Transcript Need for evidence-based guidelines

Meeting del Dipartimento ad Attività Integrata di Oncologia,
Ematologia e Patologie dell’Apparato Respiratorio
Villa Pineta, 16 Luglio 2011
Progetto ALICE
Airflow Limitation In patients with Cardiovascular Events
B. Beghé, A. Verduri, M. Bortolotti, P. Roversi
Progetto ALICE
 This is a cross-sectional study, investigating the
prevalence of Airflow Limitation in current or former
smokers with established ischemic heart disease
 The study will recruit 3000 patients across Europe
attending cardiology clinics
Background
 Airflow Limitation is a functional feature of COPD
 Middle-aged and older smokers develop COPD
 COPD is associated with co-morbidities
 Cardiovascular are more frequent
 COPD is often underdiagnosed and undertreated
Prevention of exacerbations of chronic obstructive
pulmonary diseases with tiotropium, a once-daily
inhaled anticholinergic bronchodilator: a randomized
trial.
Co-morbilità
Vascolari (compresa l’ipertensione)
Cardiache
64%
38%
Gastrointestinali
48%
Metaboliche o nutrizionali
47%
Muscolo scheletriche o connettivali
46%
Genito-urinarie
27%
Neurologiche
22%
Niewoehner et al, Ann Intern Med 2005;143:317-326
Role of co-morbidities in a cohort of patients
with COPD undergoing pulmonary rehabilitation
• 51% of the patients reported at least one chronic
comorbidity added to COPD.
• Metabolic (systemic hypertension, diabetes and/or
dyslipidaemia) and heart diseases (chronic heart
failure and/or coronary heart disease) were the most
frequently reported co-morbid combinations (61% and
24%, respectively)
Crisafulli E, et al.,Thorax 2008;63: 487-492.
What do COPD Patients Die From?
Normal
Restricted
GOLD 2
GOLD 3/4
0%
20%
COPD
40%
ASCVD
60%
80%
Lung Cancer
100%
Other
Mannino et al, ERJ, 2007
Cardiovascular mortality in COPD
For every 10% decrease in FEV1,
cardiovascular mortality increases by
approximately 28% and non-fatal coronary
event increases by approximately 20% in
mild to moderate COPD
Anthonisen et al, Am J Respir Crit Care Med 2002
Risk Factors for chronic
complex disease
Nutrition
Infections
Socio-economic
status
Aging Populations
Risk Factors for chronic
complex disease
Noxious particles
and gases
Host factors
Anti-oxidants
Lung inflammation
Oxidative stress
Anti-proteinases
Proteinases
Repair mechanisms
COPD pathology
Mucus hypersecretion
(chronic bronchitis)
Alveolar wall destruction
(emphysema)
From the lung to the systemic inflammation
Association between chronic obstructive pulmonary
disease and systemic inflammation: a systematic review
and a meta-analysis
Dentener
Eid
Mannino
Mendall
Yasuda
Pooled summary
-0.2
0.0
0.2
0.4
0.6
0.8
1.0
1.2
1.4
1.6
1.8
2.0
Standardised
mean difference
of
CRP
Standardised
mean difference
of
CRP
Greater
in controls
Greater in COPD
Gan WQ et al. Thorax 2004; 59: 574-80
Cigarette smoking represents an independent
risk factor for cardiovascular disease
 Systemic oxidative stress
 Inflammatory mechanisms
 Haemostatic disturbances
 Lipid abnormalities
 Vascular endothelial dysfunction
Yanbaeva DG et al. Chest 2007;131:1557-66
Wannamethee SG et al. Eur Heart J 2005;26:1765-73
Primary outcome
To establish the point prevalence of
Airflow Limitation (AL) compatible with
COPD in current/former smokers with
established cardiac diseases, in Europe.
Secondary Outcomes
• To establish the overall burden of AL in patients with cardiac diseases,
stratified by cardiac disease type;
• To compare health status and healthcare resource utilisation in patients with
cardiac diseases with and without AL, and with or without prior COPD diagnosis;
• To explore the relationship between cardiac disease and risk factors with AL:
• To explore whether the type of cardiac disease diagnosis (IHD only, co-morbid
CHF, or co-morbid with other CV disease (other than CHF)) is related to the
presence and severity of AL, after adjustment for other risk factors of AL (e.g.
smoking),
• To explore whether the presence of AL is related to the severity of cardiac
disease;
• To explore overlapping genetic markers of COPD and cardiac diseases, in those
patients where genetic samples are collected.
Study population
• 3.000 former or current smoker, over the
age of 40, attending outpatient cardiac
clinics for a routine visit for the CV disease.
• 220 patients / unit
• Tempi
- start : 15 October 2011
- end: 10 April 2012012
~ 22 weeks
~ 10 pts/week
Inclusion criteria
• Subjects aged ≥40 years;
• Current or former smokers with ≥10 pack years;
• Subjects attending outpatient cardiac clinic (or equivalent)
fulfilling any of the following criteria:
Documented history of an Ischemic event,
Current diagnosis of stable IHD (including history of acute
Myocardial Infarction (MI) and angina pectoris) as diagnosed in
accordance with ESC guidelines (see Appendix 2),
Receiving regular therapy for IHD for >1yr,
• Subjects meeting these criteria will be eligible for the study, even
if they have other cardiac diseases or other co-morbidities;
• Subjects willing and able to sign study consent form.
Exclusion criteria
• Subjects for whom spirometry is contraindicated
• Subjects with recent surgery or MI (within 1 month);
lower respiratory tract infection or pneumothorax
(within 2 months); or stroke (within 12 months);
• Subjects with a pre-existing condition which, in the
opinion of the investigator, would compromise the
safety of the subject in this study.
Study Procedures
Procedures
Study visit
Written Informed Consent
Inclusion/Exclusion Criteria
Subject Demography
Spirometry
COPD Assessment Test, SF12, Cardiac
Health Profile questionnaires
Healthcare resource utilisation
Medical History
Blood Pressure, Heart Rate
BMI, Hip and waist circumference
Current Medication
Smoking status & pack years
GOLD screener
ATS Respiratory symptoms (abridged)
mMRC dyspnoea scale
Blood chemistry 2
O2 saturation
12-lead ECG
Chest X-ray
CT scan
Ejection fraction
X
X
X
X
X
Blood samples for storage 3
X
X
X
X
X
X
X
X
X
X
X
Retrospective data
capture 1
X
1. Where available, results from
X
X
X
X
X
the most recent test will be
collected
2. Including total cholesterol,
HDL-C, LDL-C, glucose
(HbA1c), hs-CRP, Pro-BNP
and fibrinogen, to be assessed
locally
3. Optional: Blood samples will
be collected for future
exploratory genetic analyses
Progetto ALICE
The study aims to determine, and raise awareness of, the
burden of AL disease in these patients and on healthcare
resource utilisation.
We hypothesise that patients with cardiac disease with and
without AL will differ in a number of characteristics, with
patients with comorbid AL reporting higher disease burden and
healthcare resource utilisation, especially in those patients
with undiagnosed and untreated AL.
Meeting del Dipartimento ad Attività Integrata di Oncologia,
Ematologia e Patologie dell’Apparato Respiratorio
Villa Pineta, 16 Luglio 2011
Grazie dell’attenzione
Buone vacanze!