Feature Story

44 Pages·2014·6.24 MB·English

154789 COPD LHP Issue Spring 5/28/14 2:59 PM Page 1
VOLUME 5 I NUMBER 2 I 2014
Lung Health Professional
TM
M A G A Z I N E
The Past Decade of Advances
in the Pharmacological
Treatment of COPD
The COPDGene®Study: Past,
Present and Future
New Open Access COPD
Journal Launched and
Available
Engage Our Experts at the
COPD Pocket Consultant
Guide Community Website
Respiratory Therapists Seize
the Day
COPD Management in
Primary Care: The Past Ten
Years
COPD Foundation’s Medical
and Scientific Advisory
Committee (MASAC) and
Clinical Advisory Committee
(CAC) Resolution
Feature Story:
COPD Management in Primary Care: The Past Ten Years
Page 31
154789 COPD LHP Issue Spring 5/28/14 2:59 PM Page 2
Letter from the Managing Editor:
Katelyn Turner
T
here has already been so much exciting Pulmonary Diseases: Journal of the COPD
activity and news for the COPD Foundation, discusses its launch and
Foundation, and it’s only our second issue inaugural issue which is accessible online at
of the year. In this issue, we continue to http://journal.copdfoundation.org. It features
feature 10-year anniversary articles that review articles that discuss progress made in
commemorate the past decade of progress for COPD over the past decade, and original
the COPD Foundation and COPD research articles. To read more about the
community. On behalf of the COPD Journal, please read her article on page 22.
Foundation, I want to thank all of our authors
who make Lung Health Professionalpossible, COPD Pocket Consultant Guide Community
and I want to thank all of you for your Website:
support. I encourage you to share COPD
Our Director of Education, Scott Cerreta, BS,
Foundation resources with your colleagues
RRT, contributed this piece that discusses the
and patients—we are continuously receiving
COPD Foundation Pocket Consultant Guide
wonderful articles and are grateful to all who
(PCG) for the Diagnosis and Management of
make it happen.
COPD—designed to be a practical tool to
Feature on a Decade of Advances in the assist practicing clinicians in managing the
Pharmacological Treatment of COPD: diagnosis and treatment of COPD patients.
The PCG Online Community Website was
I am grateful to Dr. Kristina Bailey’s launched in February, and allows physicians
contribution of our feature piece for this issue. and other healthcare professionals to interact
She reviews new COPD drugs with their with COPD experts. You can read all about
mechanism of action, dosage, and side this on page 25.
affects, also summarizing the data available
from clinical trials in which patients are most COPD Management in Primary Care:
likely to benefit. You can find this article on The Past Ten Years
page 6.
Drs. Alan G. Kaplan and Barbara Yawn
The COPDGene®Study: An Important Update: contributed this important piece that
discusses how primary care has made
Dr. Craig Hersh contributed this article that progress in the past 10 years in improving the
discusses the history of the pivotal diagnosis, management and lives of individuals
COPDGene® Study, as well as its current living with COPD. This article is on page 31.
status and what he sees for the future. He
As always, please feel free to send me your
writes about the importance of this study and
suggestions for topics for future issues of
why all members of the COPD community
LHP. I welcome your input.
should be excited about it. You can find his
article on page 11.
Best,
Katelyn Turner
New Open Access COPD Journal Launched
and Available:
Please send suggestions to:
[email protected]
Cathy Carlomagno, Production Editor for the
COPD Foundation’s Chronic Obstructive
Lung Health Professional magazine is published 4 times annually and is available from the
COPD Foundation free of charge. If you would like to be added as a subscriber, please email
Katelyn Turner at [email protected] or call the C.O.P.D. Information Line
1-866-316-COPD (2673).
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Important Safety Information
PROLASTIN®-C (alpha-proteinase inhibitor [human]) is indicated for The most common drug related adverse reactions during clinical trials
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due to defi ciency of alpha-proteinase inhibitor (alpha-antitrypsin pruritus. The most serious adverse reaction observed during clinical studies
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References: 1. Data on fi le, PROLASTIN DIRECT program. 2. Campos MA,
therapy for lung disease in patients in whom severe alpha-PI defi ciency
1 Alazemi S, Zhang G, Wanner A, Sandhaus RA. Effects of a disease
has not been established.
management program in individuals with alpha-1 antitrypsin defi ciency.
PROLASTIN-C may contain trace amounts of IgA. Patients with known COPD. 2009;6:31-40. 3. Data on fi le, Grifols.
