New Asthma Guidelines: How to Put in Your Daily Practice

New Asthma Guidelines:
How to Put in Your Daily Practice
Michael J. Welch MD, FAAP, FAAAAI
Co-director, Allergy and Asthma Medical Group and
Research Center
Clinical Professor, University of California, San Diego
School of Medicine
Kaiser Symposium
November 12, 2010
Disclosures
I have the following financial relationships with
manufacturer(s) of commercial product(s) and/or
provider of commercial services discussed in this CME
activity:
• Research support from: Alcon, Alexza, Amgen, Antigen Labs,
Apotex, Astellas, AstraZeneca, Boehringer Ingelheim, Capnia,
Critical Therapeutics, GlaxoSmithKline, MAP, MEDA, Merck,
Novartis, Schering-Plough, Teva, UCB
• Consultant/Speaker for: AstraZeneca, GlaxoSmithKline, Merck,
PARI, Sanofi-Aventis, Sepracor, Teva
1
Other Disclosure
Case for Audience Response
Jimmy, 7 y.o. on ICS rx for persistent asthma,
still needing albuterol 3d/week, and in ER last month
You are seeing him today.
What is the most important thing to do?
1.
2.
3.
4.
Change to a different ICS product
Check his medication adherence/inhaler technique
Question the dx of asthma, and do further tests
Add a 2nd controller med or increase ICS dose
2
2007 NAEPP Guidelines
So, what’s new?
National Institutes of Health, National Heart, Lung and Blood Institute.
Expert Panel Report 3: Guidelines for the Diagnosis and Management
of Asthma (EPR-3 2007). NIH Item No. 08-4051.
Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm.
2007 NAEPP Guidelines
So, what’s new?
A: Not much!
Just re-packaged
nes
ideli
u
G
Old
National Institutes of Health, National Heart, Lung and Blood Institute. Expert Panel Report 3:
Guidelines for the Diagnosis and Management of Asthma (EPR-3 2007). NIH Item No. 08-4051.
Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm.
3
2007 Guidelines
What’s not new?
• Severity dictates therapy
– Intermittent versus persistent distinction
– Rule of 2’s
– 4 levels of severity (intermittent and 3 persistent)
• ICS therapy preferred rx for persistent
– Even for mild disease (LTA non-preferred alternative)
• Asthma Action Plans
• Spirometry recommended
NIH/NHLBI 2007
What are included in the rule of
2’s?
1.
2.
3.
4.
5.
6.
Symptoms 2 days a month
Symptoms 2 nites a month
Symptoms 2 days a week
2 canisters per year
1 canister every 2 months
2 hard to remember the dumb rule
4
What are included in the rule of
2’s?
1. 2 days a month
2. 2 nites a month
3. 2 days a week
4. 2 canisters per year
5. 1 canisters every 2 months
6. 2 hard to remember the dumb rule
Asthma severity
Intermittent
<2x/wk day
<2x/mo night
prn albuterol
“Rule of Two’s”
Mild: <daily
Persistent Moderate: daily
Severe: continual
daily controller
NIH/NHLBI 2007
5
2007 Guidelines
So, what’s new?
•
•
•
•
•
“Mild intermittent” “Intermittent”
New 2 in rule of 2’s = > 2 exacerbations per yr
Asthma predictive index
Concept of “impairment” and “risk”
Concept of “control”
– More important than severity classification
– Use a validated tool
• Airway remodeling and ICS’s
• 6 steps of therapy (versus old 4)
– Appearance of omalizumab (Xolair)
– LABA safety issue
• Update on available asthma medications
Classification of Asthma Severity
Components of Severity
NIH/NHLBI 2007
Persistent
Intermittent
Mild
Impairment
Severe
Daily
Throughout
the day
Symptoms
< 2 days/week
Nighttime
awakenings
< 2 x/month
1-2x/month
3-4x/month
>1x/week
<2 days/week
>2 days/wk but not
daily
Daily
Several times
per day
None
Minor
limitation
Some
limitation
Extremely
limited
FEV1 = 60% but
<80% pred
FEV1/FVC
reduced 5%*
FEV1 <60%
pred
FEV1/FVC
reduced 5%*
Short-acting beta2agonists use
(symptom control;
not prevention of
EIB)
Interference with
normal activity
Lung Function
Risk
Moderate
>2 days/week but
not daily
Exacerbations
(consider frequency
and severity)
Normal FEV1
(between exacerbations)
FEV1 >80% pred
FEV1/FVC nl*
FEV1 >80% pred
FEV1/FVC nl*
0-2/year
> 2/year
Frequency and severity may fluctuate over time
For patients in any severity category
Relative annual risk of exacerbations may be related to FEV1
8-19 yr: 85% 20-39 yr: 80% 40-59 yr: 75% 60-80 yr: 70%
6
Classification of Asthma Control
Well
Controlled
Not Well
Controlled
Very Poorly
Controlled
Symptoms
<2 days/week
>2 days/week
Throughout the
day
Nighttime awakenings
<2/month
1-3/week
>4/week
<2 days/week
>2 days/week
Several times per
day
None
Some limitation
Extremely limited
Components of Severity
Short-acting beta2-agonists use for
symptom control (not prevention of
EIB)
Impairment
Interference with normal activity
!
