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Arch
Bronconeumol.
2011;
47(10)
:482–487
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Original
Article
Changes
in
Clinical,
Pulmonary
Function,
Quality
of
Life
and
Costs
in
a
Cohort
of
Asthmatic
Patients
Followed
for
10
Years

J.
Serra
Batlles,
a
,
V.
Plaza,
b
A.
Comella
c
a
Unidad
de
Neumología,
Hospital
General
de
Vic,
Vic,
Barcelona,
Spain
b
Servicio
de
Neumología,
Hospital
de
la
Santa
Creu
y
San
Pau,
Barcelona,
Spain
c
Departamento
de
Ciencias
y
Ciencias
Sociales,
Universidad
de
Vic,
Barcelona,
Spain
a
r
t
i
c
l
e
i
n
f
o
Article
history:
Received
25
November
2010
Accepted
31
May
2011
Keywords:
Asthma
Lung
function
Quality
of
life
Pharmacoeconomics
Asthma
evolution
a
b
s
t
r
a
c
t
Few
studies
have
comprehensively
assessed
the
evolution
of
asthma
disease
in
recent
years.
Objectives:
To
determine
changes
in
morbidity,
lung
function
and
quality
of
life
and
to
establish
the
impact
in
terms
of
cost
in
a
cohort
of
patients
with
asthma.
Methods:
Prospective,
descriptive
and
realistic
study
that
included
220
asthma
patients
evaluated
10
years
after
their
inclusion
(1994–2004).
For
all
the
patients,
data
for
symptoms,
lung
function,
quality
of
life
and
financial
cost
were
collected.
Results:
There
was
a
decrease
in
the
frequency
of
health
service
visits,
including:
emergency
room
visits
for
asthma
exacerbations,
0.3
(0.9)
versus
0.6
(1)
visits
per
patient
per
year
(
P
=.003);
a
reduction
in
the
severity
of
the
disease,
with
a
greater
proportion
of
patients
with
mild
asthma,
121
(54.8%)
versus
94
(42.7%)
(
P
=.001);
a
decrease
(improvement
in
quality
of
life)
in
the
total
SGRQ,
30.1
(16.5)
versus
37
(19.6)
(
P
<.001);
and
reduced
total
costs,
1464
D
(3415.8)
compared
to
2267
D
(4174)
per
patient/year
(
P
<.001),
mainly
due
to
indirect
costs,
617.50
D
(2855.9)
compared
to
1320.10
D
(3685.3)
per
patient/year
(
P
=.001).
When
assessing
the
changes
observed
according
to
asthma
severity,
no
differences
were
observed
between
groups.
Conclusions:
The
evolution
of
the
morbidity
and
quality
of
life
of
asthma
patients
between
1994
and
2004
are
clearly
favorable.
This
improvement
provided
a
significant
reduction
in
the
total
costs
of
disease
treatment.
©
2010
SEPAR.
Published
by
Elsevier
España,
S.L.
All
rights
reserved.
Cambios
en
la
clínica,
la
función
pulmonar,
la
calidad
de
vida
y
los
costes
en
una
cohorte
de
pacientes
asmáticos
seguidos
durante
10
a
̃
nos
Palabras
clave:
Asma
Función
pulmonar
Calidad
de
vida
Farmaeconomía
Evolución
del
asma
r
e
s
u
m
e
n
Son
escasos
los
estudios
que
han
evaluado
de
forma
global
la
evolución
de
la
enfermedad
asmática
en
los
últimos
a
̃
nos.
Objetivos:
Determinar
los
cambios
en
la
morbilidad,
la
función
pulmonar
y
la
calidad
de
vida,
y
establecer
el
impacto,
en
términos
económicos,
de
una
cohorte
de
pacientes
con
asma.
Método:
Estudio
prospectivo,
realístico
y
descriptivo
que
incluyó
220
asmáticos
evaluados
a
los
10
a
̃
nos
de
su
inclusión
(1994–2004).
Se
recogieron
datos
clínicos,
de
función
pulmonar,
de
calidad
de
vida
y
de
costes
económicos.
Resultados:
Se
observó
un
descenso
en
la
frecuentación
de
los
servicios
sanitarios,
entre
otros
el
de
las
visitas
en
urgencias
por
exacerbación
asmática,
0,3
(0,9)
por
0,6
(1)
visitas
por
paciente/a
̃
no
(p
=
0,003);
una
reducción
de
la
gravedad
de
la
enfermedad,
con
una
mayor
proporción
de
pacientes
con
asma
leve,
121
(54,8%)
frente
a
94
(42,7%)
(p
=
0,001);
un
descenso
(mejoría
de
la
calidad
de
vida)
en
la
puntuación
total
del
cuestionario
de
St.