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PROLASTIN®-C ----------------CONTRAINDICATIONS--------------
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IgA are at greater risk of developing severe
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information for PROLASTIN-C.
and may contain infectious agents, e.g.,
viruses and, theoretically, the Creutzfeldt-
PROLASTIN®-C (Alpha -Proteinase Inhibitor
1
Jakob disease agent.
[Human]) Lyophilized Preparation
----------------ADVERSE REACTIONS--------------
For Intravenous Use Only
The most common drug related adverse
Initial U.S. Approval: 1987
reactions during clinical trials in (cid:31) 1% of
subjects were chills, malaise, headache, rash,
-------------INDICATIONS AND USAGE-----------
hot flush, and pruritus.
PROLASTIN-C is an alpha -proteinase inhibitor
1 To report SUSPECTED ADVERSE REACTIONS,
that is indicated for chronic augmentation and
contact Grifols Therapeutics Inc. at 1-800-
maintenance therapy in adults with emphysema
520-2807 or FDA at 1-800-FDA-1088 or
due to deficiency of alpha -proteinase inhibitor
1 www.fda.gov/medwatch.
(alpha -antitrypsin deficiency). The effect of
1
---------USE IN SPECIFIC POPULATIONS-------
augmentation therapy with any alpha -
1
proteinase inhibitor (Alpha -PI) on pulmonary (cid:55) (cid:23)(cid:44)(cid:32)(cid:34)(cid:41)(cid:28)(cid:41)(cid:30)(cid:51)(cid:14)(cid:1)(cid:21)(cid:42)(cid:1)(cid:35)(cid:47)(cid:40)(cid:28)(cid:41)(cid:1)(cid:42)(cid:44)(cid:1)(cid:28)(cid:41)(cid:36)(cid:40)(cid:28)(cid:39)(cid:1)(cid:31)(cid:28)(cid:46)(cid:28)(cid:7)(cid:1)(cid:27)(cid:45)(cid:32)
1
exacerbations and on the progression of only if clearly needed.
emphysema in alpha -antitrypsin deficiency has
1
not been demonstrated in randomized,
controlled clinical trials. PROLASTIN-C is not
indicated as therapy for lung disease in patients
in whom severe Alpha -PI deficiency has not Grifols Therapeutics Inc.
1
(cid:24)(cid:32)(cid:45)(cid:32)(cid:28)(cid:44)(cid:30)(cid:35)(cid:1)(cid:26)(cid:44)(cid:36)(cid:28)(cid:41)(cid:34)(cid:39)(cid:32)(cid:1)(cid:23)(cid:28)(cid:44)(cid:38)(cid:5)(cid:1)(cid:21)(cid:16)(cid:1)(cid:10)(cid:11)(cid:11)(cid:8)(cid:13)(cid:1)(cid:27)(cid:25)(cid:15) 08941114-BS
been established. (cid:27)(cid:7)(cid:25)(cid:7)(cid:1)(cid:20)(cid:36)(cid:30)(cid:32)(cid:41)(cid:45)(cid:32)(cid:1)(cid:21)(cid:42)(cid:7)(cid:1)(cid:9)(cid:12)(cid:11)(cid:9) Revised:June2012
154789 COPD LHP Issue Spring 5/28/14 2:59 PM Page 5
Lung Health Professional
TM
VOLUME 5 I NUMBER 2 I 2014
M A G A Z I N E
Table of Contents
VOLUME 5 INUMBER 2 I 2014
Lung Health ProfessionalTM
MAGAZINE
Page
TiTnhr eteha Petm aPsehtn aDtr moecfa aCcdOoelPo oDgfi cAadlvances
PThrees CenOtP aDnGd eFnuetu®rSetudy: Past,
NJAoveuawriln aOablpl eLea nu Ancccheesds a CnOdPD Letter from the Managing Editor 2
CEGRthneOuegsi PdpDaDeigar aeyCPt ooOomcruykr meT Ethu xCenprioetaynrp tsWissu tealstbta Ssnthietteeiz e Katelyn Turner
CPYreOiamPrDasr yM Caanraeg:e Tmhee nPta inst Ten
CaCC(CnOoliAdnmP CiScDm)ac RliFi teAtoeendsuetovnif il(idsucMaot AitAroiyodSn nvCAi’soCsom )Mr aymendidtitceael The Past Decade of Advances in the Pharmacological Treatment of COPD* 6
Kristina Bailey, MD
Feature Story:
CPaOgPeD 3 1M anagement in Primary Care: The Past Ten Years The COPDGene® Study: Past, Present and Future* 11
Craig P. Hersh, MD, MPH, George R. Washko, MD, MS, Elizabeth A. Regan, MD, PhD
Managing Editor: New Open Access COPD Journal Launched and Available 22
Katelyn Turner Cathy Carlomagno
COPD Foundation
Engage in Our Experts at the COPD Pocket Consultant Guide Community 25
Guest Editor:
Website
Byron Thomashow, MD
Scott Cerreta, BS, RRT
Columbia
NewYork Presbyterian
Respiratory Therapists Seize the Day: Growing Awareness + 26
Contributors: Health Care Reform = Opportunities to do More for Those With COPD*
Thomas Kallstrom, MBA, RRT, FAARC
Elisha Malanga
COPD Foundation
COPD Management in Primary Care: The Past Ten Years* 31
Katya Hernandez
Alan G. Kaplan, MD, CCFP (EM), FCFP, Barbara P. Yawn, MD, MSc, FAAFP
Original Impressions, Inc.
