary disease. Am J Health-Syst Pharm. 2011;68(13):1221-1232.
Effing T, Monninkhof EM, van der Valk PD, et al. Self-management education for patients with chronic obstructive
pulmonary disease. Cochrane Database Syst Rev. 2007;(4):CD002990.
Einarsdottir K, Preen DB, Emery JD, et al. Regular primary care lowers hospitalization risk and mortality in seniors with
chronic respiratory diseases. J Gen Intern Med. 2009;25(8):766-773.
Gelberg J, McIvor RA. Overcoming gaps in the management of chronic obstructive pulmonary disease in older patients.
Drugs Aging. 2010;27(5):367-375.
Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and
prevention of chronic obstructive pulmonary disease (updated 2010).
http://www.goldcopd.org/uploads/users/files/GOLDReport_April112011.pdf. Accessed July 4, 2012.
Han MK, Agusti A, Calverley PM, et al. Chronic obstructive pulmonary disease phenotypes: the future of COPD. Am J
Respir Crit Care Med. 2010;182(5):598-604.
Hanania NA, Sharma G, Sharafkhaneh A. COPD in the elderly patient. Semin Respir Crit Care Med. 2010;31(5):596-606.
Melani AS. Inhalatory therapy training: a priority challenge for the physician. Acta Biomed. 2007;78(3):233-245.
Nazir SA, Erbland ML. Chronic obstructive pulmonary disease: an update on diagnosis and management issues in older
adults. Drugs Aging. 2009;26(10):813-831.
Perez X, Wisnivesky JP, Lurslurchachai L, et al. Barriers to adherence to COPD guidelines among primary care providers.
Respir Med. 2012;106(3):374-381.
Sharafkhaneh A, Petersen NJ, Yu HJ, et al. Burden of COPD in a government health care system: a retrospective
observational study using data from the US Veterans Affairs population. Int J COPD. 2010;5:125-132.
Tashkin DP, Hanania NA, McGinty J, et al. Nebulized formoterol provides added benefits to tiotropium treatment in
chronic obstructive pulmonary disease. Adv Ther. 2009;26(11):1024-1034.
Session 3
Presenter Disclosure Information
Session 3
12:30 PM- 1:45 PM
The following relationships exist related to this
presentation:
• Amir Sharafkhaneh, MD, PhD, DABSM, has served as a
consultant on the advisory board of Mylan Inc.
• Stanley B. Fiel, MD, has served as a consultant for PTC,
Novartis, Boehringer Ingelheim, Bayer, Pfizer; has received
Grant/Research Support from Boehringer Ingelheim, Novartis,
CFF, MPEX, Gilead, Transave, Vertex; has served on the
Speakers Bureau for Pfizer, Novartis, Genentech, Gilead,
GlaxsoSmithKline, Mylan Specialty.
How to Treat COPD:
Choosing the Right Device for Maintenance
Speakers:
Amir Sharafkhaneh, MD, PhD, DABSM
Stanley B. Fiel, MD
Off-Label/Investigational Discussion
In accordance with pmiCME policy, faculty have been asked to
disclose discussion of unlabeled or unapproved use(s) of drugs
or devices during the course of their presentations.
Drug List
Drug List (cont)
Generic Name
Brand Name
Generic Name
Brand Name
albuterol
Various
fluticasone propionate salmeterol
Advair Diskus®, Advair® HFA
aclidinium
TudorzaTM PressairTM
formoterol
Foradil®, Perforomist®
albuterol and ipratropium
Various
indacaterol
ArcaptaTM NeohalerTM
arformoterol
Brovana® Inhalation Solution
ipratropium
Atrovent®, Atrovent® HFA
beclomethasone dipropionate
Beconase AQ®, QNASL® Nasal Aerosol, QVAR® Inhalation Aerosol
levalbuterol
Xopenex®, Xopenex® HFA
levodopa
Parcopa®, Sinemet®, Stalevo®
budesonide
Pulmicort®, Pulmicort Flexhaler®, Pulmicort Respules®, Rhinocort® Aqua®
mometasone furoate
Asmanex Twisthaler®
budesonide/formoterol
SymbicortTM
pirbuterol
Maxair® Autohaler®
ciclesonide
Alvesco® Inhalation Aerosol, Omnaris® Nasal Spray, ZetonnaTM Nasal Aerosol
roflumilast
Daliresp® Tablets
fluticasone propionate
Flonase®, Flovent®, Flovent® Diskus®, Flovent® HFA
salmeterol
Advair®, Serevent® Diskus®
theophylline
Various
tiotropium
Spiriva® HandiHaler®
6
7
Demographic Question
Learning Objectives
Relative to COPD: please indicate the
approximate number of patients that you
see each week with this condition.
• Develop appropriate chronic obstructive pulmonary disease (COPD) management strategies for patients who have physical or mental comorbidities as well as others who are difficult to manage
• Understand diagnosis and optimal management of COPD by discussing guideline updates
• Compare the utility and effectiveness of the different types of inhalation devices used in COPD maintenance • Increase awareness, knowledge, and confidence in selecting nebulization maintenance therapy for COPD patients requiring or preferring this form of therapy
1.
2.
3.
4.
5.
6.
7.
8.
8
1
None
1 to 10
11 to 20
21 to 30
31 to 40
41 to 50
51 to 60
> 60
?
?
Polling Question
?
Polling Question
Among your patients receiving maintenance therapy for COPD, how would you describe their level of adherence?
How often do you prescribe long‐acting beta2‐agonists (LABAs) for maintenance therapy for your COPD patients?
1. Excellent—almost all of my patients adhere to their prescribed regimen
2. Good—most of my patients adhere to their prescribed regimen
3. Fair—at least half of my patients adhere to their prescribed regimen
4. Poor—less than half of my patients adhere to their prescribed regimen
1.
2.
3.
4.
Always
Usually
Sometimes
Never
10
Polling Question
11
?
Polling Question
How confident do you feel about selecting an appropriate LABA and delivery device for maintenance therapy for your patients based on their individual characteristics?