B
M
U
>80% predicted/
personal best
FEV1 or peak flow
Validated Questionnaires
ATAQ
ACQ
ACT
Exacerbations
D
60-80% predicted/
personal best
<60% predicted/
personal best
0
<0.75
>20
1-2
>1.5
16-19
3-4
N/A
<15
0-1/year
2 -3/year
>3/year
Progressive loss of lung function
Evaluation requires long-term follow-up care
Treatment-related adverse effects
Medication side effects can vary in intensity from none to very
troublesome and worrisome. The level of intensity does not
correlate to specific levels of control but should be considered in
the overall assessment of risk
NHLBI 2007
Risk
% of Pediatric Subjects
With Asthma
Approximately 46% of pediatric patients
uncontrolled
60
54%
46%
40
20
0
Well Controlled
Uncontrolled
Weighted prevalence.
Results from cross-sectional epidemiological survey of patients in pediatric primary care offices, regardless of reason for visit.
Data for 2429 pediatric patients with a self-reported physician diagnosis of asthma who completed the Childhood Asthma
Control Test (for children aged 4 to 11 years) or the Asthma Control Test™ (for children aged 12 to 17 years). Uncontrolled
asthma defined as a score of ≤19 on either test.
Asthma Control Test is a trademark of QualityMetric Incorporated.
Liu AH et al. J Peds. 2010.
7
35% of children with asthma
seen for nonrespiratory reason were uncontrolled
100
% of Children
80
54%
60
35%
40
20
0
Respiratory Reason
Nonrespiratory Reason
Weighted prevalence.
Results from cross-sectional epidemiological survey of patients in pediatric primary care offices, regardless of
reason for visit. Data for 2429 pediatric patients with a self-reported physician diagnosis of asthma who
completed the Childhood Asthma Control Test (for children aged 4 to 11 years) or the Asthma Control Test™ (for
children aged 12 to 17 years). Uncontrolled asthma defined as a score of ≤19 on either test.
Asthma Control Test is a trademark of QualityMetric Incorporated.
Liu AH et al. J Peds. 2010
Prevalence of uncontrolled asthma
by race/ethnic origin
% of Pediatric Subjects With
Uncontrolled Asthma
100
80
55%
60
43%
51%
41%
40
20
0
White
African American
Hispanic
Other
Weighted prevalence.
Results from cross-sectional epidemiological survey of patients in pediatric primary care offices, regardless of
reason for visit. Data for 2429 pediatric patients with a self-reported physician diagnosis of asthma who
completed the Childhood Asthma Control Test (for children aged 4 to 11 years) or the Asthma Control Test™ (for
children aged 12 to 17 years). Uncontrolled asthma defined as a score of ≤19 on either test.
Asthma Control Test is a trademark of QualityMetric Incorporated.
Liu AH et al. J Peds. 2010
8
Spirometry – how many do it?
• Routinely?
• Well?
BAD NEWS
Office spirometry in pediatrics
• 10 pediatricians trained in spirometry
(2 5 hr sessions)
• Spirometry done by pediatrician, PF lab
(pulmonologist) same day/similar spirometer
• 109 pts
• 22% tests unacceptable (acceptability/reproducibility)
• 21% interpreted incorrectly
• Conclusion: training/certification needed
Zanconato et al Pediatrics 2005; 116:e792-797
9
So, ………………..