Georges,
30,1
(16,5)
frente
a
37
(19,6)
(p
<
0,001),
y
una
reducción
de
los
costes
totales,
1.464
D
(3.415,8)
por
2.267
D
(4.174)
paciente/a
̃
no
(p
<
0,001),
fundamentalmente
a
expen-
sas
de
los
costes
indirectos,
617,5
D
(2.855,9)
frente
a
1.320,1
D
(3.685,3)
paciente/a
̃
no
(p
=
0,001).
Al
considerar
los
cambios
observados
en
función
del
nivel
de
gravedad,
no
se
constataron
diferencias
entre
los
grupos,
mejorando
todos
por
igual.

Please
cite
this
article
as:
Serra
Batlles
J,
et
al.
Cambios
en
la
clínica,
la
función
pulmonar,
la
calidad
de
vida
y
los
costes
en
una
cohorte
de
pacientes
asmáticos
seguidos
durante
10
a
̃
nos.
Arch
Bronconeumol.
2011;47:482–7.
Corresponding
author.
E-mail
address:
jserra@chv.com
(J.
Serra
Batlles).
1579-2129/$
see
front
matter
©
2010
SEPAR.
Published
by
Elsevier
España,
S.L.
All
rights
reserved.
J.
Serra
Batlles
et
al.
/
Arch
Bronconeumol.
2011;
47(10)
:482–487
483
Conclusiones:
La
evolución
de
la
morbilidad
y
de
la
calidad
de
vida
de
los
pacientes
con
asma
entre
1994
a
2004
a
̃
nos
es
notoriamente
favorable.
Dicha
mejora
se
traduce
en
una
importante
reducción
de
los
costes
económicos
ocasionados
por
la
enfermedad.
©
2010
SEPAR.
Publicado
por
Elsevier
España,
S.L.
Todos
los
derechos
reservados.
Introduction
According
to
the
World
Health
Organization,
asthma
is
the
sev-
enth
most
prevalent
disease
in
the
world,
affecting
more
than
300
million
people.
It
is
a
chronic
respiratory
disease
that
affects
all
age
groups,
from
newborns
to
the
elderly.
In
Spain,
although
there
is
certain
variability
depending
on
the
geographical
area
con-
sidered,
it
is
estimated
that
around
4%
of
the
adult
population
is
affected.
1,2
In
addition,
due
to
causes
that
have
not
been
well
estab-
lished,
said
prevalence
has
increased
considerably
in
recent
years,
particularly
in
economically
developed
countries.
3
All
these
log-
ically
result
in
a
great
consumption
of
health-care
resources.
In
some
countries,
the
diagnostic
and
therapeutic
management
of
the
disease
represents
between
1%
and
2%
of
total
health-care
service
expenses.
4
These
pessimistic
numbers
are
countered
by
others
that
are
more
positive.
Recent
data
on
the
disease
confirm
a
notable
reduc-
tion
in
mortality
as
well
as
in
frequency
of
hospital
care
due
to
asthma.
5,6
It
is
considered
that
the
causes
of
said
reduction
could
be
related
with
the
possible
improvement
in
the
attention
given
by
health-care
professionals,
5
the
extensive
diffusion
and
the
impact
of
the
guidelines
for
clinical
practice
in
asthma,
7,8
and
particu-
larly
by
the
greater
use
of
inhaled
corticosteroids.
9
In
addition
to
the
favorable
effects
of
this
group
of
drugs,
we
must
also
take
into
account
the
appearance
of
the
new
formulations
of
the
last
15–20
years:
long-acting

2
-adrenérgic
agonists
combined
in
one
single
inhaler
with
corticosteroids,
10
and
also
leukotriene
receptor
antagonists.
Nevertheless,
there
is
limited
information
available
on
the
recent
natural
history
of
asthma
in
standard
clinical
practice.
Specifically,
in
our
setting
there
are
no
longitudinal
studies
in
significant
patient
samples
analyzing
the
predictable
changes
in
morbidity
and
quality
of
life
over
the
last
20
years.
Along
the
same
lines,
there
are
no
studies
that
have
evaluated
the
impact
that
the
possible
changes
in
morbidity
and
new
treatments
could
have
on
the
total
costs
of
the
disease.
In
said
context,
the
cohort
of
patients
known
as
“asthma
in
Osona”
represents
the
ideal
framework
for
responding
to
the
ques-
tions
posed.
This
group
of
patients,
who
have
been
followed
up
without
interruption
by
the
same
group
of
professionals
for
twenty
years,
have
provided
valuable
information
in
the
past
about
dif-
ferent
clinical
and
economic
aspects
related
with
the
disease.
