Smart therapy

Presented By :

Dr. Md. Khairul Hassan Jessy Associate Professor

Respiratory MedicineNIDCH, Dhaka

Objective

• To focus on –

management of persistent

asthma

using a single inhaler both for

maintenance & additional rescue

use

•Asthma is a global concern

Facts About Asthma

• Asthma occurs in all countries

regardless of the level of

development

Facts About Asthma

• It is one of the major

non-communicable diseases

affecting the airways

Facts about Asthma

• It occurs in people of all ages

Facts About Asthma

•Asthma is often under-

diagnosed and under-treated,

creating a substantial burden

to individuals and families

and possibly restricting

individuals’ activities for a

lifetime.

Asthma: limits daily-life activities

0

20

40

% o

f pa

tien

ts

60

Social activities

Career Choice

Housekeeping

Lifestyle

Normal Physical Activity

SleepingSports

Asia Pacific Europe US

Facts About Asthma

• Despite effective pharmacological

options for treating asthma most

patients fail to achieve

good control

Patients Currently Achieving Control

Not Well-ControlledWell-Controlled

Only 5% of patients

achieve asthma control

Rabe et al. Eur Respir J, 2000

Facts About Asthma

Non adherence is common

with

Overreliance on short acting β2

agonist and

Underuse of inhaled corticosteroids

Short acting β – 2 agonist

Inhaled corticosteroid

Deaths due to asthma are

uncommon but are of

serious concern because

many of them are

preventable

Facts About Asthma

•Most asthma related deaths occur

in low and lower middle income

countries

Asthma related mortality is

higher among the poor

Asthma related mortality is higher

among the poor

Facts About Asthma

• Through appropriate treatment such as using

inhaled corticosteroids to ease bronchial inflammation, the number of asthma-related

deaths can be reduced

Fluticasone Propionate( ICS )

Use of ICS can reduce asthma related mortality

Global Burden of Asthma

• Some 334 million people currently

suffer from asthma

Global Burden of Asthma

• It affects 1-18 % of the population in different countries

& the prevalence is rising

Global Burden of Asthma

• 14% of the world’s children

experience asthma symptoms

Situation in Bangladesh

• About 7 million people

(5.2% of the population) are suffering from asthma

• 4 million of them are in 1-15 years age group

(NAPS, 1999]

Situation in Bangladesh

• It is very likely that the

number of asthma patients

has increased many times

in last few years

Situation in Bangladesh

• >90% do not get modern treatment

Source: First National Asthma Prevalence Study (NAPS, 1999]

• Bronchial asthma

is a chronic inflammatory disease of

the airways that is characterized by

respiratory symptoms associated

with

variable airflow obstruction, airway

hyper-responsiveness, and

airway remodeling

History

• Asthma was first recognized in

ancient Egypt & treatment was inhalation of frankincense

Source : Wikipedia

History

Asthma was first recognized & named by Hippocrates

100 years of asthma treatment

AdrenalineOral steroidsTheophylline

Inhaled β2-agonistsSodium cromoglycate

Inhaled anticholinergicInhaled steroids

Long-actingβ2-agonists

Leukotrieneinhibitors

Anti-IgE

1900 1960 1970 1980 1990 2000...

History

In the last few years there In the last few years there

have been remarkable have been remarkable

progress and outstanding progress and outstanding

improvement in the improvement in the

management of Bronchial management of Bronchial

AsthmaAsthma

History

•Newer combinations in many

dosage forms are evolving

to achieve optimal control

History

• Combination therapy is now

considered to be an

excellent choice for

persistent asthma

Causes

•The fundamental causes are

not completely understood

Causes

• The strongest risk factors are a

combination of

genetic predisposition

with environmental exposure to

allergens/asthma triggers

Pathophysiology

• There are 3 fundamental

changes associated with

inflammation in asthma

Pathophysiology

• These are

▫ Airway hyperresponsiveness

▫ Variable airflow obstruction

( usually reversible )

▫ Airway remodeling

Pathophysiology

It is the most important fundamental change in asthma

Asthma Symptoms

• Coughing

•Wheezing

• Chest

tightness

• Shortness of

breath

Symptoms

• Symptoms may occur several times in a day or week in

affected individuals.

• For some people the symptoms become worse

during physical activity or at night.

