Transcript Level 1 - ภาควิชาอายุรศาสตร์

The Update GINA guideline
2006 in Adult
ผศ. นพ. วัชรา บุญสวัสดิ์ M.D., Ph.D.
ภาควิชาอายุรศาสตร์ คณะแพทย์ ศาสตร์
มหาวิทยาลัยขอนแก่ น
Contents
• Changing concept in asthma treatment
• Old GINA guidelines
• New GINA2006
Changing concept in asthma treatment
short-acting
b2-agonists
Inh corticosteroid
Bronchospasm
Inflammation
Airway
Hyperresponsiveness
1975
1980
Combination
1985
Remodelling
1990
1995
2000
1995
1995
2002
Six-part Asthma Management Program
Goals of Long-term Management
• Achieve and maintain control of symptoms
• Prevent asthma episodes or attacks
• Maintain pulmonary function as close to normal levels as
possible
• Maintain normal activity levels, including exercise
• Avoid adverse effects from asthma medications
• Prevent development of irreversible airflow limitation
• Prevent asthma mortality
Six-part Asthma Management Program
Control of Asthma
• Minimal (ideally no) chronic symptoms
• Minimal (infrequent) exacerbations
• No emergency visits
• Minimal (ideally no) need for “as needed” use of β2agonist
• No limitations on activities, including exercise
• PEF circadian variation of less than 20 percent
• (Near) normal PEF
• Minimal (or no) adverse effects from medicine
Six-Part Asthma Management Program
1. Educate Patients
2. Assess and Monitor Severity
3. Avoid Exposure to Risk Factors
4. Establish Medication Plans for
Chronic Management
1995
5. Establish Plans for Managing
Exacerbations
6. Provide Regular Follow-up Care
Pharmacological therapy
 Relievers

Inhaled fast-acting
b2-agonists
 Controllers

Inhaled corticosteroids
Inhaled long-acting
b2-agonists
 Oral anti-leukotrienes
 Oral theophyllines

Classification of asthma severity: GINA 1995
4
3
1
Intermittent
2
Mild
persistent
Moderate
persistent
Severe
Persistent
Night symptoms
<1/wk
<2/mo
>1/wk
>2/mo
daily
>1/wk
daily
frequent
PEFR
>80%
>80%
60-80%
<60%
20-30%
>30%
Day symptoms
PF variability
<20%
>30%
GINA1995
Level 4
Level 3
Level 2
Level 1
High dose ICS
+other controller
high dose ICS
ICS
B2 agonist prn
GINA1995
GINA
2002
Level 4
Level 3
Level 2
Level 1
High
ICS+LABA
dose ICS
+other controller
high
dose ICS
ICS+LABA
ICS
B2 agonist prn
Guidelines Implementation
?
? ? ? ?
?
?
What is the problem?
Classification of asthma severity: GINA 1995
Intermittent
Day symptoms
Night symptoms
PEFR
PF variability
<1/wk
<2/mo
Mild
persistent
>1/wk
>2/mo
Moderate
persistent
daily
>1/wk
Severe
Persistent
daily
frequent
TOO
>80% COMPLICATE
>80%
60-80%
<60%
<20%
20-30%
>30%
>30%
Gaining Optimal Asthma controL (GOAL) study
Bateman E. Am. J. Respir. Crit. Care Med.2004:836-844
Common views of control?
Symptoms
Some?
Salbutamol use
A puff a day?
PEF am
>80% on most days?
Night-time awakenings
Occasional?
Exacerbations
Rarely?
Emergency visits
Rarely?
Treatment related adverse events
enforcing change in therapy
None?
TOTAL CONTROL definition
Symptoms
No
Some?
Symptoms
Salbutamol
No use
Salbutamol
A puff a day?
use
Every
day
PEF am
>80%
PEF am
>80%
on most
days?
Night-timeNo
awakenings
Occasional?
Night-time
awakenings
No
Exacerbations
Exacerbations
Rarely?
Emergency
No visits
Rarely?visits
Emergency
Treatment related adverse events
No in therapy
enforcing change
Treatment related adverse events
enforcing None?
change in therapy
TOTAL CONTROL is ALL of these sustained for at least 7 of 8 weeks
GOAL Study
GOAL: a unique and innovative study
Phase I
Phase II
Oral
prednisolone +
SFC 50/500
8-week control assessment
4-week control assessment
SFC 50/500 or FP 500
Stratum 3
SFC 50/250
or FP 250
Step 2
SFC 50/500
or FP 500
Step 1
SFC 50/250
or FP 250
Strata 1 & 2
SFC 50/100
or FP 100
Step 3
Step 2
Step 1
Visit
Week
1
-4
2
0
3
4
4
12
5
24
6
36
SFC, salmeterol/fluticasone propionate combination; FP, fluticasone propionate
7
8 9
52 56
GSK data on file, 2003
% patients achieving total controlled
asthma
Patients can achieve total control
regardless of asthma severity
Seretide Phase 2
Seretide Phase 1
100
FP Phase 2
FP Phase 1
80
60
50%
44%
40%
40
29%
28%
16%
20
0
Steroid naïve
Low dose
ICS
Moderate dose
ICS
Approximately 50% patients achieved Total Control
More patients achieved well controlled
asthma with Seretide versus FP
% patients achieving well-controlled
asthma
Seretide Phase 2
Seretide Phase 1
100
FP Phase 2
80
75%
78%
FP Phase 1
70%
60%
62%
60
47%
40
20
0
Steroid naïve
Low dose
ICS
Moderate dose
ICS
The recommendations for asthma
management are laid out in five interrelated
components of therapy:
1.
2.
3.
4.
5.
Develop Patient/Doctor Partnership
Identify and Reduce Exposure to Risk Factors
Assess, Treat, and Monitor Asthma
Manage Asthma Exacerbations
Special Considerations
Levels of Asthma Control
Characteristic
Controlled
(All of the following)
Partly Controlled
(Any measure present in
any week)
Uncontrolled
Daytime symptoms
None (twice or
less/week)
More than twice/week
Limitations of activities
None
Any
Nocturnal
symptoms/awakening
None
Any
Three or more
features
of partly
controlled
asthma present
Need for reliever/
rescue treatment
None (twice or
less/week)
More than twice/week
Lung function (PEF or
FEV1)‡
Normal
< 80% predicted or
personal best (if known)
Exacerbations
None
One or more/year*
One in any week†
* Any exacerbation should prompt review of maintenance treatment to ensure that it is adequate.
† By definition, an exacerbation in any week makes that an uncontrolled asthma week.
‡ Lung function is not a reliable test for children 5 years and younger.
Pharmacological therapy
 Relievers

Inhaled fast-acting
b2-agonists
 Controllers

Inhaled corticosteroids
Inhaled long-acting
b2-agonists
 Oral anti-leukotrienes
 Oral theophyllines

GINA1995
GINA
2002
Level 4
Level 3
Level 2
Level 1
High
ICS+LABA
dose ICS
+other controller
high
dose ICS
ICS+LABA
ICS
B2 agonist prn
Simplified asthma treatment
Asthma Patient
Total control
Assess Control
Treatment
No day symptoms
No night symptoms
No rescue medication
No ER visit
PEFR >80%
ICS 500ug/d
+
ICS 500ug/d Other controller
1995
2002
2006
Implementation
Thank you