The Update GINA guideline The Update GINA guideline 2006 in Adult2006 in Adult

ผศ. นพ. วัชรา บุญสวัสดิ์ M.D., Ph.D.

ภาควิชาอายุรศาสตร คณะแพทยศาสตร

มหาวิทยาลัยขอนแกน

Contents

• Changing concept in asthma treatment

• Old GINA guidelines

• New GINA2006

1975 1980 1985 1990 1995 2000

Changing concept in asthma treatment

Airway Hyperresponsiveness

Bronchospasm Inflammation

Remodelling

short-acting b2 -agonists Inh corticosteroid Combination

1995

1995

1994

1997

2002

2004

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 β2- agonist

• 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

5. Establish Plans for Managing Exacerbations

6. Provide Regular Follow-up Care

1995

Pharmacological therapy

ControllersInhaled corticosteroids

Inhaled long-acting β2-agonistsOral anti-leukotrienes Oral theophyllines

RelieversInhaled fast-acting β2-agonists

Classification of asthma severity:

GINA 1995

Day symptoms

Night symptoms

PEFR

PF variability

Intermittent

<1/wk

<2/mo

>80%

<20%

>1/wk

>2/mo

>80%

20-30%

daily

>1/wk

60-80%

>30%

daily

frequent

<60%

>30%

Mild

persistent

Moderate

persistent

Severe

Persistent1

23

4

High dose ICS+other controller

B2

agonist prnLevel 1

ICS

high dose ICS

Level 2

Level 3

Level 4

GINAGINA19951995

High dose ICS+other controller

B2

agonist prnLevel 1

ICS

high dose ICS

ICS+LABA+other controller

Level 2

Level 3

Level 4

ICS+LABA

GINAGINA19951995GINAGINA 20022002

Guidelines ImplementationGuidelines Implementation

What is the problem?

?? ??

???

Classification of asthma severity:

GINA 1995

Day symptoms

Night symptoms

PEFR

PF variability

Intermittent

<1/wk

<2/mo

>80%

<20%

>1/wk

>2/mo

>80%

20-30%

daily

>1/wk

60-80%

>30%

daily

frequent

<60%

>30%

Mild

persistent

Moderate

persistent

Severe

Persistent

TOO COMPLICATE

GGaining aining OOptimal ptimal AAsthma sthma controcontroLL (GOAL) study(GOAL) study

Bateman E. Am.

J.

Respir.

Crit.

Care Med.2004:836-844

Common views of control?Common views of control?Some?

A puff a day?

>80% on most days?

Occasional?

Rarely?

Rarely?

Symptoms

Salbutamol use

PEF am

Night-time awakenings

Exacerbations

Emergency visitsTreatment related adverse events

enforcing change in therapy None?

Some?

A puff a day?

>80% on most days?

Occasional?

Rarely?

Rarely?

Symptoms

Salbutamol use

PEF am

Night-time awakenings

Exacerbations

Emergency visitsTreatment related adverse events

enforcing change in therapy None?

GOAL Study

TTOTALOTAL CCONTROLONTROL definitiondefinition

Symptoms

Salbutamol use

>80% PEF am

Night-time awakenings

Exacerbations

Emergency visits

Treatment related adverse events enforcing change in therapy

No

No

Every day

No

No

No

No

TOTAL

CONTROL

is ALL of these sustained for at least 7 of 8 weeks

Strata 1 & 2

GOAL: a unique and innovative studyGOAL: a unique and innovative studyOral

prednisolone +SFC 50/500

Stratum 3

Step 3

SFC 50/500 or FP 500

VisitWeek

SFC, salmeterol/fluticasone propionate combination; FP, fluticasone propionate GSK data on file, 2003

1 2 3 4 5 6 7 8 9- 4 0 4 12 24 36 52 56

Phase IPhase II

8-week control assessment4-week control assessment

SFC 50/500 or FP 500

Step 2SFC 50/250 or FP 250

Step 1

Step 2

SFC 50/250 or FP 250

Step 1

SFC 50/100or FP 100

Seretide Phase 2Seretide Phase 1

FP Phase 2FP Phase 1

Steroid naïve Low doseICS

Moderate doseICS

Patients can achieve total control Patients can achieve total control regardless of asthma severityregardless of asthma severity

40%50%

28%

44%

16%

29%

0

20

40

60

80

100

% p

atie

nts

achi

evin

g to

tal c

ontro

lled

asth

ma

Approximately 50% patients achieved Total Control

More patients achieved well controlled More patients achieved well controlled asthma with Seretide versus FPasthma with Seretide versus FP

Steroid naïve Low doseICS

Moderate doseICS

70%60%

75%

47%

62%

78%

0

20

40

60

80

100

% p

atie

nts

achi

evin

g w

ell-c

ontro

lled

asth

ma

Seretide Phase 2Seretide Phase 1

FP Phase 2FP Phase 1

The recommendations for asthma management are laid out in five interrelated components of therapy:

1. Develop Patient/Doctor Partnership2. Identify and Reduce Exposure to Risk Factors3. Assess, Treat, and Monitor Asthma4. Manage Asthma Exacerbations5. Special Considerations

Levels of Asthma ControlCharacteristic 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 Three or more featuresof partly controlledasthma present

Limitations of activities None Any

Nocturnal symptoms/awakening

None Any

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

ControllersInhaled corticosteroids

Inhaled long-acting β2-agonistsOral anti-leukotrienes Oral theophyllines

RelieversInhaled fast-acting β2-agonists

High dose ICS+other controller

B2

agonist prnLevel 1

ICS

high dose ICS

ICS+LABA+other controller

Level 2

Level 3

Level 4

ICS+LABA

GINAGINA19951995GINAGINA 20022002

Simplified asthma treatment

Assess Control

ICS 500ug/d

Asthma Patient

Treatment

ICS 500ug/d+Other controller

No day symptomsNo night symptomsNo rescue medicationNo ER visitPEFR >80%

Total control

1995

1994

1997

2002 2006

2004

ImplementationImplementation

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