Want to be off the hook?
Feel less guilty?
ACT now!!
Childhood Asthma Control Test
Questions Completed by Child Age 4-11 Years
1. How is your asthma today?
SCORE
0
1
2
3
Very bad
Bad
Good
Very Good
2. How much of a problem is your asthma when you run, exercise or play sports?
0
It’s a big problem, I can’t do what I want to do.
1
2
It’s a problem and I don’t like it. It’s a little problem but it’s okay.
3
It’s not a problem.
3. Do you cough because of your asthma?
0
1
2
3
Yes, all of the time.
Yes, most of the time.
Yes, some of the time.
No, none of the time.
4. Do you wake up during the night because of your asthma?
0
1
2
3
Yes, all of the time.
Yes, most of the time.
Yes, some of the time.
No, none of the time.
10
Childhood Asthma Control Test
Questions Completed by Parent/Caregiver
5. During the last 4 weeks, on average, how many days per month did your child have any daytime asthma symptoms?
5
4
3
2
1
0
Not at all
1-3 days/mo
4-10 days/mo
11-18 days/mo
19-24 days/mo
Everyday
6. During the last 4 weeks, on average, how many days per month did your child wheeze during the day because of asthma?
5
4
3
2
1
0
Not at all
1-3 days/mo
4-10 days/mo
11-18 days/mo
19-24 days/mo
Everyday
Score < 19 :
Score > 19:
7. During the last 4 weeks, on average, how many days per month did your child wake up during the night because of asthma?
5
4
3
2
1
0
Not at all
1-3 days/mo
4-10 days/mo
11-18 days/mo
19-24 days/mo
Everyday
TOTAL
Possible total scores range from 0 to 27
Score < 19: child’s asthma not likely under control
0
1
2
3
Benefits of Childhood ACT
• Simple/short; assesses control
• Encourages child-parent dialogue
• Easy to implement in office
• Easy to integrate in to busy office setting
Data on file, GlaxoSmithKline.
11
Airway remodeling and ICS’s
NIH/NHLBI 2007
• “.. evidence suggests that currently available therapy controls but
does not modify the underlying disease process.”
• “The Expert Panel does not recommend using ICS’s for the
purpose of modifying the underlying disease process (e.g.
preventing persistent asthma).”
Reason to use ICS’s: they work the best
NIH/NHLBI 2007
Old guidelines: 4 steps
(> 5 years)
Mono ICS
prn albuterol
Step 1
Step 2
Mild
Preferred:
Low-dose ICS
Intermittent
SABA prn
Alternative:
LTM, cromolyn, nedocromil,
or
Combination
Step 3
Moderate
Preferred:
Low- to mediumdose
ICS + LABA
“Kitchen sink”
Step 4
Severe
Preferred:
High-dose ICS +
LABA
and
if needed
systemic
corticosteroids
Alternative:
↑ ICS to med dose
or
low- to med-dose ICS +
either LTM or theophylline
SR theophylline
ICS = inhaled corticosteroid; LABA = long-acting β2-agonist; LTM = leukotriene modifier.
NIH/NHLBI Guideline Update. June 2002. NIH Publication No. 02-5075.
12
Steps 3 and 4 split
split
Step 4
split
Severe
Step 3
Preferred:
Low- to mediumdose
Mild
Preferred:
ICS + LABA
Low-dose ICS
Intermittent
SABA prn
High-dose ICS +
LABA
and
if needed
systemic
corticosteroids
Moderate
Step 2
Step 1
Preferred:
Alternative:
LTM, cromolyn, nedocromil,
or
Alternative:
↑ ICS to med dose
or
low- to med-dose ICS +
either LTM or theophylline
SR theophylline
ICS = inhaled corticosteroid; LABA = long-acting β2-agonist; LTM = leukotriene modifier.
NIH/NHLBI Guideline Update. June 2002. NIH Publication No. 02-5075.