How confident do you feel about your ability to instruct patients in the use of a dry powder inhaler (DPI) for maintenance therapy?
1.
2.
3.
4.
1.
2.
3.
4.
Very confident
Somewhat confident
Not very confident
Not confident at all
Very confident
Somewhat confident
Not very confident
Not confident at all
12
Polling Question
?
13
?
Case Study 1
• George W., a 75-year-old retired office worker with a 10-year history
of COPD recently has been experiencing more shortness of breath
and difficulty helping his wife around the house. He also has
required frequent SABA refills.
• George smoked a pack of cigarettes a day for 50 years, but quit at
diagnosis of COPD. He has osteoarthritis, particularly in the hands,
and also suffers from type 2 diabetes mellitus (DM). He has had
several transient ischemic strokes over the last few years.
• Medications:
– LABA using a dry powder inhaler as COPD maintenance
therapy, as well as a SABA for rescue therapy and an oral
glucocorticoid for treatment of acute exacerbations
– A sulfonylurea for glucose control
– An antiplatelet agent to reduce the risk of stroke
– A nonsteroidal anti-inflammatory drug for osteoarthritis
15
In elderly patients with cognitive problems and/or physical
disabilities, what would you typically prescribe for maintenance therapy?
1. I don’t prescribe therapy for these patients
2. I prescribe a short‐acting beta2‐agonist (SABA) for rescue therapy as needed rather than a LABA for maintenance 3. I prescribe a LABA using a breath‐activated inhaler (ie, nebulizers
that generate aerosol only on inspiration) for these patients and a SABA for rescue therapy as needed
4. I prescribe a LABA /inhaled corticosteroid (ICS) fixed dose combination
5. I prescribe a LABA using a nebulizer for these patients and a SABA for rescue therapy as needed
14
2
Case Study 1—Poor Disease Control
Case Study 1—Course of Action
• Signs of possible nonadherence
– Frequent exacerbations
– Patient is going through rescue medication
too quickly
– Forced expiratory volume in 1 second
(FEV1)% predicted has declined more than
expected
• George is asked about his use of LABA and SABA
therapy, and he admits to inconsistent use of LABA
maintenance therapy and difficulty in using his inhaler
• An office demonstration of how he is using the LABA
inhaler shows that his technique is poor, and, as a result,
it is unlikely that much of the medication is reaching the
lungs
• George is prescribed a LABA using a nebulizer
• He is educated on the need to use the maintenance
therapy and to reserve rescue medication only for
breakthrough episodes
16
17
Case Study 1—Follow-up
COPD
• At the next visit 3 months later, George expresses
satisfaction with the nebulizer and its ease of use
• He reports needing less rescue medication and having
fewer symptoms. He is able to help around the house
and has even begun taking a short walk every morning
COPD—Overview
18
19
Epidemiology of COPD
Epidemiology of COPD
• ~14 million American adults have been diagnosed with
COPD1
• COPD death rate increased 102.8% between
1970 and 2002
– The true prevalence is probably higher because many
individuals with mild grade COPD remain asymptomatic2
• 63% of adults with expiratory airflow obstruction are not
aware of their problem
– Among the 6 leading causes of death, only COPD and DM had
an increase in the death rate
• Death rate in DM increased 3.2% during that time period
– Death rates decreased in heart disease (-52.1%), cancer
(-2.7%), accidents (-41%), and stroke (-63.1%) between 1970
and 2002
• Chronic and unspecified bronchitis accounts for 11.7
million visits to physicians’ offices, hospital outpatient
clinics, and emergency departments (ED) annually1
– Other COPD accounts for 6.1 million visits
• COPD is the third leading cause of death in the U.S.3
1. CDC. FastStats. Available at http://www.cdc.gov/nchs/fastats/copd.htm. Accessed July 4, 2012. 2. Mapel DW, et al. J Manag Care Pharm. 2006;12:458‐465. 3. CDC. National Vital Statistics Report. Vol. 60, No. 3. December 29, 2011. Available at http://www.cdc.gov/nchs/data/nvsr/nvsr60/nvsr60_03.pdf. Accessed August 21, 2012.
Jemal A, et al. JAMA. 2005;294:1255‐1259.
20
3
21
COPD—Disease Course
COPD—Assessment
• The natural course of COPD is variable
• COPD is a progressive disease
• COPD is a chronic, incurable disease, but treatment can
reduce symptoms, increase exercise tolerance, improve
quality of life (QOL), reduce exacerbations, and perhaps
decrease mortality
• Spirometric assessment
– However, the correlation between FEV1, symptoms,
and impairment of a patient’s health-related QOL is
weak
Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011. Available from: http://www.goldcopd.org. Accessed September 6, 2012. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011. Available from: http://www.goldcopd.org. Accessed September 6, 2012. 22
COPD—Assessment
COPD—Classification
• Symptom assessment
• Revised 2011 GOLD Guidelines published in December
presented a new system for classifying COPD
– Modified British Medical Research Council (mMRC)1
questionnaire
• Measures breathlessness
• Score ranges from Grade 0 (only get breathless with
strenuous exercise) to Grade 4 (too breathless to leave the
house or breathless when dressing or undressing)
– COPD Assessment Test (CAT)1
• 8-item unidimensional measure of health status impairment1
– Score for individual items ranges from 0 (best) to 5
(worst)2
• Designed to be relevant worldwide1
• Total score ranges from 0-401
1. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011. Available from: http://www.goldcopd.org. Accessed September 6, 2012. 2. COPD Assessment Test. Available at http://www.catestonline.org.
– Change from stages I-IV to grades A-D
– New system takes into account airflow limitation, exacerbations, and
symptoms based on either mMRC or CAT score
Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011. Available from: http://www.goldcopd.org. Accessed September 6, 2012. 24
COPD—Impact of Treatment
Slows disease progression and decline in FEV1; decreases morbidity and reduces mortality
Pulmonary Rehabilitation2
Immunization2
Low‐Flow Supplemental Oxygen2
25
COPD—Impact of Treatment (Cont.)