11,12
From
this
standpoint,
the
objective
of
the
present
study
was
to
determine,
in
the
mentioned
patient
cohort,
the
magnitude
of
the
evolutionary
changes
in
their
disease
in
terms
of
morbidity
and
mortality,
lung
function,
quality
of
life
and
costs
during
the
ten-year
period
from
1994
to
2004.
Materials
and
Methods
A
prospective,
longitudinal,
descriptive,
realistic
study
designed
in
order
to
determine
changes
in
morbidity
and
mortality,
lung
function,
quality
of
life
and
the
costs
of
a
cohort
of
patients
with
asthma
observed
for
10
years
(1994–2004).
It
was
carried
out
in
the
district
of
Osona,
a
semi-rural
area
in
the
province
of
Barcelona
(Spain),
with
some
150,000
inhabitants.
The
study
protocol
was
approved
by
the
Clinical
Research
Ethics
Committee
of
the
Hos-
pital
General
de
Vic,
and
all
the
patients
granted
their
consent
to
participate.
n=333
Inicial Phase – 1994
n=220
Final Phase – 2004
n=21
(exitus
)
n=56
(not located)
n=9
(refused to
participate)
n=27
(severe
deterioration
in health)
Figure
1.
Flowchart
of
the
cases
lost
to
follow-up
over
the
course
of
the
10-year
study.
The
study
entails
a
follow-up
of
a
patient
cohort
with
asthma
whose
methods
have
been
previously
published.
11,12
Briefly,
the
patients
included
were
over
the
age
of
14
and
diagnosed
with
asthma
according
to
the
ATS
criteria.
13
Their
disease
intensity
was
classified
according
to
initial
severity
(1992
NIH
Consensus).
14
The
patients
were
seen
routinely
at
the
primary-care
level
and
once
a
year
at
the
outpatient
consultations
of
the
pneumology
depart-
ment
of
the
hospital,
where
the
degree
of
control
was
determined
and
the
treatment
adjusted.
Out
of
the
330
patients
initially
evaluated
in
phase
I
(1994),
220
(66.7%)
were
evaluable
in
phase
II
(2004).
The
causes
of
the
110
losses
are
compiled
in
Fig.
1
.
For
the
patients
who
had
died
over
the
follow-up
period,
the
cause
of
death
was
determined
by
means
of
family
interview
and
review
of
the
patient
medical
files
and
reports.
Out
of
a
total
of
220
patients
who
were
evaluable
in
the
end,
both
in
phase
I
(1994)
as
well
as
in
phase
II
(2004),
the
following
data
were
compiled
and
grouped
into
four
categories:
Clinical
symptoms
and
morbidity
caused
by
asthma
during
the
previous
year:
number
of
visits
to
the
primary
care
physician,
vis-
its
to
the
emergency
room,
hospitalizations,
days
of
absenteeism
from
work,
short
cycles
of
oral
steroids
and
standard
maintenance
treatment
received.
The
information
was
obtained
both
from
the
patient
as
well
as
from
the
medical
files.
Spirometric
flow
by
means
of
spirometry
(Datospir-92,
Sibelmed,
Barcelona,
Spain)
before
and
after
the
administration
of
inhaled
salbutamol.
15
Quality
of
life,
determined
with
the
supervised
completion
of
the
Spanish
version
of
the
St.
George’s
Respiratory
Questionnaire
(SGRQ).
16,17
Economic
costs,
using
a
specially
designed
questionnaire
that
compiled
the
direct
costs
(medication,
office
visits,
emergency
room
visits,
hospitalizations
and
complementary
tests)
and
indi-
rect
costs
(missed
work,
invalidity)
caused
by
the
disease
in
the
year
prior
to
the
data
collection.
The
economic
costs
ten
years
later
were
updated
in
accordance
with
the
Finance
Department
of
the
Hospital
General
de
Vic,
and
484
J.
Serra
Batlles
et
al.
/
Arch
Bronconeumol.
2011;
47(10)
:482–487
70
60
50
40
30
20
10
0
Mild
Moderate
Severe
Phase I
Phase II
P
>.05
P
<.001
P
=.001
%
Figure
2.
Distribution
of
the
levels
of
asthma
severity
of
the
patients
analyzed
in
phase
I
(1994)
and
II
(2004)
of
the
study.
the
days
of
work
missed
and
disability
were
based
on
the
data
from
the
National
Institute
of
Statistics
(
Instituto
Nacional
de
Estadística
INE
).
18,19
In
both
phases
of
the
study,
the
same
researcher
(AC)
was
in
charge
of
interviewing
the
patients,
performing
the
spirometries
and
administering
the
SGRQ.