NEW
Intermittent
asthma
6 steps of therapy (> age 5 yrs)
Persistent asthma: daily medication
Level 4
Level 3
Step 4
Level 2
Step 3
Preferred:
Step 2
Level 1
Step 1
Preferred:
SABA prn
Preferred:
Low-dose ICS
Alternative:
LTM,
cromolyn,
nedocromil, or
theophylline
Medium-dose
ICS
or
Low-dose ICS
+ LABA*
Alternative:
Low-dose ICS
+ either LTM,
or
theophylline,
or zileuton
Preferred:
Mediumdose ICS +
LABA
Alternative:
Mediumdose ICS +
either LTM,
or
theophylline
or zileuton
Step 6
Step 5
Preferred:
Preferred:
High-dose
ICS + LABA
High-dose ICS
+ LABA + oral
corticosteroid
AND
Consider
omalizumab
for pts who
have
allergies
AND
Consider
omalizumab
for pts who
have allergies
Step up if
needed
(first, check
adherence and
environmental
control and
comorbid
conditions)
Assess
control
Step down if
possible
(and asthma
is well
controlled at
least 3
months)
Patient Education and Environmental Control at Each Step
*Note: for age 5-11 yrs, step 3 - Low-Dose ICS and either LABA , LTM, or theophylline
NIH/NHLBI 2007
13
Symptoms/albuterol use
My approach: 4 steps
1 = occass
2 = > 2 days/week
Step 4
3 = daily
*
Preferred:
High-dose ICS +
LABA
and
LTM
if needed
systemic
corticosteroids
Moderate
Step 2
Step 1
Preferred:
Low- to mediumdose
Mild
Preferred:
ICS + LABA
Low-dose ICS
Intermittent
SABA prn
Severe
Step 3
4 = a few times a day
Alternative:
LTM
Alternative:
↑ ICS to med dose
or
low- to med-dose ICS +
LTM
ICS = inhaled corticosteroid; LABA = long-acting β2-agonist; LTM = leukotriene modifier.
* Rule of 2’s
What about Singulair?
Intermittent
Asthma
Persistent asthma: daily medication
Level 4
Level 3
Step 4
Level 2
Step 3
Preferred:
Step 2
Level 1
Step 1
Preferred:
SABA prn
Preferred:
Low-dose ICS
Alternative:
LTM,
cromolyn,
nedocromil, or
theophylline
Medium-dose
ICS
or
Low-dose ICS
+ LABA
Alternative:
Low-dose ICS
+ either LTM,
or
theophylline,
or zileuton
Step 6
Step 5
Preferred:
Mediumdose ICS +
LABA
Alternative:
Mediumdose ICS +
either LTM,
or
theophylline
or zileuton
Preferred:
Preferred:
High-dose
ICS + LABA
High-dose ICS
+ LABA + oral
corticosteroid
AND
Consider
omalizumab
for pts who
have
allergies
AND
Consider
omalizumab
for pts who
have allergies
Step up if
needed
(first, check
adherence and
environmental
control and
comorbid
conditions)
Assess
control
Step down if
possible
(and asthma
is well
controlled at
least 3
months)
Patient Education and Environmental Control at Each Step
NIH/NHLBI 2007
14
LTA’s vs ICS’s in management
of asthma
Cochrane Review 2004
• 27 trials met inclusion criteria (adults & children)
• Greater improvement with ICS’s seen in:
FEV1, symptoms, nocturnal awakenings, rescue
medication use, symptom-free days, quality of
life.
“Inhaled steroids …. more effective than antileukotriene agents”
Ng et al Cochrane Database Syst Rev 2004
Daily % of pts with exacerbation episode (EE)
x age=44 mos (2-5 yr); n = 549 pts
32% decrease in
rate of exacerbations
P
(2.34 vs 1.60; p<.001)
P
M
M
montelukast (Singulair)
-- - - -
placebo
Bisgaard et al. Am J Respir Crit Care Med 2005; 171: 315-322.
