smart therapy
TRANSCRIPT
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
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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