Nonpharmacologic Interventions
Smoking Cessation1
23
Pharmacologic Interventions
Bronchodilators
Includes respiratory muscle training, exercise training, strength and endurance training
Include beta2‐agonists, anticholinergics, and methylxanthines; short acting reserved for rescue; long‐acting used for maintenance for moderate to severe COPD
Inhaled Corticosteroids (ICS)
Influenza and antipneumococcal vaccines may reduce hospitalization due to influenza and pneumonia
Decreases exacerbation frequency in patients with an FEV1 < 60% predicted; does not modify long‐term decline of FEV1
Phosphodiesterase‐4 (PDE‐4) Inhibitors
For patients with significant hypoxemia or evidence of pulmonary hypertension, peripheral edema, or polycythemia; has been shown to increase survival
Improves FEV1 in patients treated with a bronchodilator; reduces moderate and severe exacerbations in patients treated with corticosteroids
Combination Therapy
Beta2‐agonists used with an anticholinergic or theophylline may improve lung function and health status; combining an ICS with a LABA may improve lung function, health status and reduce exacerbations
1. Stockley RA. Curr Med Res Opin. 2009;25:1235‐1245. 2. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011. Available from: http://www.goldcopd.org/. Accessed September 6, 2012. 1. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease 27
(GOLD) 2011. Available from: http://www.goldcopd.org/. Accessed September 6, 2012. 26
4
COPD—Impact of Treatment
GOLD Guidelines on Management of Stable COPD
• Regular and proactive maintenance in primary care
rather than reactive care is beneficial to older patients
with chronic respiratory diseases, reducing the risk of
hospitalization and death
GOLD Guidelines on the Management of Stable COPD, December 2011
• Overall approach to managing stable COPD should be
individualized to address symptoms and improve QOL
• Bronchodilator medications central to the symptomatic management
of COPD (Evidence A)
– Given on as needed basis or on regular basis to prevent or reduce
symptoms and exacerbations
• Principal bronchodilator treatments (Evidence A)
– β2-agonists,
– Anticholinergics
– Methylxanthines, used singly or in combination
• Theophylline is not recommended as first-line therapy
Einarsdottir K, et al. J Gen Intern Med. 2009;25:766‐773.
Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (Updated 2010). Available at 29
http://www.goldcopd.org/uploads/users/files/GOLDReport_April112011.pdf. Accessed July 4, 2012. 28
GOLD Guidelines on Management of Stable COPD
GOLD Guidelines on Management of Stable COPD
Most Recent Gold Guidelines—December 2011
Initial Pharmacologic Management of COPD
GOLD Guidelines on the Management of Stable COPD, December 2011
• Regular treatment with long-acting inhaled bronchodilators is more
effective and convenient than treatment with short-acting
bronchodilators (Evidence A)
• Regular treatment with long-acting inhaled bronchodilators is more
effective and convenient than treatment with short-acting
bronchodilators (Evidence A)
• Chronic treatment with systemic glucocorticosteroids should be
avoided because of an unfavorable benefit-to-risk ratio (Evidence A)
Patient Group
First Choice
Second Choice A
SAMA pm or SABA pm
LAMA or LABA or SABA + SAMA
Alternative Choice
Theophylline
B
LAMA or LABA
LAMA + LABA
SABA and/or SAMA
Theophylline
C
ICS + LABA or LAMA
LAMA + LABA
PDE‐4 inhibitor
SABA and/or SAMA
Theophylline
D
ICS + LABA or LAMA
ICS + LAMA or
ICS + LABA + LAMA or ICS + LABA + PDE‐4 inhibitor or LAMA + LABA or LAMA + PDE‐4 inhibitor
SABA and/or SAMA
Theophylline
SAMA = short‐acting muscarinic antagonist. LAMA = long‐acting muscarinic antagonist.
Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (Updated 2010). Available at 30
http://www.goldcopd.org/uploads/users/files/GOLDReport_April112011.pdf. Accessed July 4, 2012. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011. Available from: http://www.goldcopd.org/. Accessed September 6, 2012. Brochodilator Agents for COPD
ICSs for COPD
Drug Class
Agents
Duration/Delivery device
LABAs
Formoterol
12 hrs; DPI, MDI, nebulizer, oral1‐3
Salmeterol
12 hrs; DPI1,4
Arformoterol
12 hrs; nebulizer1,5
Indacaterol
24 hrs; DPI1,6
LAMAs
Long‐acting combination therapy
SABAs
31
ICS
Beclomethasone diproprionate
Delivery Device1
pMDI
Budesonide
Nebulizer
DPI
Tiotropium
24 hrs; DPI1,7
Ciclesonide
pMDI
Aclidinium
12 hrs; DPI1,8
Fluticasone propionate
DPI
pMDI
Budesonide/formeterol
12 hrs; pMDI1,9
Fluticasone propionate‐salmeterol
12 hrs; DPI, pMDI1,10
Mometasone furoate
Albuterol
3‐6 hrs; pMDI, nebulizer1,11‐14
5‐6 hrs; nebulizer, pMDI1,15
• Use of ICSs can improve lung function and symptoms and decrease airway reactivity and frequency of Levalbuterol
Pirbuterol
5 hrs; pMDI16
SAMAs
Ipatropium
2‐4 hrs; nebulizer, pMDI1,17
Short‐acting combination therapy
Albuterol + ipatropium
4‐5 hrs; pMDI, nebulizer11,18,19
1. Barrons R, et al. Am J Health Syst Pharm. 2011;68:1221‐1332. 2‐19. PDR.net website. Drug information, product labeling. www.pdr.net/drugpages/productlabelinglist.aspx. Accessed October 1, 2012. DPI
exacerbations2
• Long‐term use in the elderly increases risk of cataract formation and glaucoma, decreases bone mineral density, and increases fracture rates2
• ICS monotherapy is not an FDA‐approved medication for COPD but is recommended by evidence‐
based COPD guidelines to be considered as an add‐on to long‐acting bronchodilators in patients with severe COPD and exacerbations