15
Johnston NW et al Pediatrics. 2007
“Back to school” montelukast study
Cumulated “days with worse asthma symptoms”
N = 194; ages 2 – 14 yrs; known asthmatics
Cumulated Worse Days/Subjects
4.00
3.50
3.00
Placebo
Montelukast or placebo added 9/1/05
to usual asthma rx (< 50% on ICS’s)
53% reduction (p<.02)
2.50
2.00
Montelukast
1.50
1.00
Unscheduled MD visits for asthma
0.50
0.00
18
0
1
2
3
4
5
Week
Recent study –
no benefit
6
P = .011
P
4
M
Weiss KB, et al. Ann Allergy Asthma Immunol 2010
Dr. Flo Vent
Dr. Singh U. Lair
ICS’s
•
•
•
•
Gold standard; most effective
Multiple modes of action
? prevent airway remodeling
Comparison studies favor
ICS’S
• Safety record good; growth
issue overstated
LTA’s
•
•
•
•
•
Effective (subjective/objective)
Airway remodeling “oversold”
Convenient (oral, qd dosing)
Special niche: mild asthma
Comparison studies in
moderate asthma - not mild
• Excellent safety record
• Improvement in AR symptoms
16
The way I see it ……
• Since airway remodeling:
–
–
–
–
–
Data limited, conflicting
Not in all pts
Hard to predict which pt
May not be clinically relevant
ICS’s may or may not prevent
• LTA (e.g. montelukast) reasonable alternative
– Mild disease
– Add on
– Intermittent?
• Monitoring essential!!
Which ICS?
17
QV
r
Advai
S
ic ort
b
m
y
ar
Great medications
Alvesco
Pulmico
rt
ent
Flov
rt
Azmaco
Poor inhaler technique
Steroid phobia
FDA-approved ages for ICS use in children in US
CIC (Alvesco)
BUD DPI (Pulmicort)
MOM (Asmanex)
BDP MDI (HFA) (QVar)
FP HFA MDI (Flovent)
FP DPI (Flovent Dischaler 50 ugm)
Nebulized BUD (Pulmicort)
0
1
2
3
4
5
6 7 8
9 10 11 12 13 14 15 16
Ages of Children (y)
FP = fluticasone propionate; BDP = beclomethasone dipropionate; BUD = budesonide;
TAA = triamcinolone acetonide; MOM = mometasone CIC = ciclesonide
18
Relative ICS potency
on a molecule basis
•
•
•
•
•
•
•
Mometasone (Asmanex)
Fluticasone (Flovent)
Ciclesonide (Alvesco)
BDP (QVar)
Budesonide (Pulmicort)
Triamcinolone (Azmacort)
Flunisolide (AeroBid)
2
2
2
1
1
1/2
1/2
But, potency may be over-rated:
% lung deposition, mcg/puff, # puffs/d can compensate for potency
A lv
esc
o
Flovent
Which ICS ?
• Many factors to look at:
– Delivery system (nebulizer, MDI, DPI, propellant,
built -in spacer)
– Lung deposition
Q Va
rt– Potency of molecule
o
r
c – Systemic effects
i
m
l
– Length of experience in children
Pu
– Growth studies
– Taste/acceptability
– Cost/formulary
rt
Azmaco
19
ICS’s: particle size and % lung deposition
Inhaled Steroid
Particle Size
(µm)
Lung Deposition
(%)
HFA Beclomethasone (QVar)
1.1
56
HFA Ciclesonide (Alvesco)
1.0
52
HFA Flunisolide (Aerobid HFA)
1.2
68**
Budesonide DPI (Pulmicort)
2.6
32
CFC – Beclomethasone (Vanceril)
3.5
10-15
CFC – Flunisolide (Aerobid)
3.8
15-20
CFC – Triamcinolone (Azmacort)
4.5
14
Fluticasone DPI (Flovent)
5.4
15
Adapted from Leach CL. Respir Care 2005; Martin RJ, et al. J Allergy Clin Immunol 2002.
24
Comparison of lung deposition
in same subject
Leach CL et al. Am J. Respir Crit Care Med. 2000;161(3): A34.
20
Using ICS’s wisely
• Use step-down approach (“lowest effective dose”)
– Low doses work
• BDP (Q Var) 100-300 ug/day (40 mcg, 80 mcg strengths)
• Fluticasone (Flovent) 100-300 ug/day (44 mcg, 110 mcg strengths)
• Budesonide (Pulmicort) 360-540 ug/day (90 mcg, 180 mcg strengths)
(or, 0.5 – 1.0 mg/day)
• Start BID; consolidate to QD dosing if possible
• Monitor (q 4-6 wks then 3 mos then 6 mos): the
3 C’s
– Compliance
– Control
– Competency (inhaler technique)
• Anticipate steroid phobia!
Steroid phobia:
4 bases to cover for
a “home run”
1. Different from other types
•
•
anabolic
oral
2. Spares systemic exposure
•
Topical acting
3. Low dose
4. Lots of experience (1970’s)
Welch Pediatric Annals 1998
21
Bad inhaler technique rampant!