COPD Foundation’s Medical and Scientific Advisory Committee 38
(MASAC) and Clinical Advisory Committee (CAC) Resolution
*This article is special for the COPD Foundation's 10-year anniversary.
No part of this magazine may be reproduced in any form by any means without prior written permission of the
COPD Foundation. The contents of this magazine are not intended to provide personal medical advice, which
should be obtained directly from a physician. Editorial and advertising opinions expressed herein do not
necessarily reflect those of the COPD Foundation. Models are for illustrative purposes only. The COPD
Foundation, this magazine, their employees, officers, Board members, writers staff and any contributors do not
endorse or make representations regarding any clinical trial ad or product featured, mentioned, or advertised in
this magazine or any brochure that may have been included with the mailing of this magazine. Nothing in this
magazine or included in the mailing of this magazine constitutes medical advice. Please consult with your
physician regarding any medical decisions.
Letters to the Editor: Lung Health Professional Magazinewould like to hear from you. Send letters to 3300 Ponce
de Leon Blvd., Miami, FL, 33134 or email us at [email protected]
Advertising: For more information on advertising, please contact [email protected].
154789 COPD LHP Issue Spring 5/28/14 2:59 PM Page 6
The Past Decade of Advances in the Pharmacological
Treatment of COPD
Kristina Bailey, MD COPD is characterized by persistent airflow loss of appetite (2%), weight loss (5-10%).
Assistant Professor limitation due to chronic inflammation of the
Contraindications:Moderate to severe hepatic
Department of Internal lower airways. The symptoms of shortness of
impairment (Child-Pugh class B or C)
Medicine breath, cough and sputum production can
Pulmonary, Critical Care, increase during exacerbations of COPD. Data from clinical trials:In a randomized,
Sleep and Allergy Appropriate pharmacological therapy of placebo controlled study over 1 year, there was
Nebraska Medical Center COPD can reduce symptoms, the frequency an increase in FEV1 of 48ml in the roflumilast
Omaha, NE and severity of exacerbations and improve patients compared to control. There was also a
exercise tolerance. Despite these decrease in exacerbations of 17% in the
advancements, there is a desperate need for roflumilast group.[1]A subsequent post-hoc
new drugs to treat COPD. The available drugs analysis showed that a subset of COPD
do little to slow the progression of COPD. patients with chronic bronchitis were most
Developing new COPD drugs is often a likely to benefit independent of whether they
difficult process, due to the fact that there are were treated with inhaled corticosteroids.[2]
not good animal models and long-term
COPD patients most likely to benefit:Patients
studies are typically required to see
with GOLD stage 3-4 disease (FEV1 < 50%)
differences with treatment.
with a history of exacerbations and chronic
bronchitis (chronic cough and sputum
In this article, we will review each new drug
production). It can be used in combination
along with its mechanism of action, dosage,
and side effects. We will also summarize the with long-acting β-agonists and inhaled
corticosteroids.
data available from clinical trials and which
patients are most likely to benefit. In the last
Long-actingβ-agonists
10 years, there have been nine new drugs
Indacaterol
approved for COPD. Most represent new
combinations of known drugs, or a new
Mechanism of action:A long-acting (over 24
variation in an already available class of drugs.
hours) β-agonist, with a rapid (5 min) onset of
Only one drug represents a new class of
action.
medications, the phosphodieserase 4 (PDE4)
inhibitor, Roflumilast. Dose:One inhalation once daily
(75mcg/inhalation) in the USA, 150-300mcg
Phosphodiesterase 4 (PDE4) inhibitor in Europe.