32
33
1. Barrons R, et al. Am J Health Syst Pharm. 2011;68:1221‐1232. 2. Nazir SA, et al. Drugs Aging. 2009;26:813‐831.
5
Adverse Effects of COPD Medication
Adverse Effects of COPD Medication
Selected Adverse Events Associated with COPD Medication
Selected Adverse Events Associated with COPD Medication
Drug Class
Serious Adverse Effects
Common Adverse Effects
Anticholinergics
•Anaphylaxis
•Angioedema
•Bronchospasm (paradoxical)
•Glaucoma (narrow angle)
•Hypersensitivity reaction
•Laryngospasm
•Cough
•Dry mouth
•Blurred vision
•Urinary hesitancy or retention
Beta2‐agonists
•Asthma exacerbation
•Death (asthma‐related)
•Bronchospasm (paradoxical)
•Laryngospasm
•Angina, angioedema, arrhythmias, QT‐interval prolongation
•Seizures •Urticaria, anaphylaxis
•Nervousness
•Tremor
•Palpitations
•Tachycardia 34
Grimes GC, et al. Am Fam Phys. 2007;76:1141‐1148, 1151‐1152.
Drug Class
Serious Adverse Effects
Common Adverse Effects
ICSs
•Adrenal suppression
•Anaphylactoid reactions
•Angioedema
•Bronchospasm
•Churg‐Strauss syndrome
•Cushingoid features
•Glaucoma
•Hyperglycemia
•Osteoporosis
•Vasculitis
•Candidiasis (oral)
•Cough
•Throat irritation, hoarseness
•Dysphonia
•URTI
Inhaled anticholinergics/
SABAs
•Anaphylaxis
•Angioedema
•Arrhythmias
•Bronchospasm (paradoxical)
•Glaucoma (narrow angle)
•Bronchitis
•Cough
•Dyspnea
•Headache
•Nausea
•Pain
•URTI
Grimes GC, et al. Am Fam Phys. 2007;76:1141‐1148, 1151‐1152.
Adverse Effects of COPD Medication
35
Other Agents for COPD
• Theophylline1
– Narrow therapeutic window
– Adverse events include nausea, vomiting, cardiac arrhythmias, and
seizures
• These adverse effects limit its use in the elderly
Selected Adverse Events Associated with COPD Medication
Drug Class
Serious Adverse Effects
Common Adverse Effects
ICSs/LABAs
•Asthma exacerbation, death (asthma‐
related)
•Adrenal suppression,
•Angioedemia
•Arrhythmia (ventricular)
•Bronchospasm (paradoxical), laryngospasm
•Churg‐Strauss syndrome
•Cushingoid features
•Glaucoma
•Bronchitis, cough
•Candidiasis (oral), URTI
•Hoarseness, throat irritation
•Dermatitis
•Diarrhea
•Dizziness
•Headache
•Nausea or vomiting
•Palpitations
•Tremor
Grimes GC, et al. Am Fam Phys. 2007;76:1141‐1148, 1151‐1152.
• Roflumilast
– Selective PDE-4 inhibitor2
– Targets pulmonary and possibly systemic inflammation associated with
COPD2
– Indicated as treatment to reduce the risk of COPD exacerbations in
patients with severe COPD associated with chronic bronchitis and a
history of exacerbations3
– The most common adverse effects are weight loss (12%) and diarrhea
(8%)2
1. Nazir SA, et al. Drugs Aging. 2009;26:813‐831. 2. Gross NJ, et al. COPD.
2010;7:141‐153. 3. PDR.net website. Roflumilast product labeling. http://www.pdr.net/drugpages/productlabeling.aspx?mpcode=30600260. Accessed October 1, 2012.
36
Case Study 2
Polling Question
• Gayle H., a 63‐year‐old receptionist for a pediatrician has been controlled on her SABA rescue medication since being diagnosed with Grade B*
COPD 3 years ago. She smoked half a pack of cigarettes for 35 years and quit at diagnosis. She also suffers from early stage Parkinson’s disease (PD) and hypertension.
• Medications:
– Levodopa for Parkinson’s Disease
– Angiotensin‐converting enzyme (ACE) inhibitor
– SABA
• She uses her SABA rescue medication more and more frequently. Recently, she has been unable to work in her garden, even for a short while, and says she sometimes gets breathless at work and has to take a break and use rescue medication. In elderly patients with cognitive problems and/or physical
disabilities, what device would you typically prescribe for maintenance therapy?
37
?
1. MDI
2. DPI
3. Nebulizer
39
40
*Grade B, typically GOLD 1 or GOLD 2 and/or 0‐1 exacerbation per year and mMRC grade ≥ 2 or CAT score ≥ 10.
6
Case Study 2—Course of Action
Case Study 2—Follow-up
• Gayle has hand control issues due to the PD, and,
therefore, a LABA using a nebulizer is prescribed
• At a follow-up visit 3 months later, Gayle reports fewer
symptoms of COPD and less use of rescue medication
– Due to PD, she experienced specific problems with
activation, coordinating activation with inhalation, and
positioning her SABA inhaler
• Nebulizers require minimal patient cooperation and
coordination
• Two major issues in Gayle’s stable COPD management:
– General Issue: Under use of maintenance therapy
– Gayle Specific issue: Delivery of the medication
• She is educated on the need to use the LABA regularly,
as prescribed, and to reserve the SABA as rescue
medication for acute symptoms
41
Dolovich MB et al. Chest. 2005;127:335‐371.
42
COPD—Maintenance Therapy Is Underused
COPD—Maintenance Therapy Is Underused
• Retrospective medical record review of over 50,000
COPD patients
– Found that 66.3% of managed care patients are not
prescribed any maintenance therapy for COPD
• 59.1% receive no therapy
• 7.2% are prescribed an inhaled SABA only
– In the Medicare population, 70.9% of COPD patients
are not prescribed maintenance therapy
• 66% receive no therapy
• 4.9% are prescribed a SABA only
Make B, et al. Int J COPD. 2012;7:1‐9.