Spacers don’t solve it!!
Scarfone et al Arch Ped Adol Med 2002
• Kids with acute asthma presenting to ER
• MDI technique assessed
• Nearly half performed multiple steps wrong
• As many mistakes made with a spacer as without
Lesson:
spacers don’t solve everything!!
Is this your patient?
22
Please, pretty pretty please….
Don’t even think about increasing
medication dose until you have:
– Assessed compliance
– Checked inhaler technique
Classification of asthma severity
(children 0-4 years of age)
Components of Severity
Impairment
NHLBI 2007
Persistent
Intermittent
Mild
Moderate
Severe
Symptoms
<2 days/week
>2 days/week but
not daily
Daily
Throughout
the day
Nighttime awakenings
0
1-2x/month
3-4x/month
>1x/week
<2 days/week
>2 days/week but
not daily
Daily
Several times
per day
None
Minor limitation
Some
limitation
Extremely
limited
Short-acting beta2agonists use for
symptom control (not
prevention of EIB)
Interference with
normal activity
>2 exacerbations in 6 mos requiring oral steroids, or
0-1/year
Risk
Exacerbations (consider
frequency and severity)
>4 wheezing episodes/1 year lasting >1 day AND
risk factors for persistent asthma
Frequency and severity may fluctuate over time
Exacerbations of any severity may occur in patients in any severity
category
23
Risk factors for asthma –
asthma predictive index (API)
“Rule of 3 plus”
Tucson Children’s Longitudinal Respiratory Study
• Recurrent wheezing (> 3 episodes/yr) in 1st 3 yrs of life–
who goes on to have asthma?
• Major criteria – parental asthma, eczema
• Minor criteria – allergic rhinitis, eosinophilia,
wheezing without colds
• 1 major or 2 minor – about 80% had persistent
asthma at later period (between ages 6-13)
Castro-Rodriguez JA et al. Am J Respir Crit Care Med. 2000;162:1403-1406.
NEW
6 steps of therapy (0-4 yrs)
Persistent Asthma: Daily Medication
Intermittent
Asthma
Level 4
Level 3
Step 5
Step 4
Level 2
Step 3
Preferred:
High-dose
ICS
Preferred:
Mediumdose ICS
AND
Mediumdose ICS
AND
Step 2
Level 1
Step 1
Preferred:
SABA prn
Preferred:
Low-dose
ICS
Alternative:
montelukast
or cromolyn
Preferred:
Either:
montelukast
or LABA
Either:
montelukast
or LABA
Step 6
Preferred:
High-dose
ICS
AND
Either:
montelukast
or LABA
AND
oral
corticosteroids
Step up if
needed
(first, check
adherence and
environmental
control)
Assess
control
Step down if
possible
(and asthma is
well controlled
at least 3
months)
Patient Education and Environmental Control at Each Step
NHLBI 2007
24
3 – 6 yrs
0 to 3-4 yrs
Age appropriate
device!!!!
5 and older
Nebulizer versus MDI with spacer
for the little ones?
25
Clinical score % fall from baseline
Albuterol by nebulizer vs MDI/spacer in
Group I - Wet INH
wheezy children
0
Group II - Spacer
N = 42 total (19 neb, 23 MDI)
• x age = 16 mos (10 mos – 4 yrs)
-5
• albuterol (q 20’ x 3):
4 p (Nebuchamber with mask)
-10
-15
0.5 ml (Aeromist nebulizer*)
Rx given every 20’
Randomly assigned, double dummy, DB
-20
-25
31% of all
pts hx’ed
NO DIFFERENCE
-30
0 min
20 min
40 min
60 min
*no mention of use of mask
Time from baseline
Mandelberg A, et al. Is nebulized aerosol treatment necessary in the pediatric emergency department?
Chest 2000;117:1309-1313.
Summary of ICS with spacer/mask studies
in young children
8 studies total – all with FP
• 6 non-US
• Age : 0.5 - 4 yrs (most 1-3 yrs)
• Spacer: 4 not available in US (Babyhaler); 3 Aerochamber; 1 ?