Roflumilast
Side effects:Cough (7-24%) Headache (5%)
Mechanism of action:Roflumilast blocks PDE Contraindications:Hypersensitivity to
4, which is expressed in macrophages, indacaterol, not to be used for acute
neutrophils, CD8+ T-cells, and airway smooth exacerbations of COPD
muscle cells. PDE4 normally degrades cAMP.
Data from clinical trials: Indacaterol improves
By inhibiting PDE4, cAMP accumulates in the
trough FEV1 by 120-140 ml (with 75mcg) [3]
cells. The increase in cAMP is thought to
and 170 ml (with 300mcg) [4] after 12-weeks of
diminish inflammation and provide
therapy compared to control. It also shows a
bronchodilation.
greater increase in FEV1 compared to
Dose:500mcg orally once a day. formoterol [5][4] and salmeterol [6]. It was
Side effects:Nausea (5%), diarrhea (10%), equivalent to tiotroprium monotherapy [7]
This article is special for the COPD Foundation's 10-year anniversary.
6 LUNG HEALTH PROFESSIONAL MAGAZINE • VOLUME 5 I NUMBER 2 I 2014
154789 COPD LHP Issue Spring 5/28/14 2:59 PM Page 7
However, indacaterol does provide additional Data from clinical trials:Tiotroprium
bronchodilation when used in conjunction improves FEV1 and SGRQ status to a greater
with tiotroprium. [8]It also improves dyspnea extent than ipratroprium [12]. When
compared to control, and health-related tiotroprium is added to treatment with long
quality of life as measured by the St. George acting β-agonists and inhaled corticosteroids,
respiratory questionnaire [9]. the tiotroprium group maintains a higher
FEV1 , has improved health status and fewer
COPD patients most likely to benefit:
exacerbations. Tiotroprium may also may
Indacaterol can be used in COPD patients
improve dynamic hyperinflation and exercise
with moderate to severe disease. It has the endurance in patients with COPD [12]as well
additional benefit of once a day as respiratory muscle strength and oxygen
administration, which could benefit patients uptake after exercise [13]
that struggle with complex regimens.
Aclininium bromide
Arformoterol
Mechanism of action: Blockcade of the M3
Mechanism of action: Arfomoterol is the (R,R)
and M2 receptor. However, the half-life of
entantiomer of the long acting β-agonist inhibition of the M3 receptor is 6 times that of
formoterol. It is administered by nebulizer.
the M2 receptor.
Dose:15mcg/2ml nebulized twice a day Dose:One inhalation (400mcg) twice daily
Side effects:Chest pain (7%), diarrhea (6%) Side effects:Headache (7%), pharyngitis (6%),
Contraindications:Hypersensitivity to Contraindications:May worsen symptoms of
arfomoterol or racemic formoterol narrow-angle glaucoma, myasthenia gravis,
Data from clinical trials:Arformoterol has and prostatic hypertrophy.
been shown to improve trough FEV1 and Data from clinical trials:Aclinium bromide
dyspnea in moderate to severe COPD.[10]The induced larger increases in FEV1 than
bronchodilatory effect of arformoterol was
placebo [14, 15], and they were comparable to
similar to mono-therapy with tiotroprium, but those of tiotroprium [16].
there was additional benefit to using both
drugs together.[11] COPD patients most likely to benefit:
Moderate to severe COPD. The inhalation
COPD patients most likely to benefit:
device may be easier for patients with severe
Arfomoterol is useful for patients that have
COPD to use, because it has a lower
difficulty with using the traditional inhaled resistance than tiotroprium’s inhaler [12].
powder inhaler, or prefer nebulized medications.
Inhaled combination medications
Long Acting Anticholinergics
Tiotroprium In the last 10 years, there have been 2 new
inhaled corticosteroid/ long acting β-agonist
Mechanism of action:Tiotroprium is a long
combinations: Fluticasone/Vilanterol and
acting anti-cholinergic agent. It blocks
Mometesone/formoterol. There has also been
primarily the M3 receptor, which is
one combination of long acting
responsible for bronchodilation, over the M2
anticholinergic and long-acting β-agonist,
receptor, which is responsible for side effects
Umedclininum/vianterol.
such as tachycardia.
