G S K s l i d e k i t f o r d i s t r i b u t i o n – B E / S F C / 0 0 0 5 / 1 2 “ “ How your approach in COPD How your approach in COPD might change in 2012” might change in 2012” INTRODUCTION INTRODUCTION GOLD 2007 GOLD 2007 CAT (COPD Assessment Test) CAT (COPD Assessment Test) HEED study HEED study ECLIPSE study ECLIPSE study GOLD 2012 GOLD 2012 POSITION OF COMBINATION THERAPY POSITION OF COMBINATION THERAPY CONCLUSION CONCLUSION
48
Embed
GSK slidekit for distribution –BE/SFC/0005/12 “How your approach in COPD might change in 2012” INTRODUCTION INTRODUCTION GOLD 2007 GOLD 2007 CAT (COPD.
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
GS
K slidekit for distribution –B
E/S
FC
/0005/12
““How your approach in COPD might How your approach in COPD might change in 2012”change in 2012”
POSITION OF COMBINATION THERAPYPOSITION OF COMBINATION THERAPY
CONCLUSIONCONCLUSION
““How your approach in COPD might How your approach in COPD might change in 2012”change in 2012”
GS
K slidekit for distribution –B
E/S
FC
/0005/12
Health status, FEVHealth status, FEV1 1 and GOLD stage:and GOLD stage:
Staging by FEVStaging by FEV11 neglects patient outcomes neglects patient outcomes
Jones P. Thorax 2001;56:880-887.
0
20
40
60
80
100
10 20 30 40 50 60 70 80 90
Upper limit
of normal
SGRQ score
Stage 4 Stage 3 Stage 2
FEV1 (% predicted)
Breathless walking on
level ground
Breathless walking on
level ground
r =–0.23P<0.0001
Lung function measurements do not reflect the impact of COPD
GS
K slidekit for distribution –B
E/S
FC
/0005/12
Medical Research Council (mMRC) Medical Research Council (mMRC) Dyspnea ScoreDyspnea Score
mMRC 4: I am to breathless to leave the house…; mMRC 3: I stop for breath after walking about 100 yards…; mMRC 2: I walk slower than other people…; mMRC 1: Short of breath when hurrying; mMRC 0: Breathless with strenuous exercise
0%10%20%30%40%50%60%70%80%90%
100%
Mild Moderate Severe Very Severe mMRC 4 mMRC 3 mMRC2 mMRC1 mMRC 0
Adapted from Jones P. et al, ERJ 2011; 34: 29-35
Airflow limitation: (FEV1)
Dyspnea was defined as a score of 2 or higher on mMRC scale
GS
K slidekit for distribution –B
E/S
FC
/0005/12
AimsAims of the COPD Assessment Test (CAT) of the COPD Assessment Test (CAT)
CATCAT: :
a patient-completed questionnairea patient-completed questionnaire
a short, simple and reliable test:a short, simple and reliable test:
To improve the assessment of COPD To improve the assessment of COPD patientspatients
To grade the impact of COPD on health To grade the impact of COPD on health status.status.
Jones P. et al, ERJ 2009; 34: 648-654.
GS
K slidekit for distribution –B
E/S
FC
/0005/12
COPD Assessment Test (CAT)COPD Assessment Test (CAT)
Scoring range 0–40
✗✗✗
✗
✗✗
✗✗
1
1
2
4
3
4
2
5
22Jones P. et al, ERJ 2009; 34: 648-654.
GS
K slidekit for distribution –B
E/S
FC
/0005/12
Impact of COPD on daily lifeImpact of COPD on daily life
40
Light
Moderate
Important
Very important
30
20
10
CAT score
www.CATestonline.org
GS
K slidekit for distribution –B
E/S
FC
/0005/12
CAT: correlation with SGRQCAT: correlation with SGRQ
POSITION OF COMBINATION THERAPYPOSITION OF COMBINATION THERAPY
CONCLUSIONCONCLUSION
““How your approach in COPD might How your approach in COPD might change in 2012”change in 2012”
GS
K slidekit for distribution –B
E/S
FC
/0005/12
HEED study: Health related quality HEED study: Health related quality of life in European COPD patientsof life in European COPD patients
A large cross-sectional observational study to evaluate A large cross-sectional observational study to evaluate health status in patients with COPD health status in patients with COPD inin primary careprimary care..
COPD patients:COPD patients:– Age: 40-80 yearsAge: 40-80 years– COPD: all severitiesCOPD: all severities– Current or ex-smokers with a smoking history of Current or ex-smokers with a smoking history of ≥ 10 pack-≥ 10 pack-
yearsyears
7 Countries: Belgium, France, Germany, Italy, the 7 Countries: Belgium, France, Germany, Italy, the Netherlands, Spain and UK.Netherlands, Spain and UK.