Baseline Respiratory Pharmacotherapy Use Among US Veterans Affairs Population
n
Treated
36,285
60.6
100.0
ICS + LABA combination
449
0.7
1.2
ICS + LABA combination 250/50
261
0.4
0.7
ICS
11,177
18.6
30.8
SABA
32,629
54.5
89.9
LABA
2176
3.6
6.0
Short‐ or long‐acting anticholinergic
13,493
22.5
37.2
Untreated
23,621
39.4
na
Sharafkhaneh A, et al. Int J COPD. 2010;5:125‐132.
43
LABAs and LAMAs
• Should be used regularly in moderate
COPD (Grade B) if symptoms are not
well controlled with as needed SABA,
and for severe to very severe COPD
(Grades C & D)1,2
• Yet, one study found only 54% of
patients were using long-acting
bronchodilators when FEV1 was < 80%
predicted3
• Poor familiarity with recommendations,
low self-efficacy, and time constraints
identified as barriers to adherence to
COPD guidelines3
% of total % of treated 59,906
36,285
44
LABAs and LAMAs (cont)
• Another study found that SABAs were used without
concomitant long-acting bronchodilators for 20% of moderate,
14% of severe, and 8% of very severe COPD patients
Patients with FEV1 < 80% Predicted Who Use Long‐acting Bronchodilators
– Long-acting bronchodilators + ICS used in 12% of patients with
moderate COPD, 19% with severe COPD, and 2% with very
severe COPD
60%
50%
54%
20%
40%
30%
15%
20%
10%
10%
0%
COPD Severity
Moderate
Severe
5%
% of Patients Using Long‐acting Bronchodilators
1. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011. Available from: http://www.goldcopd.org/. Accessed September 6, 2012. 2. Asche CV, et al. Int J COPD. 2012;7:201‐209. 3. Perez X, et al. Respir Med. 2012;106:374‐381.
Very Severe
0%
SABAs Only ICS + LABA
or LAMA
Fitch K, et al. Curr Med Res Opin. 2011;27:1425‐1429.
45
7
46
COPD—Adherence to Maintenance
LABAs and LAMAs (cont)
• Fear of complications may prevent greater use
of long-acting bronchodilators
• Adherence to maintenance regimens is also poor
– Among patients prescribed long-term therapy with
LAMA, LABA, or fixed-dose combinations of ICS and
LABA, a substantial proportion switch therapy
• Persistence, even including those who switch, is
low
– Persistence rates with any long-acting drug at 1, 2,
and 3 years has been found to be 36%, 23%, and
17%, respectively, in an analysis of a large
pharmaceutical database
– There was a small but significant increase in asthma-related
deaths with salmeterol in asthma patients, raising concerns
about LABA monotherapy in asthma patients1
– This increase was not noted in children and adolescents using
formoterol along with concomitant ICS or other LABA/ICS
combinations2,3
• However, COPD is a different disease, occurring in a different
population1
– Safety of LABAs is well-established in the COPD population1,4
– Some increased risk is associated with beta2-agonists in patients
with COPD and concomitant congestive heart failure,1
particularly if they are not treated with a cardioselective betaantagonist
Penning‐van Beest F, et al. Respir Med. 2011;105:259‐265.
47
1. Tashkin DP, et al. Respir Res. 2010;11:149. 2. Price JF, et al. Arch Dis Child. 2010;95:1047‐1053. 3. Jacobs TS, et al. J Asthma. 48
2012;49:450‐455. 4. Calverly PMA, et al. NEJM. 2007;356:775‐789.
Complications From Poor
Maintenance Therapy
Rescue Therapy—SABAs and SAMAs
• Appropriate use of SABAs and SAMAs
– These agents act more quickly than the LABA
salmeterol and LAMAs, and, therefore, are
appropriate as symptom-driven rescue therapy1
• Inappropriate use
– Frequent use of SABAs or SAMAs is a sign of poorly
controlled disease
– SABAs and SAMAS do not provide long-acting relief
of symptoms; in patients with moderate to severe
COPD, they should be used solely as rescue
medication in conjunction with maintenance therapy
with long-acting bronchodilators2
• Failure to adhere to GOLD Guidelines results in
– More frequent exacerbations
– More frequent hospitalizations
Asche CV, et al. Int J COPD. 2012;7:201‐209.
1. Ohar JA, et al. Semin Respir Crit Care Med. 2010;31:321‐333. 2. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011. Available from: http://www.goldcopd.org/. Accessed 49
September 6, 2012. 50
Identifying Patients Exhibiting Signs of
Poor Control or Nonadherence
COPD—Cost Savings of Adherence
• Clinical symptoms and signs1
– Frequent exacerbations
– Increased use of rescue medications
– Declining lung function (FEV1)
– Increased disability (greater difficulty with performing
activities of daily living [ADLs])
– Reduced ability to exercise
• Maintenance therapy in COPD decreases hospitalizations and
expenditures
Cost Savings of Adherence to GOLD Guidelines vs. Nonadherence*
Therapy
Cost Savings
LAMA+ LABA
$5889
LABA + ICS
$3330
LAMA + LABA/ICS
$10,217
*Adherent versus nonadherent: LAMA + LABA, n=25 and n=39, respectively; LABA + ICS, n=74 and n=180, respectively; LAMA + LABA/ICS, n=21 and n=25, respectively. Asche CV, et al. Int J COPD. 2012;7:201‐209.