Statistical
Analysis
A
descriptive
analysis
was
completed
for
the
variables
collected
from
both
phases
of
the
study.
The
values
were
expressed
as
means
and
standard
deviation
(SD)
or,
if
necessary,
as
number
of
cases
with
their
percentage.
The
results
of
the
three
asthma
severity
groups
were
compared
using
the
(
2
or
Fisher’s
exact
test
for
the
qualitative
variables,
or
rather
with
the
Kruskal–Wallis
test
for
the
quantitative
variables,
depending
on
their
distribution.
The
changes
observed
between
the
two
phases
were
expressed
as
a
difference
between
the
means
and
were
analyzed
with
the
Wilcoxon
test
for
the
quanti-
tative
variables;
for
the
qualitative
variables,
the
McNemar
test
was
used.
The
Kolmogorov–Smirnov
test
was
used
to
check
whether
the
distribution
of
a
variable
could
be
considered
normal
or
not.
The
differences
with
a
P
-value
<.05
were
considered
statistically
signif-
icant.
The
information
compiled
was
input
after
double-checking
and
was
analyzed
in
a
database
with
SPSS
version
12
software
(SPSS-PC,
Chicago,
IL,
USA).
Results
During
the
10-year
follow-up
of
the
cohort,
21
(6.3%)
of
the
patients
evaluated
at
the
beginning
had
died.
Only
one
case
of
death
was
caused
by
a
fatal
asthma
episode.
The
causes
of
the
remain-
ing
deaths
were:
eight
cases
of
neoplasm
(three
gastrointestinal,
two
pulmonary,
one
urinary,
one
bone
and
one
of
undetermined
neoplastic
etiology);
five
due
to
cardiovascular
diseases
(two
cerebrovascular
accidents,
two
refractory
heart
failures
and
one
myocardial
infarction);
four
due
to
severe
respiratory
infections;
one
due
to
evolved
hepatic
cirrhosis;
another
due
to
biliary
sepsis,
and
finally
one
more
due
to
trauma
(traffic
accident).
Fig.
2
shows
the
distribution
of
asthma
severity
in
both
phases.
When
we
compared
the
proportion
of
the
different
levels
of
sever-
ity
between
both
determinations,
we
observed
that
in
151
(69%)
patients
there
were
no
changes,
46
(21%)
improved
and
23
(10%)
worsened.
However,
when
the
said
changes
were
considered
as
a
whole,
there
was
a
confirmed
improvement
in
general
asthma
severity
10
years
later,
with
a
significantly
greater
proportion
of
patients
with
mild
asthma
and
a
reduction
of
moderate
asthma
in
phase
II
compared
with
asthma
in
phase
I.
Table
1
compiles
the
results
of
the
220
(142
[64.5%]
women)
patients
followed
during
the
10
years.
The
comparison
between
both
phases
revealed
a
general
improvement
in
phase
II
(2004)
compared
with
phase
I
(1994).
Thus,
among
the
clinical
and
mor-
bidity
variables
for
asthma
during
the
previous
year,
there
was
a
significant
reduction
in
the
number
of
office
visits
in
primary
care,
specialized
care
and
the
emergency
department
as
well
as
the
number
of
missed
work
days.
At
the
same
time,
the
use
of
inhaled
corticosteroids
increased
significantly
and
the
use
of
their
combi-
nation
with
long-acting
(
2
-adrenergic
agonists
was
introduced:
in
2004,
21%
of
the
patients
were
receiving
them,
while
in
1994
none
received,
as
the
drug
was
not
being
commercialized
still
(data
not
shown
in
Table
1
).
The
total
SGRQ
score
was
significantly
lower
and,
therefore,
quality
of
life
improved.
In
contrast
with
the
earlier
results,
there
was
an
observed
non-significant
decline
in
the
mean
FEV
1
.
The
economic
expense
analysis
showed
statistically
signif-
icant
changes
in
the
reduction
of
the
total
costs,
both
direct
and
indirect.
Except
for
the
expenses
incurred
due
to
the
purchase
of
medication
and
primary-care
office
visits,
both
of
which
increased,
the
rest
of
the
different
categories
that
make
up
the
direct
costs
(except
those
caused
by
blood
analyses,
which
remain
unchanged)
were
significantly
reduced.
With
the
aim
of
evaluating
the
possible
different
magnitude
in
the
changes
observed
between
the
two
phases
of
the
study
according
to
the
level
of
asthma
severity,
the
sample
analyzed
was
subdivided
into
the
three
levels
of
severity
proposed
in
the
Inter-
national
Asthma
Consensus
of
the
NIH
in
1992:
mild,
moderate
and
severe
asthma.