Examination

• BP examination & examination of

both lungs fields are 2 important

steps to exclude Bronchial from

Cardiac asthma

EPA Indoor Environments Division, Jan 2001, Slide 60

of asthmaTwo parts

Lung function assessment

The important lung function

tests are :

• forced expiratory volume in 1

second (FEV1) and peak

expiratory flow (PEF)

Lung Function Assessment

Classification

• Asthma is classified into four

groups

~ Intermittent asthma

~ Persistent asthma

~ Acute exacerbation

~ Special variants

Treatment

It is not a curable diseaseIt is not a curable disease

But to a large extent But to a large extent

controllable controllable

With With

education, caution & education, caution &

medication medication most cases of asthma can be most cases of asthma can be

effectively managedeffectively managed

Treatment

• Long term goals of asthma

management –▫ to achieve good control of symptoms

& maintain normal activity levels

▫ to minimize future risk of

exacerbation

Treatment

•Asthma management is flexible

Treatment

The drugs used in asthma

should be given in a stepwise

fashion

Asthma Medications

Medicine used to treat

asthma are basically three

types-

• Relievers

• Preventers

• Protectors

Asthma Medications

Drugs are available in the form

of

› Inhaler

›Oral route

›Parentaral route

›Suppository

›Nebulizer solution

Asthma Medications

Asthma Medications

Treatment

• The guidelines for the

management of

persistent asthma in adults

recommend

an inhaled corticosteroid

(ICS)

Treatment

• ICS are the most effective

treatment for inflammatory

component of asthma

(disease preventers)

• ICS targets the inflammation in asthma

Treatment

• Most studies show that

early treatment with ICS

prevents

decline in lung function

Treatment

• When asthma is

inadequately controlled

with a moderate dose of ICS –

combination therapy

is recommended

Treatment

• Several studies have shown that

combination of LABA to ICS is

more effective than increasing

the dose of ICS alone

Source : GINA

Treatment

• The combinations now

available for clinical use-

budesonide & formeterol

fluticasone & salmeterol

beclomethasone & formeterol

Widely Used

Treatment

•Most recent ICS / LABA

combination is Mometasone

furoate combined with

Formoterol

Treatment

• Combination medications are

available in MDI & DPI forms

• Comparison of different

medication delivery device

has shown similar results

Long Acting β2 Agonist ( LABA )

• Two drugs are in common clinical use

- Salmeterol

- Formoterol

• Action lasts for up to 12 hours

Mechanism of Action

• β-2 agonists relax the contracted airway smooth

muscle through a direct action on β-2

adreno - receptors

LABA

• Formoterol has a rapid onset of action ( 1- 2 min ) and can be used as a reliever

• Salmeterol has a delayed onset of action and cannot be used as a reliever

Salmeterol

LABA : Speed of Action

• Fast Onset, Long Duration

Inhaled Formoterol

• Slow Onset, Long Duration

Inhaled Salmeterol

Oral Bambuterol

Onset of Action: β2-Agonists

90

0 5 10 15 20 25

Placebo

Salmeterol Diskhaler50 µg

Albuterol Turbuhaler50 µg

FormoterolTurbuhaler 9 µg

▲ FEV (%)

Comparisons 3 min after inhalation of bronchodilator *

LABA

• An important observation of

many large scale trials is that

Inhaled Formoterol has a rapid

onset of action similar to that

of Salbutamol

LABA

• Long acting β 2 agonists -

Salmeterol & formoterol

should not be used as

monotherapy

Caution

• LABA monotherapy may increase the risk of asthma related death

SMART

• The acronym SMART stands

for

Single /Symbicort Maintenance

And

Reliever Therapy

SMART

• 2 active ingredients are delivered via a single inhaler

• Budesonide – an anti-inflammatory corticosteroid

• Formoterol - a rapid acting & long

lasting β-2 agonist,bronchodilator

Budesonide & Formeterol

Regular Maintenance with Bud

Long Acting Bronchodilatation with Form

Rapid anti-inflammatory effect with Bud

Rapid Bronchodilatation with Form

SMART

• In 2001 , Astrazeneca

launched a new product

Symbicort turbuhaler containing

2 active ingredients

( budesonide & formoterol ) via a

single inhaler

SMART

• A novel treatment approach

known as Single Maintenance And

Reliever Therapy ( SMART ) was

focused

SMART

• Due to its unique properties Formoterol -budesonide is

currently the only ICS/ LABA combination that is approved to

be used as maintenance & relief in one inhaler

®

Symbicort and Asthma – Mechanism of Action.mht

Onset of action of Budesonide + Formoterol is similar to Salbutamol

Budesonide + Formoterol has better efficacy than Salmeterol + Fluticasone

Budesonide + Formoterol compared with fixed dose

Salmeterol + Fluticasone

Budesonide + Formoterol

Treatment

• The traditional approach is to

prescribe an ICS/LABA to achieve

control and additional SABA for

rescue use so most patients will

use at least 2 inhalers

Treatment

• In SMART model the patient is

provided with 1 ICS/LABA inhaler

both for maintenance and

additional rescue use in place of

SABA

•With SMART there is no need for a separate SABA

SMART

•Here the drugs are used to

provide a stable dosing regime (FD)