1. Gross NJ. Proc Am Thorac Soc. 2005;2:267‐271.
51
52
8
Identifying Patients Exhibiting Signs of
Poor Control or Nonadherence
Identifying Patients Exhibiting Signs of
Poor Control or Nonadherence
• Biomarkers
• Evaluating the frequency, severity, and duration of exacerbations
– The only accepted biomarker in COPD is FEV1; however, this
proves less than optimal in many cases for monitoring response to
treatment1
– Exacerbations begin to occur in more severe disease (Grades C & D)1
• Consider re-evaluation of current treatment in patients with frequent
exacerbations (i.e. 2 or more per year)
– COPD Assessment Test—8 items, scored from 0 to 52
• Covers the domains of cough, phlegm, chest tightness, exercise
limitations, limitations of ADLs, sense of confidence, sleep
disturbances, level of energy
• Score of 10 or more indicates a level of symptoms warranting more
aggressive management
– Markers of exacerbation severity3
• Arterial carbon dioxide tension and breathing rate associated with
the severity of COPD exacerbations
– Some promising biomarkers are on the horizon, but clinical data
are not consistent1
• Serum PARC/CCL-18 independently associated with health
outcomes2
• ECLIPSE cohort3
– Fibrinogen, surfactant protein D, and CC-16 may be useful
– More research is needed to determine if these can provide
information about disease phenotype, severity, and/or
progression
• Phenotypes—COPD is a complex and heterogeneous disease4
– In some cases, phenotype may help predict response to
treatment5
1. Yoon HI, et al. Drugs. 2011;71:1821‐1837. 2. Sin DD, et al. Am J Respir Crit Care Med. 2011;183:1187‐1192. 3. Dickens JA, et al. Respir Res. 2011;12:146‐156. 4. Han MK, et al. Am J Respir Crit Care Med. 2010;182:598‐604. 5. Agusti A, et al. Eur
Respir J. 2011;38:749‐751. 1. Jones PW, et al. Chest. 2011;139:1388‐1394. 2. Mackay AJ, et al. Am J Respir Crit Care Med. 2012;184:1218‐1224. 3. Franciosi LG, et al. Respir Res. 2006;7:74.
53
54
COPD—Difficult-to-Treat Patients
COPD—Difficult-to-Treat Patients
• Disabilities may be a barrier to adherence
and disease control1
• Subpopulations of difficult-to-treat COPD patients make disease
management a challenge
– Elderly patients may have cognitive deficits that make
adhering to medication regimens more difficult1
– They may have physical disabilities, such as poor vision or
osteoarthritis, that may make opening medication
packages, reading directions, or effectively operating
medication delivery devices difficult1
– The presence of comorbidities may increase cognitive
effects and physical difficulties as well as require multiple
medications that may decrease adherence1
– COPD itself may affect cognition negatively, particularly in
the elderly2,3
– Elderly1
• Have more comorbidities
• Disorders such as those of the cardiovascular and musculoskeletal
systems (cachexia, muscle dysfunction, osteoporosis) and
psychological disorders (depression and/or anxiety) are common in
COPD patients, and can complicate treatment
– Twenty-five percent of those over age 65 years suffer from 2 of the 5
most common chronic diseases (including COPD) and 10% have 3 or
more; in those 75 years and older, those figures rise to 40% and 25%,
respectively2
1. Hanania NA, et al. Semin Respir Crit Care Med. 2010;31:596‐606. 2. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (Updated 2010). Available at http://www.goldcopd.org/uploads/users/files/GOLDReport_April112011.pdf. Accessed July 4, 2012. 1. Hanania NA, et al. Semin Respir Crit Care Med. 2010;31:596‐606. 2. Dodd JW, et al. Eur Respir J. 2010;35:913‐922. 3. Zhou G, et al. Dement Geriatr Cogn Dis Extra. 2012;2:219‐228.
55
COPD Medication Delivery Devices
COPD Medication Delivery Devices
•
• DPI
Number of different types of devices available
• Pressurized metered-dose inhaler (pMDI)
– Breath-actuated device designed to reduce difficulty encountered with
pMDIs; convenient, compact, portable device providing rapid medication
delivery; has dose counter, indicating amount of medication remaining;
some DPIs emit inspiratory-flow signals to prompt proper technique and
adherence
• Single- and multi-dose devices
– Requires the patient to generate sufficient inspiratory force in order to
deaggregate the powdered medication formulation
• The rate of ineffective inhalation due to inadequate peak inspiratory
flow (PIF) correlates with patient age and severity of airflow
obstruction
– Elderly patients with severe COPD may not be able to achieve
adequate inspiratory flow against the resistance of the device
– Requires PIF rate >30 L/min through the device
– Humidity or inappropriately blowing into the device may cause clumping
of powdered medication, resulting in ineffective delivery of medication
• Advantages include multiple dosing (≥100 doses/canister), shorter
administration time, compactness and portability of the device
• An important disadvantage is the requirement of a specific
inhalation technique, which requires adequate patient coordination
– Multiple steps involved
– Most common error is the failure to synchronize inhalation with
pMDI actuation
– 26% of patients demonstrate inadequate breath holding
– 19% have overly rapid inspiration leading to oropharyngeal
deposition instead of pulmonary delivery
• Even with proper technique, pMDIs deposit only 10%-20% of
labeled dose to the lungs, while much of the medication remains in
the mouth and oropharynx
– This can lead to adverse events
• Use of spacer devices eliminates need to coordinate inhalation with
actuation, but spacers are bulky and increase time for medication
delivery
Barrons R, et al. Am J Health Syst Pharm. 2011;68:1221‐1232.
56
57
Barrons R, et al. Am J Health Syst Pharm. 2011;68:1221‐1232.
9
58
COPD Medication Delivery Devices
COPD Medication Delivery Devices
• Soft Mist Inhaler
• Nebulizers
– Easiest for patients to use, requires minimal cognitive ability and no
hand-breath coordination, manual dexterity, or hand strength; visible
mist may give patients confidence in medication delivery
• Three types—compressor-driven jet nebulizer, conventional
ultrasonic nebulizer, and high efficiency vibrating mesh nebulizer
(quieter and allows for faster medication delivery)
• However, conventional ultrasonic nebulizers do not readily
aerosolize drug suspensions
– Relatively long duration of medication delivery, poor portability, need for
daily cleaning, and trouble and cost associated with proper maintenance
and replacement of nebulizers
• Cleaning requires disassembling nebulizer and soaking all
components in warm soapy water, rinsing, and air drying before
next use
• Device can last 6 months with proper care, while disposable units
last 2 weeks
– Advantages
• Compact1, portable1, multiple dosing2
• Propellant-free2
• Does not require high generation of inspiratory flow3
• High fine particle fraction2
• High lung deposition (reduced oropharyngeal deposition)2
– Disadvantages
• Requires coordination between actuation and inhalation2
• Requires a slow deep breath and a 10-second breath hold is
recommended2
1. Newman S. Eur Respir Rev. 2005;14:96, 102–108. 2. Hodder R. et al. Int J Chron Obstruct Pulmon Dis. 2009;4:381‐90. 3. Anderson P. Int J Chron Obstruct Pulmon Dis. 2006;1(3):251‐9.