14
In
order
to
avoid
possible
confusion
in
the
grouping
of
the
cases,
we
excluded
from
the
following
analysis
those
patients
who
had
changed
in
level
of
severity
in
phase
II.
Therefore,
in
the
end
we
evaluated
with
the
defined
criteria
only
those
data
obtained
from
the
151
patients
who
did
not
change
in
asthma
severity
over
the
course
of
the
entire
study.
Table
2
shows
in
each
severity
group
the
difference
of
the
means
between
phase
I
(1994)
and
phase
II
(2004)
of
the
variables
analyzed
in
the
151
patients
mentioned.
The
analysis
verifies
the
improvement
of
the
results
of
the
variables
studied
in
each
one
of
the
three
lev-
els
of
severity,
with
negative
values
as
the
general
morbidity
and
costs
declined
between
the
two
phases.
And,
although
in
some
vari-
ables
(primary
care
physician
visits,
short
cycles
of
corticosteroids,
work
absenteeism,
SGRQ
and
indirect
costs)
there
is
a
tendency
towards
a
greater
reduction
(or
improvement)
in
severe
asthma,
when
compared
with
mild
or
moderate
asthma,
only
days
of
work
absenteeism
reached
statistical
significance.
Discussion
The
main
contribution
of
the
present
study
is
the
confirmation
that
the
clinical
evolution
of
asthmatic
disease
in
recent
years
is
notoriously
favorable,
with
a
significant
reduction
in
morbidity,
an
improvement
in
the
quality
of
life
of
the
patients
and
a
substan-
tial
reduction
in
total.
Also,
these
changes
are
independent
from
the
initial
level
of
severity,
even
including
the
severest
forms
of
the
disease.
The
improvement
coincides
with
the
increased
use
of
inhaled
corticosteroids,
the
introduction
of
the
combinations
of
corticosteroids
and
long-acting
(
2
-adrenergic
agonists,
and
pre-
sumably
(as
they
coincide
in
time)
with
the
publishing
of
clinical
practice
guidelines.
7,14
Furthermore,
it
is
important
to
highlight
the
dimension
of
the
changes
observed,
which
provided
a
consider-
able
reduction
(50%)
in
the
rate
of
emergency
department
visits
and
hospitalizations
and
a
decline
of
7
points
in
the
SGRQ,
with
a
tendency
towards
being
more
notable
in
the
moderate
and
severe
disease
types.
Consequently,
there
was
a
spectacular
reduction
in
the
number
of
days
of
work
absenteeism
associated
with
asthma.
In
general,
the
results
concur
with
those
observed
in
other
international
studies
with
similar
designs.
5,20
Among
these
are
the
so-called
“Finnish
experience”
(The
Finnish
Asthma
Programme),
in
which,
after
the
implementation
of
an
ambitious
nation-wide
J.
Serra
Batlles
et
al.
/
Arch
Bronconeumol.
2011;
47(10)
:482–487
485
Table
1
Clinical
Treatment
and
Morbidity
of
Asthma,
Lung
Function,
Quality
of
Life
and
Costs
Compiled
in
Phase
I
(1994)
and
in
Phase
II
(2004)
of
the
Study.
Phase
I
(1994)
(n
=
220)
Phase
II
(2004)
(n
=
220)
P
-Value
Age,
years
42.6
(17)
52.6
(16.8)
Smoker,
n
(%)
28(12.8%)
26
(11.9%)
NS
Asthma
symptoms
and
morbidity
Asthma
severity,
n
(%)
Mild
94
(42.7)
121
(54.8)
.001
Moderate
76
(34.5)
48
(21.9)
Severe
50
(22.7)
51
(23.3)
Visits
to
the
primary-care
physician
a
3.1
(3.3)
1.8
(3.2)
<.001
Visits
to
the
specialist
a
0.9
(1.0)
0.6
(1.04)
<.001
Visits
to
emergency
a
0.6
(1.0)
0.3
(0.9)
.003
Hospitalizations
a
0.2
(0.4)
0.1
(0.4)
NS
Patients
with
inhaled
corticosteroids,
%
130
(59.1%)
143
(65%)
.03
Cycles
of
oral
corticosteroids
a
0.8
(1.5)
0.6
(1.09)
NS
Number
of
days
of
work
missed
and
year
a
42.4
(9.13)
3.3
(17.9)
<.001
Spirometry
FEV
1
,
%
reference
value
78.3
(22.5)
76.6
(22.6)
NS

FEV
1
postBD
b
7
(10.7)
8
(9.5)
NS
Quality
of
life
(SGRQ)
Total
score
37
(19.6)
30.1
(16.5)
<.001
Economic
cost
(annual
cost
per
patient
in
Euros)
Direct
costs
946
(1197.6)
829.3
(1110.1)
.04
Medications
423.3
(347.4)
592.6
(685.8)
.03
Visits
to
the
primary
care
physician
14.8
(15.8)
40.1
(72.4)
<.001
Visits
to
the
specialist
121.9
(195.6)
31.6
(59.5)
<.001
Hospitalizations
290.1
(903)
127.9
(622.7)
.02
Emergency
services
51.9
(93.7)
40.9
(105.6)
NS
Spirometry
9.8
(12.6)
5.2
(9.4)
<.001
Blood
analysis
1.5
(1.9)
2.9
(7.3)
NS
Prick
test
18
(35.5)
1.4
(6.3)
<.001
Chest
radiography
15.3
(18.8)
4.3
(13.3)
<.001
Indirect
costs
1320.1
(3685.3)
617.5
(2855.9)
.001
Total
costs
2266.8
(4174)
1464.4
(3415.8)
<.001
Values
expressed
in
means
(standard
deviation),
except
when
indicated
in
the
table
as
number
of
cases
(percentage).