to achieve day to day control

but

• The dose can be increased during

worsening of symptoms ( AMD )

SMART

• The maintenance dose is

adjustable but a minimum of 2

doses/day should be

administered as one dose

twice daily

SMART

• Dose is to be individualized

and adjusted according to

severity

•When control has been

achieved the dose should

be titrated to the lowest

effective dose

08/12/17

113

Dose is increased with asthma worsening. When control is maintained the dose is titrated to the lowest effective

Key to Success

•Good communication between

doctor and patient is an integral

part of management using

SMART

Limitations

• Patients should be warned about

maximum recommended dose ( up

to 8 puffs per day )

Limitations

• The issue of safety in

children on long term use

of SMART is yet to be

resolved

Limitations

• This strategy is not suitable for

those who find it difficult to

recognize worsening of symptoms

Benefits

•Managing asthma in SMART

fashion is a safe and simplified

approach

• Provides rapid relief of symptoms

Benefits

• Reduces the future risk of

exacerbations

• A lower dose of ICS is needed

compared to ICS therapy alone

Benefits

• SMART reduces exacerbations

in terms of rate, severity & time to first exacerbation

Benefits

•Reduces the risk of emergency room / hospital visits

Benefits

• Reduces the number of visits to a doctor

Benefits

• Patient can increase the dose during worsening of symptoms

Benefits

• SMART strategy is cost effective

Benefits

• Offering good control of asthma improves quality of

life….

SMART

• This treatment approach

has been approved by the

GINA guideline as an

effective treatment strategy

SMART

• This treatment strategy is

given an evidence A rating

by GINA

Evidence A

means evidence from well

designed RCTs taking

substantial number of

studies involving substantial

number of participants

GINA

• GINA is one of the founding participants of WHO’s Global Alliance against Respiratory Diseases (GARD)

SMART/caution

• SMART is NOT indicated for

the relief of acute

bronchospasm

SMART/caution

• SMART should not be

initiated during rapidly

deteriorating or potentially

life-threatening episodes of

asthma

Safety in Pregnancy

• There have been limited studies on terratogenic risk

Safety in Pregnancy

• LABA

Formoterol – pregnancy

category C

• ICS

Budesonide - pregnancy

category B

Contraindications

•Hypersensitivity to

budesonide,

formoterol or

inhaled lactose

Hypersensitivity

Take home messages

• Asthma is a chronic

inflammatory disorder

affecting the airways

Take home messages

• Long term asthma control

using ICS ( alone/ in

combination with LABA ) are

the corner stone of therapy

in persistent asthma

Take home messages

• Combination of

Budesonide & Formoterol

using

AMD via a single inhaler ( SMART ) now appears to be

an excellent approach

Take Home Messages

• It offers a simple , effective &

safe approach to persistent

asthma management for

physician & patient

Conclusion

• Although asthma cannot be cured,

appropriate management can

control the disease and enable

people to enjoy a good quality of

life

Conclusion

•SMART is one such option

Conclusion

• It represents a new & unique

way of treating patients with

moderate to severe asthma

Conclusion

•We are now trying to provide

the best possible effort to

reduce the burden of asthma

related morbidity and

mortality in BD

NIDCH, Bangladesh

Providing services to asthmatic patients

A name of

NIDCH

Conclusion

• But

UNIVERSAL HEALTH COVERAGE

(UHC)

continues to be an important

issue

Conclusion

•UHC means that all

individuals & communities

receive the health services

they need without suffering

financial hardship

Conclusion

•Political commitment ,

momentum & action plan are essential to reach the goal

Conclusion

• Like Global Asthma Network,

we are also waiting for a

world where no one suffers

from asthma

To myself I am only a child playing on the beach, while vast oceans of truth lie

undiscovered before me

- Isaac Newton