59
Barrons R, et al. Am J Health Syst Pharm. 2011;68:1221‐1232.
COPD Medication Delivery Devices
COPD Medication Delivery Devices
ACCP/ACAAI Guidelines
• Vibrating mesh or vibrating plate nebulizers
• Summary of Randomized Controlled Trial Results
60
– Outpatient management of COPD with bronchodilators shows no
difference in pulmonary function response between delivery devices
– Increases in heart rate greater after administration of albuterol by
nebulizer than after administration by MDI
–
–
–
–
–
–
Higher lung deposition
Negligible residual volumes
Faster rate of nebulization
Battery operated
More portable than ultrasonic or jet nebulizers
Cost is comparable to ultrasonic nebulizers but much higher than
conventional jet nebulizers
– Must be cleaned regularly to prevent build-up of deposit and blockage of
apertures; can be challenging to disassemble and re-assemble for
cleaning
– Risk of overdosing using doses approved for use with jet nebulizers
(due to more efficient delivery of medication to the lung)
• Recommendations
– MDI (with or without spacer/holding chamber), nebulizer, and DPI are all
appropriate for delivery of inhaled bronchodilators. Quality of evidence:
good; net benefit: substantial; strength of recommendation: A
– Selection of an appropriate aerosol delivery device for inhaled
bronchodilators includes the patient’s ability to use the device correctly,
patient preference, the availability of the drug/device combination,
compatibility between the drug and the delivery device, the lack of time
or skills to properly instruct the patient in the use of the device or to
monitor its appropriate use, the cost of therapy, and the potential for
reimbursement. Quality of evidence: good; net benefit: substantial;
strength of recommendation: B
Dolovich MB, et al. Lancet. 2011;377:1032‐1042.
Dolovich MB, et al. Chest. 2005;127:335‐371.
61
62
Delivery Device Problems in
Select Populations
Delivery Device Problems in
Select Populations
• Physical issues (eg, arthritis, visual problems), the presence of multiple comorbidities, and cognitive issues may compromise a patient’s ability to use a delivery device effectively1
• Deficiencies in inhaler device technique and adherence to treatment regimen may lead to suboptimal health outcomes in COPD patients2
• DPIs require less coordination, but the patient must be able to
generate a certain minimum PIF rate (> 30 L/min) through the
resistance of the device that some older patients may not be able to
achieve1,2
– PIF rates decline with age1
– Evidence also suggests that up to 40% of patients aged > 65
years do not use DPIs correctly3
– Effects of incorrect use of DPIs
• Chronic cough, wheezing, and poorer health-related QOL
associated with incorrect inhalation technique in patients with
asthma4
– User technique, particle size, and type of delivery device affect the efficacy of inhaled medications1
– Evidence indicates that only 36% of elderly patients use an MDI properly1
• Technique is affected by cognitive impairment and physical disability1
• Can be difficult to coordinate actuation and inhalation3
• Use of a large volume spacer (LVS) can improve the patient’s ability to use this device1
1. Nazir, SA, et al. Drugs Aging. 2009;26:813‐831. 2. Barrons R, et al. Am J Health Syst Pharm. 2011;68:1221‐1232. 3. Gelberg J, et al. Drugs Aging. 2010;27:367‐375. 4. Lavorini F, et al. Respir Med. 2008;102:593‐604.
64
1. Nazir, SA, et al. Drugs Aging. 2009;26:813‐831. 2. Barrons R, et al. Am J Health Syst Pharm. 2011;68:1221‐1232. 3. Lavorini F, et al. Respir Med. 2008;102:593‐604.
63
10
Use of Nebulizers in
Subgroups of Patients
Efficacy and Safety of Maintenance Therapy
• Nebulizers may be preferable in certain subgroups of patients
– Elderly1
– Those with severe disease and frequent exacerbations1
– Those with physical and/or cognitive limitations1
– Those who fail to respond satisfactorily to treatment with
hand-held inhalers despite adequate instruction2,3
– Financial issues and patient preferences that enhance
adherence may favor nebulized therapy over other inhaler
devices4
• Nebulized medications are a good option for sicker, frailer
elderly patients, and those with cognitive problems1
1. Nazir SA, et al. Drugs Aging. 2009;26:813‐831. 2. British Thoracic Society Guidelines for the Management of Chronic Obstructive Pulmonary Disease, Thorax. 1997; 52(Suppl.5): S1‐S26. 3. NICE Guidelines 2010. Available at http://www.nice.org.uk/nicemedia/live/13029/49425/49425.pdf. Accessed September 21, 2012. 4. Dhand R, et al. COPD. 2012;9:58‐72.