a
Number
of
asthma
episodes
per
patient
during
the
previous
year.
b
(FEV
1
postBD:
increase
in
the
percentage
over
baseline
FEV
1
after
the
inhalation
of
a
bronchodilator
(salbutamol).
SGRQ:
St.
George’s
Respiratory
Questionnaire.
program,
they
confirmed
10
years
after
its
application
(1993–2003)
a
significant
and
considerable
reduction
in
morbidity
and
mortality
(particularly
in
severe
exacerbations,
hospitalizations
and
death)
and
total
costs.
5
Recent
national
21,22
and
international
23
studies
have
consis-
tently
demonstrated
that
only
between
33%
and
55%
of
the
patients
with
asthma
are
appropriately
controlled.
A
priori
,
the
satisfactory
results
of
our
study
could
go
against
the
widespread
opinion
of
the
current
insufficient
control
of
asthma.
The
explanation
of
the
sup-
posed
incongruence
between
both
affirmations
lies
in
the
fact
that,
although
therapeutic
improvements
have
provided
a
substantial
reduction
in
morbidity
and
mortality
and
an
improvement
in
the
quality
of
life
of
the
patients,
they
have
not
been
able
to
promote
a
less-demanding
morbidity,
such
as
that
of
well-controlled
asthma.
This
circumstance
could
possibly
be
related
with
the
limited
use
of
educational
programs.
A
survey
carried
out
in
Spain
that
inter-
viewed
more
than
1000
physicians
and
nurses,
who
are
usually
involved
in
the
follow-up
of
asthma
patients,
revealed
that
only
16%
of
those
interviewed
declared
that
a
standardized,
structured
education
program
was
used
in
their
health-care
centers.
24
Observations
made
in
large
patient
samples
or
by
using
meta-analyses
of
clinical
trials
associated
the
use
of
long-acting
(
2
-adrenergic
agonists
with
an
infrequent
but
significantly
greater
risk
of
death
and
severe
exacerbations.
25,26
With
said
premise,
our
study
should
have
identified
an
increase
(or
at
least
not
show
changes)
in
exacerbations
and
hospitalizations,
as
one-fifth
of
the
sample
analyzed
(21%)
were
taking
them
in
phase
II
(2004),
com-
pared
with
phase
I
(1994)
when
no
patients
were.
Contrarily,
a
significant
reduction
was
observed
in
said
parameters,
even
in
the
severest
patients.
These
results
agree
with
the
growing
opin-
ion
contrary
to
the
supposed
deleterious
effect
of
long-acting
(
2
-adrenergic
agonists
27
and
are
in
tune
with
another
study
recently
done
in
our
setting.
10
Among
the
results
of
the
study,
we
found
striking
the
non-
significant
decline
in
mean
FEV
1
(
1.3%)
observed
when
comparing
the
two
phases.
This
reduction
contrasts
with
the
favorable
results
observed
in
the
rest
of
the
clinical
variables
analyzed.
Neverthe-
less,
it
is
well-known
that
the
asthmatic
population
experiences
an
accelerated
progressive
loss
in
lung
capacity
compared
with
the
non-asthmatic
population.
10
This
deterioration
is
only
partially
prevented
by
corticosteroid
treatment,
which
evidently
differs
with
the
beneficial
action
that
said
drugs
have
on
clinical
variables
or
indicators.
28
On
the
other
hand,
a
greater
loss
in
lung
function
has
been
associated
with
patients
who
suffer
frequent
asthma
exacerbations,
a
circumstance
attributed
to
the
phenomenon
of
bronchial
remodeling
that
accompanies
the
exacerbation.