Duration: Most (5/8): 1-6 mos; 3 studies: 1-3 yrs
• Dose: 88 – 250 ugm/day (most around 200 ugm)
• Efficacy:
– Symptoms/exacerbations: 5/8 improved (2/8 not)
– Lung fctn: 2/5 improved (3/5 not)
• 2 no improvement in symptoms or lung function
– eNO: 1/1 reduced but not lung fctn or symptoms
– Lower dose not as effective (2/2)
• Safety:
– 2/6 showed growth suppression
– 1/2 showed HPA suppression
IT WORKS!!
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Suggestions for MDI/spacer/mask
• Use proper valved holding chamber
– Appropriate size mask
– Aerochamber Plus (or Aerochamber Max)
•
•
•
•
•
Child psychology needed
Do not under-dose
Patient education/re-education essential
Proper care of spacer
Graduate off mask when able to
New definition of
asthma?
____________________
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New definition of asthma:
A deficiency of Advair
Symbicort
Dulera
Serevent (salmeterol)
Foradil (formoterol
Advair (FP/sal)
Symbicort (bud/form)
*Dulera (mom/form)
Black Box Warning
WARNING: Data from a large placebo-controlled US study
that compared the safety of salmeterol (SEREVENT®
Inhalation Aerosol) or placebo added to usual asthma therapy
showed a small but significant increase in asthma-related
deaths in patients receiving salmeterol ……….
* Newest 8/2010
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Total Number of Prescriptions
US prescriptions for salmeterol and
salmeterol-containing products
25,000,000
20,000,000
15,000,000
10,000,000
5,000,000
Salmeterol
20
05
20
04
20
03
20
02
20
01
20
00
19
99
19
98
19
97
19
96
19
95
19
94
0
Sal/FP
Source: Vector One: National (VONA) from Verispan.
.
Number of asthma deaths* in US,
1979-2004
Number of Asthma Deaths
6000
5000
**Salmeterol
4000
**Sal/FP
3000
2000
1000
2003
2001
1999
1997
1995
1993
1991
1989
1987
1985
1983
1981
1979
0
*1979-1998 rates reflect the International Classification of Disease, 9th Revision Code 493. 1999-2004 rates reflect the ICD
10th Revision Codes.
1.
2.
3.
American Lung Association Epidemiology & Statistics Unit Research And Scientific Affairs. Trends in Asthma Morbidity and
Mortality. May 2005. Available at: www.lungusa.org. Accessed June 14, 2006.
National Vital Statistics Report. Deaths: Final Data for 2003. April 2006. Available at www.cdc.gov. Accessed June 14, 2006.
National Vital Statistics Report. Deaths: Preliminary Data for 2004. June 2006. Available at www.cdc.gov. Accessed June 29,
2006.
29
Use of LABA/ICS
(e.g. FP/sal (Advair), bud/form (Symbicort), mom/form (Dulera))
•
•
•
•
•
Appropriate: moderate (or higher) severity
LABA’s never used alone
African-Americans at most risk?
Kids particularly benefit from LABA
Step-down to monotherapy when able to
Ideas for change
(did you get the point?)
I promise to:
The “end”
• classify severity, but as important, monitor control
(e.g. ACT)
• remember the API and use it
• use an age-appropriate asthma device
• teach/re-teach inhaler/spacer/nebulizer technique
• use ICS’s; deal head-on with steroid phobia
• use the “step- down” med approach
• not fear LABA/ICS’s
30
Case for Audience Response
Correct answer
Jimmy, 7 y.o. on ICS rx for persistent asthma,
still needing albuterol 3d/week, and in ER last month
You are seeing him today.
What is the most important thing to do?
1. Change to a different ICS product
2. Check his medication adherence/inhaler
technique
3. Question the dx of asthma, and do further tests
4. Add a 2nd controller med or increase ICS dose
Case for Audience Response
Jimmy, 7 y.o. on ICS rx for persistent asthma, still needing albuterol 3d/week,
and in ER last month for flareup.
You are seeing him today. What are the most important things to do?
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Check his medication adherence
Check his inhaler technique
Add a 2nd controller med
Increase his ICS dose
Change to a different ICS product
Work him up for GE reflux
Get a CXray
Talk to parents about their feelings regarding ICS’s
Change his ICS to a nebulizer form
Do RAST testing for food allergy
Do an objective test for control of asthma
31