• Nebulized formoterol vs placebo as add-on therapy to
tiotropium bromide in COPD patients
– At 6 weeks, FEV1 AUC significantly greater in formoterol
group than placebo (1.57 vs 1.38 L [P<.0001])1
– Other lung function measures also improved—FEV1,
forced vital capacity (FVC), and post-dose IC at day 1;
these were maintained through week 61
– Dyspnea also improved after 6 weeks to both a statistically
and clinically significant extent2,3
– AEs occurred in 37% of formoterol group vs 51% of
placebo group; the most common AEs in the formoterol
group were acute bronchitis (3.8%), COPD exacerbation
(2.6%), and dyspnea (2.6%)1
1. Hanania NA, et al. Drugs. 2009;69:1205‐1216. 2. Tashkin DP, et al. Respir Med. 2008;102:479‐487. 3. Tashkin DP, et al. Adv Ther. 66
2009;26:1024‐1034. 65
Efficacy and Safety of Maintenance Therapy
Safety of Long-Term Use of LABAs in COPD
• Nebulized formoterol, 12-month open-label trial
• Review of clinical efficacy and safety of nebulized
formoterol in COPD1,2
– 569 subjects with COPD received twice daily 20 μg formoterol inhalation
solution for nebulization or 12 μg formoterol fumarate DPI for 52 weeks
– Adverse effects (AEs) and safety profile similar between treatment groups
• AEs experienced by 73% in nebulizer group and 78% in DPI group
– Majority of AEs were mild to moderate in severity and unrelated
to treatment
• Exacerbation experienced by 15.8% of nebulizer group and 17.9% of
DPI group
• No clinically important changes in vital signs and no treatment-related
increases in cardiac arrhythmias, heart rate, or QTc prolongation
• Death occurred in 1.3% and more than 1 serious AE occurred in 16.2%
of nebulizer group, compared with 1.9% and 17.9% of DPI group,
respectively
– 12-week and 1-year studies reveal AEs similar to placebo
and formoterol DPI
• Indacaterol vs formoterol + budesonide or salmeterol +
fluticasone3
– Meta-analysis indicated indacaterol 150 ug* and 300 ug*
were comparable to formoterol + budesonide and
salmeterol + fluticasone for measures of lung function
health status and to salmeterol + fluticasone for
breathlessness
*FDA‐approved indacaterol dose is 75 ug once daily for COPD; 150 ug and 300 ug doses are Donohue JF, et al. Ther Adv Respir Dis. 2008;2:199‐208.
not approved in the United States.
67
68
1. Gross NJ, et al. Respir Med. 2008;102:189‐197. 2. Gross NJ, et al. Int J COPD. 2010;5:223‐232. 3. Cope S, et al. Int J COPD. 2011;6:329‐344.
Patient and Caregiver Training
and Education
Strategies for Improving Adherence
and Disease Control
•
• Critical factor in appropriate use of inhalers1,2,3
– Evidence indicates that teaching interventions substantially
increase the likelihood of proper inhaler use4
– Physicians should review patients’ inhaler technique regularly to
ensure that adequate amounts of medication are being
received2,5,6
– Education of caregivers is important as well, as many patients
rely on caregivers
– Self-management education has been associated with a
reduction in hospital admission, with no indication of adverse
effects7
• Odds ratio, 0.64; 95% confidence interval, 0.47 to 0.89
– Training of the patient in the use of inhaler devices often is
poorly addressed8
Use of the appropriate device tailored to the needs of the individual
patient
– Improves patient adherence and ability of patient to use the inhaler
correctly, thereby increasing the likelihood of achieving optimal
outcomes1
– Cost considerations may play a role as well1
• Medications administered using pMDI or DPI devices require
Medicare Part D
• Medicare Part B covers 80% of the cost of nebulizer equipment
and medication, which may make it the more affordable option
– Patient preference should be considered as well1,2
• Survey of 82 patients using nebulizers found that adherence
was high, and reported adverse effects minor and infrequent;
patients felt the benefits of the nebulizer outweighed the
disadvantages3
1. Fromer L, et al. Postgrad Med. 2010;122:83‐93. 2. Gelberg J, et al. Drugs Aging. 2010;27:367‐375. 3. Lareau SC, et al. J Am Acad Nurse Pract. 2012;24:113‐120. 4. Barrons R, et al. Am J Health Syst Pharm. 2011;68:1221‐1232. 5. Broeders
MEAC, et al. Prim Care Respir J. 2009;18:76‐82. 6. Melani AS. Acta Biomed. 2007;78:233‐245. 7. Effing T, et al. Cochrane Database Syst Rev. 2007 Oct 17;(4): CD002990. 8. Lavorini FM et al. Prim Care Respir J. 2010;19:335‐341. 1. Barrons R, et al. Am J Health Syst Pharm. 2011;68:1221‐1232. 2. Leidy NK, et al. Value Health. 2006;9:394‐401. 3. Barta SK, et 69
al. Respir Med. 2002;96:375‐381.
11
70
?
Polling Question
Conclusions
• COPD is a chronic, progressive disease
• Proper management of the disease can reduce acute
exacerbations, hospitalizations, and symptoms, and improve
QOL for patients
• Maintenance therapy is underutilized overall
• Some populations of patients, such as the elderly, cognitively
impaired, or physically disabled, may have difficulty using
maintenance medication delivery devices, even when
maintenance therapy is prescribed, and thus may receive less
than optimal amounts of medication
• Failure to use maintenance therapy appropriately may result
in increased acute exacerbations, hospitalizations, and costs
• Careful consideration of patient factors in selecting medication
and delivery devices can improve patient outcomes
In the future, how often will you prescribe LABAs
for maintenance therapy for your COPD patients?
1.
2.
3.
4.
Always
Usually
Sometimes
Never
71
Polling Question
72
?
?
Polling Question
How confident do you feel about selecting an appropriate LABA and delivery device for maintenance therapy for your patients based on their individual characteristics? How confident do you feel about your ability to instruct patients in the use of a dry powder inhaler (DPI) for maintenance therapy?
1.
2.
3.
4.
1.
2.
3.
4.
Very confident
Somewhat confident
Not very confident
Not confident at all
Very confident
Somewhat confident
Not very confident
Not confident at all
73
Polling Question
74
?
Questions & Answers
In the future, in elderly patients with cognitive problems and/or physical disabilities, what will you prescribe for maintenance therapy? ?
1. I will not prescribe therapy for these patients
2. I will have them use a SABA for rescue therapy as needed rather than a LABA for maintenance
3. I will prescribe a LABA using a breath‐activated inhaler for these patients and a SABA for rescue therapy as needed
4. I will prescribe a LABA / ICS fixed dose combination
5. I will prescribe a LABA using a nebulizer for these patients and a SABA for rescue therapy as needed
75
12