29
Along
this
line,
we
should
indicate
that
our
study,
in
agreement
with
others,
20
verified
a
non-significant
tendency
in
the
mild
asthma
group
towards
preserving
FEV
1
(0.3%)
compared
with
the
decline
observed
in
those
with
moderate
and
severe
asthma
(
4.2
and
1.1%,
respectively).
Moreover,
these
are
groups
that
presented
a
greater
tendency
towards
exacerbations
(visits
to
emergency
and
hospitalization)
due
to
asthma.
The
analysis
of
the
economic
data
of
the
study
revealed
that,
in
agreement
with
the
lower
morbidity
and
particularly
the
decline
in
hospital
care,
the
total
costs
decreased
significantly.
The
mean
of
the
total
cost
per
patient
registered
in
2004
represented
a
decrease
of
35%
over
the
average
of
1994.
These
data
are
equivalent
to
that
486
J.
Serra
Batlles
et
al.
/
Arch
Bronconeumol.
2011;
47(10)
:482–487
Table
2
Comparison
of
the
Magnitude
of
the
Changes
Observed
at
Each
Level
of
Asthma
Severity
in
the
two
Phases
of
the
Study.
Differences
in
the
Averages
Between
Phase
I
(1994)
and
Phase
II
(2004)
of
the
Clinical
and
Morbidity
Variables
of
Asthma,
Lung
Function,
Quality
of
Life
and
Costs
for
the
151
Patients
that
did
not
Vary
in
Severity
Level
Between
Phases.
Mild
Asthma
(n
=
84)
Moderate
Asthma
(n
=
30)
Severe
Asthma
(n
=
37)
P
-Value
Demographic
data
Age,
years
43.2
(40;
46.4)
55.9
(50;
61.3)
66.7
(62.8;
70.6)
<.001
Women,
n
(%)
51
(59.5)
23
(76.7)
23
(59.5)
.006
Smoker,
n
(%)
17
2
1
NS
Asthma
clinical
treatment
and
morbidity
Visits
to
the
primary
care
physician
a
1.5
(
2.0;
1.0)
0.7
(
2.3;
0.9)
1.5
(
2.9;
0.1)
NS
Visits
to
the
specialist
a
1.1
(
1.4;
0.8)
2.1
(
4.2;
0.0)
1.4
(
2.5;
0.3)
NS
Visits
to
emergency
a
0.3
(
0.4;
0.2)
0.5
(
1.2;
0.2)
0.3
(
0.8;
0.2)
NS
Hospitalizations
a
0.1
(
0.3;
0.1)
0.2
(
0.4;
0.0)
0.2
(
0.5;
0.1)
NS
Short
cycles
of
oral
corticosteroids
a
0.1
(
0.2;
0.0)
0.0
(
0.6;
0.6)
0.6
(
1.4;
0.2)
NS
Number
of
days
of
missed
work
and
year
a
0.2
(
4.2;
3.8)
29.3
(
50.1;
8.5)*
108.9
(
170.6;
47.2)*
<.001
Spirometry
FEV
1
,
%
reference
value
0.3
(
1.7;
2.3)
4.2
(
9.4;
1)
1.1
(
5.6;
3.4)
NS

FEV1
postBD
b
0.7
(
1.3;
2.7)
1.2
(
3.8;
6.2)
1.0
(
5.5;
3.5)
NS
Quality
of
life
(SGRQ)
Total
score
5.4
(
9.1;
1.7)
5.7
(
13.2;
1.8)
10.6
(
17.3;
3.9)
NS
Economic
costs
(annual
cost
per
patient
in
Euros)
Direct
costs
334.8
(
492.1;
177.5)
332.5
(
936.3;
271.3)
23
(
592.4;
638.4)
NS
Medication
72.6
(
157;
11.8)
330.3
(91;
569.6)
545.9
(340.9;
786.9)
<.001
Visits
to
primary
care
physician
1.7
(
3.3;
6.7)
51.8
(25.4;
78.2)
47.8
(24.8;
70.8)
<.001
Visits
to
specialist
physician
80.6
(
100.2;
61)
164.8
(
311.9;
17.7)
117.2
(
194.9;
39.5)
NS
Hospitalizations
124.1
(
233.7;
14.5)
462.2
(
896.7;
67.7)
415.7
(
965.4;
134)
NS
Emergency
care
20.0
(
35.3;
4.7)
34.9
(
100.1;
30.3)
4.7
(
54.0;
44.6)
NS
Spirometry
5.1
(
7.5;
2.7)
8.7
(
16.8;
0.6)
6.1
(
10.3;
1.9)
NS
Blood
analyses
1.8
(
1.5;
0.7)
7.3
(0.7;
5.9)
7.9
(0.4;
5.4)
.006
Prick
test,
mean
22.0
(
29.3;
14.7)
11.4
(
22.9;
0.1)
13.6
(
29.8;
2.6)
NS
Chest
radiography
11.0
(
14.3;
7.7)
15.8
(
22.5;
9.1)
16.2
(
24.1;
8.3)
NS
Indirect
costs
43.1
(
135.6;
221.8)
234.4
(
1461.9;
1885.7)
2157.2
(
3919.2;
395.2)
NS
Total
cost
291.7
(
555.2;
28.2)
98.1
(
2025.3;
1829.1)
2134.2
(
4070;
198.4)
NS
Values
expressed
as
differences
from
the
means
for
each
level
of
severity
(95%
confidence
interval),
except
when
indicated
in
the
table
as
number
of
cases
(percentage).