Jones P. et al, Resp Medicine 2011.
GS
K slidekit for distribution –B
E/S
FC
/0005/12
European COPD Quality of Life SurveyEuropean COPD Quality of Life Survey
Jones P. et al, Resp Medicine 2011.
Total: n = 1.787
GS
K slidekit for distribution –B
E/S
FC
/0005/12
European COPD Quality of Life Survey: SGRQEuropean COPD Quality of Life Survey: SGRQ
Jones P. et al, Resp Medicine 2011.
GS
K slidekit for distribution –B
E/S
FC
/0005/12
European COPD Quality of Life Survey: CATEuropean COPD Quality of Life Survey: CAT
Jones P., Brusselle G. et al, ERJ 2011.
GS
K slidekit for distribution –B
E/S
FC
/0005/12
European COPD Quality of Life Survey: European COPD Quality of Life Survey: CAT correlation with SGRQCAT correlation with SGRQ
r=0.80* *P<0.0001
Jones P., Brusselle G. et al, ERJ 2011.*Jones PW et al. Eur Respir J 2009
Pulmonary plethysmography; Body composition; Fat-free mass; Exercise capacity; Induced sputum; Health status (SGRQ,BODE)(SGRQ,BODE); Dyspnoea
GOLD stage II (FEV1 50–80% pred.)
GOLD stage IV (FEV1 <30% pred.)
GOLD stage III (FEV1 30–50% pred.)
21
80
CO
PD
s
ub
jec
ts**
343 smoking controls
223 non-smoking controls56
6 c
on
tro
l s
ub
jec
ts**P
lan
ned
R
ecru
itm
ent
0 3 6 12 18 24 30 36
Months0 3 6 12 18 24 30 36
An
alys
is
FSFV* Dec 19 2005
LSLV* Feb 19 2010
46 Centres;12 Countries
Year 1 and 3 Visits captured:• Chest computed tomography
Year 3 visit captured: • Depression; Fatigue
GS
K slidekit for distribution –B
E/S
FC
/0005/12
An exacerbation of COPD is:
“an acute event characterized by a worsening of the patient’s respiratory symptoms that is beyond normal day-to-day
variations and leads to a change in medication.”
Definition of COPD exacerbationDefinition of COPD exacerbation according to GOLD guidelinesaccording to GOLD guidelines
www.goldcopd.org
GS
K slidekit for distribution –B
E/S
FC
/0005/12
Susceptibility to Exacerbation in Susceptibility to Exacerbation in Chronic Obstructive Pulmonary Chronic Obstructive Pulmonary
DiseaseDiseaseJohn R. Hurst, Jørgen Vestbo, Antonio John R. Hurst, Jørgen Vestbo, Antonio
Anzueto, Nicholas Locantore, Hana Anzueto, Nicholas Locantore, Hana Mϋllerova, Ruth Tal-Singer, Bruce Mϋllerova, Ruth Tal-Singer, Bruce
Miller, David A. Lomas, Alvar Agusti, Miller, David A. Lomas, Alvar Agusti, William MacNee, Peter Calverley, William MacNee, Peter Calverley,
Stephen Rennard, Emiel F.M. Wouters Stephen Rennard, Emiel F.M. Wouters and Jadwiga A. Wedzichaand Jadwiga A. Wedzicha
New England Journal of New England Journal of MedicineMedicine
2010;363:1128-382010;363:1128-38
The ‘frequent exacerbator The ‘frequent exacerbator phenotype’: ECLIPSEphenotype’: ECLIPSE
Hurst JR, et al. N Engl J Med. 2010;363:1128-38.
GS
K slidekit for distribution –B
E/S
FC
/0005/12
BackgroundBackground– Exacerbations of COPD are a major part of the natural history of Exacerbations of COPD are a major part of the natural history of
COPD:COPD:
Accelerate decline in lung functionAccelerate decline in lung function
Reduce physical activity and QoLReduce physical activity and QoL
Increase risk of hospitalization and deathIncrease risk of hospitalization and death
The ‘frequent exacerbator phenotype’: The ‘frequent exacerbator phenotype’: ECLIPSE: ECLIPSE: IntroductionIntroduction
Hurst JR, et al. N Engl J Med. 2010;363:1128-38
Is the most reliable predictor of exacerbations in an individual patient a history of prior exacerbations?
