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European Adrenal Insufficiency Registry (EU-AIR): a comparative observational study of glucocorticoid replacement therapy.
[congenital adrenal hyperplasia]
Increased
morbidity
and
mortality
associated
with
conventional
glucocorticoid
replacement
therapy
for
primary
adrenal
insufficiency
(
primary
AI
;
estimated
prevalence
93
-
140
/
million
)
,
secondary
AI
(
estimated
prevalence
,
150
-
280
/
million
,
respectively
)
or
congenital
adrenal
hyperplasia
(
estimated
prevalence
,
approximately
65
/
million
)
may
be
due
to
the
inability
of
typical
glucocorticoid
treatment
regimens
to
reproduce
the
normal
circadian
profile
of
plasma
cortisol
.
A
once-daily
modified-release
formulation
of
hydrocortisone
has
been
developed
to
provide
a
plasma
cortisol
profile
that
better
mimics
the
daytime
endogenous
profile
of
cortisol
.
Here
,
we
describe
the
protocol
for
the
European
Adrenal
Insufficiency
Registry
(
EU
-AIR
)
,
an
observational
study
to
assess
the
long
-term
safety
of
modified-release
hydrocortisone
compared
with
conventional
glucocorticoid
replacement
therapies
in
routine
clinical
practice
(
ClinicalTrials
.
gov
identifier
:
NCT
01661387
)
.
Patients
enrolled
in
EU
-AIR
have
primary
or
secondary
AI
and
are
receiving
either
modified-release
or
conventional
glucocorticoid
replacement
therapy
.
The
primary
endpoints
of
EU
-AIR
are
the
incidence
of
intercurrent
illness
,
adrenal
crisis
and
serious
adverse
events
(
SAEs
)
,
as
well
as
the
duration
of
SAEs
and
dose
changes
related
to
SAEs
.
Data
relating
to
morbidity
,
mortality
,
adverse
drug
reactions
,
dosing
and
concomitant
therapies
will
be
collected
.
Patient
diaries
will
record
illness-related
dose
changes
between
visits
.
All
decisions
concerning
medical
care
are
made
by
the
registry
physician
and
patient
.
Enrolment
is
targeted
at
achieving
3600
patient-
years
of
treatment
(
1800
patient-
years
per
group
)
for
the
primary
analysis
,
which
is
focused
on
determining
the
non-inferiority
of
once-daily
modified-release
replacement
therapy
compared
with
conventional
glucocorticoid
therapy
.
Recruitment
began
in
August
2012
and
,
as
of
March
2014
,
801
patients
have
been
enrolled
.
Fifteen
centres
are
participating
in
Germany
,
the
UK
and
Sweden
,
with
recruitment
soon
to
be
initiated
in
the
Netherlands
.
EU
-AIR
will
provide
a
unique
opportunity
not
only
to
collect
long
-term
safety
data
on
a
modified-release
preparation
of
glucocorticoid
but
also
to
evaluate
baseline
data
on
conventional
glucocorticoid
replacement
.
Such
data
should
help
to
improve
the
treatment
of
AI
.
Diseases
Validation
Diseases presenting
"long-term safety data on a modified-release preparation"
symptom
congenital adrenal hyperplasia
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