Fluticasone/Vilanterol
Dose:18mcg inhaled once a day
Side effects:Dry mouth (5-16%), upper Mechanism of action:Fluticasone is an
respiratory tract infection (41%), sinusitis (7-11%) inhaled corticosteroid with anti-inflammatory
and immunosuppressive properties.
Contraindications:Hypersensitivity to
Vilanterol is a long-acting β-agonist (24 hrs),
tiotroprium or ipratroprium. Tiotroprium may
which relaxes bronchial smooth muscle by
worsen the symptoms of narrow-angle
selective action on β2-agonist receptors
glaucoma, myastehenia gravis and prosthatic
hyperplasia. Dose:Fluticasone 100 mcg and vilanterol 25
7
154789 COPD LHP Issue Spring 5/28/14 2:59 PM Page 8
mcg one inhalation per day. Contraindications:Hypersensitivity to
umeclidinium, vilanterol
Side effects:Headache (7%), Nasopharyngitis
(9%), upper respiratory tract infection (7%), Data from clinical trials:
pneumonia (6%), oral candidiasis (5%). Umedclinium/vilanterol significantly
Contraindications:Hypersensitivity to improved FEV1 compared to placebo [20]or
fluticasone or vilanterol tiotroprium [21].
Data from clinical trials: COPD patients most likely to benefit:Patients
Fluticasone/Vilanterol improves trough FEV1 that prefer a once a day regimen.
compared to placebo in a group of patients
that included many current smokers[17]. It did Smoking cessation aids
not cause any increase in heart rate.[18]
Varencicline
COPD patients most likely to benefit:This is
a once a day preparation which may be Mechanism of action:Varencicline is a partial
particularly useful for patients that desire a agonist for the β4β2 nicotinic acetylcholine
simpler regimen. receptor. In other words, varencicline binds to
the receptor, and does not let nicotine bind.
Mometasone/formoterol
Dose:Varencicline should be started 1 week
Mechanism of action:Mometasone is an prior to the quit date. Then start 0.5mg each
inhaled corticosteroid and formoterol is a day for 3 days. Then 0.5mg twice a day for 4
long-acting β-agonist. days, then 1mg twice a day for up to 12 weeks.
Dose:Mometasone 100 mcg/ formoterol 5mcg Side effects: Nausea (30%), Vivid or unusual
per inhalation twice a day or 200 mcg/ dreams (13%), constipation (8%), Flatulence
formoterol 5mcg per inhalation twice a day (6%), vomiting (5%)
Side effects:Nasopharyngitis (5%), voice Contraindications:Patients need to be
disorder (4% to 5%), monitored closely for neuropsychiatric
symptoms, because Varencicline can increase
Contraindications:Hypersensitivity to
the risk of suicidal thoughts or actions.
mometasone, formoterol,
Data from clinical trials:Several randomized,
Data from clinical trials:Most clinical trials controlled clinical trials have shown that
were focused on asthma, but there are studies varenicline is superior to placebo [22-25]and
showing improvement in FEV1 in COPD sustained-release bupropion [23]for smoking
compared to control. There are also cessation.
improvements in quality of life and number of
exacerbations [19] COPD patients most likely to benefit:Those
that have made the decision that it is time to
Umedclinium/vilanterol stop smoking.
Mechanism of action: Umedclinium is a long Although our armamentarium of available
acting antimuscarinic (M3) blocker. Vilanterol drugs for COPD has increased over the past
is a long-acting selective β-agonist. 10 years, we still have a long way to go to have
good treatment options for all of our patients.
Dose:Umeclidinium 62.5 mcg and vilanterol
Advancement in the treatment of COPD will
25 mcg per inhalation once a day
require further understanding of the
pathophysiology of COPD, so that we can
Side effects:Pharyngitis (2%), lower
determine the best ways to target the
respiratory tract infection (1%)
underlying inflammation of the airways.
(Continued on page 10)
8 LUNG HEALTH PROFESSIONAL MAGAZINE • VOLUME 5 I NUMBER 2 I 2014
B:8.25”
T:8”
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154789 COPD LHP Issue Spring 5/28/14 2:59 PM Page 10
(Continued from page 8)
References
1. Calverley, P.M., et al., Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical
trials. Lancet, 2009. 374(9691): p. 685-94.
2. Rennard, S.I., et al., Reduction of exacerbations by the PDE4 inhibitor roflumilast--the importance of defining different
subsets of patients with COPD. Respir Res, 2011. 12: p. 18.
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10 LUNG HEALTH PROFESSIONAL MAGAZINE • VOLUME 5 I NUMBER 2 I 2014