29
GS
K slidekit for distribution –B
E/S
FC
/0005/12
The ‘frequent exacerbator phenotype’: ECLIPSEThe ‘frequent exacerbator phenotype’: ECLIPSEFrequency/Severity of Exacerbations by GOLD stage (1)Frequency/Severity of Exacerbations by GOLD stage (1)
p<0.01
Hospitalised for exacerbation in yr 1 Frequent exacerbations (2 or more)
ECLIPSE 1 year data Hurst et al. N Engl J Med 2010
Exacerbations are more frequent and more severe with increasing COPD severity
What are the predictors of exacerbation frequency?
GS
K slidekit for distribution –B
E/S
FC
/0005/12
The ‘frequent exacerbator phenotype’: The ‘frequent exacerbator phenotype’: ECLIPSE: ECLIPSE: Stability of the Exacerbator PhenotypeStability of the Exacerbator Phenotype
74% of patients having no exacerbations in Years 1 and Year 2 had no exacerbations in Year 3
Hurst JR, et al. N Engl J Med. 2010;363:1128-38.ECLIPSE 3 year data
71% of Frequent Exacerbators in Year 1 and Year 2 were Frequent Exacerbators in Year 3
GS
K slidekit for distribution –B
E/S
FC
/0005/12
ECLIPSE and HEED confirm ECLIPSE and HEED confirm – Disease severity (breathlessness, exercise capacity, Disease severity (breathlessness, exercise capacity,
exacerbations, health status degradation) increases with exacerbations, health status degradation) increases with GOLD stageGOLD stage
– FEV1 poorly related with other parameters FEV1 poorly related with other parameters – COPD is highly heterogeneousCOPD is highly heterogeneous– Within GOLD stage there is Within GOLD stage there is substantialsubstantial variation in: variation in:
BreathlessnessBreathlessness
Exercise capacity Exercise capacity
Exacerbation frequencyExacerbation frequency
Health statusHealth status
Conclusions (1)Conclusions (1)
Agusti A, et al. Resp Res. 2010;11:122
“Airflow limitation alone does not provide an accurate measure of disease severity or activity”
32
New GOLD guidelines must include other parameters: QoL, symptoms and exacerbation rate
GS
K slidekit for distribution –B
E/S
FC
/0005/12
Conclusions (2) Conclusions (2)
ECLIPSE confirms ECLIPSE confirms
Exacerbations become more frequent and more severe Exacerbations become more frequent and more severe as COPD severity increasesas COPD severity increases
Frequent exacerbator is an independent disease Frequent exacerbator is an independent disease phenotypephenotype– That can be identified by patient self-report about That can be identified by patient self-report about
previous exacerbationsprevious exacerbations– Stable over time (3 yrs)Stable over time (3 yrs)– Patients with moderate COPD may be frequent Patients with moderate COPD may be frequent
exacerbators (22%)exacerbators (22%)
Exacerbation in prior year is the best predictor of occurrence of exacerbation
Exacerbation rate must be integrated in GOLD guidelines
*p < 0.001 vs placebo; †p < 0.001 vs SALM and FPCalverley et al. NEJM 2007
GS
K slidekit for distribution –B
E/S
FC
/0005/12
0.029%SFC vs FP
0.00212%SFC vs salmeterol
<0.00125%SFC vs placebo
TORCH: SFC significantly reduces TORCH: SFC significantly reduces exacerbationsexacerbations over 3 years over 3 years
p-valueTreatment effect
0
0.2
0.4
0.6
0.8
1.0
1.2
Placebo
Annualis
ed e
xace
rbati
on r
ate
Salmeterol FP SFC
25% (p<0.001)
1.13
0.97 0.930.85
Calverley N Eng J Med 2007
GS
K slidekit for distribution –B
E/S
FC
/0005/12
0.0213%SFC vs FP
<0.00129%SFC vs salmeterol
<0.00143%SFC vs placebo
p-valueTreatment effect
TORCH: SFC reduces rate of TORCH: SFC reduces rate of exacerbations exacerbations requiring systemic corticosteroidsrequiring systemic corticosteroids over 3 over 3
yearsyearsA
nnualis
ed e
xace
rbati
on r
ate
–0.05
0.15
0.35
0.55
0.75
0.95
1.15
Placebo Salmeterol FP SFC
43% (p<0.001)
0.80
0.64
0.520.46
Calverley N Eng J Med 2007
GS
K slidekit for distribution –B
E/S
FC
/0005/12
TORCH: SFC reduces the rate of severe TORCH: SFC reduces the rate of severe exacerbations exacerbations requiring hospitalisationrequiring hospitalisation over 3 years over 3 years