a
Differences
in
the
average
number
of
episodes
per
patient
the
previous
year.
b
(FEV
1
postBD:
%
of
FEV
1
increase
over
the
percentage
of
baseline
FEV
1
basal
after
the
inhalation
of
a
bronchodilator
(salbutamol).
SGRQ:
St.
George’s
Respiratory
Questionnaire.
observed
in
the
Finnish
experience,
where
the
application
of
their
national
program
provided
a
reduction
of
36%
in
total
costs.
5
The
mean
total
cost
in
our
study
was
1464.40
D
,
which
also
does
not
differ
substantially
from
another
study
recently
done
in
a
Spanish
sample
with
627
patients
(ASMACOST
study),
30
which
established
this
amount
at
1533
D
.
The
reduction
in
total
costs
observed
in
the
present
study
came
from
both
the
direct
as
well
as
the
indirect
costs.
Regarding
the
direct
costs,
although
there
was
a
statistically
signif-
icant
increase
in
the
expense
caused
by
the
purchase
of
drugs
and
primary
care
office
visits
in
2004
compared
to
1994,
the
decrease
in
other
direct
costs—particularly
those
related
with
hospitaliza-
tions,
emergency
department
visits
and
specialized
care—resulted
in
a
significant
reduction
in
the
sum
of
the
direct
costs.
Along
the
same
lines,
the
decline
in
the
number
of
days
of
work
missed
pro-
vided
a
significant
and
considerable
reduction,
somewhat
more
than
half,
of
the
indirect
costs.
These
results
are
particularly
rel-
evant
as
some
pharmacoeconomic
studies
usually
present
partial
cost
analyses,
sometimes
elaborated
by
the
health-care
administra-
tions
themselves,
excluding
from
the
evaluation
the
indirect
costs
and
those
related
with
the
frequency
of
health-care
required.
It
is
an
improper
procedure
because
in
this
manner
the
impact
provided
by
the
efficiency
of
the
medication
for
better
controlling
a
disease,
as
happens
in
asthma,
cannot
be
evaluated
in
the
dimension
that
cost
analyses
require.
Other
studies
show
results
that
are
equiva-
lent
to
those
of
this
present
study,
also
finding
an
increase
in
the
costs
for
medication,
but
a
reduction
in
direct
and
total
costs.
5
As
for
the
potential
limitations
of
the
study,
the
quality
of
the
results
could
be
questioned
as
they
are
obtained
from
a
cohort
with
33.3%
of
lost
cases.
Nevertheless,
said
loss
is
within
reason
as
it
is
a
study
carried
out
over
a
prolonged
period
of
time.
In
addition,
this
percentage
is
even
less
than
those
of
other
series
with
similar
designs.
20,31
Therefore,
in
our
opinion,
the
loss
of
cases
in
this
study
does
not
limit
its
validity
or
the
extent
of
its
conclusions.
In
short,
the
present
study
covers
a
lack
of
local
information
about
the
natural
history
of
asthma
in
actual
clinical
practice
situa-
tions.
The
results
demonstrate
a
favorable
evolution
of
the
patients
with
asthma
in
our
setting
in
recent
years.
This
improvement
is
supported
by
a
considerable
reduction
of
the
frequency
of
health-
care
resources
used,
an
important
increase
in
the
quality
of
life
of
the
affected
patients
and,
consequently,
a
notable
reduction
in
total
costs
caused
by
asthma.
Even
though
this
observation
can
probably
be
extrapolated
to
the
rest
of
the
Spanish
asthmatic
population,
it
would
be
recommendable
to
analyze
data
from
studies
with
simi-
lar
designs
and
objectives
from
different
geographical
locations
of
our
country.
Acknowledgements
We
would
like
to
thank
Dr.
Carlos
Badiola
and
Dr.
Alejandro
Pedromingo
for
their
technical
help.
This
study
was
funded
in
part
by
GSK
(Spain).
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