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Abiraterone acetate to lower androgens in women with classic 21-hydroxylase deficiency.
[congenital adrenal hyperplasia]
Chronic
supraphysiological
glucocorticoid
therapy
controls
the
androgen
excess
of
21
-
hydroxylase
deficiency
(
21
OHD
)
but
contributes
to
the
high
prevalence
of
obesity
,
glucose
intolerance
,
and
reduced
bone
mass
in
these
patients
.
Abiraterone
acetate
(
AA
)
is
a
prodrug
for
abiraterone
,
a
potent
CYP
17
A
1
inhibitor
used
to
suppress
androgens
in
the
treatment
of
prostate
cancer
.
The
objective
of
the
study
was
to
test
the
hypothesis
that
AA
added
to
physiological
hydrocortisone
and
9
α-fludrocortisone
acetate
corrects
androgen
excess
in
women
with
21
OHD
without
causing
hypertension
or
hypokalemia
.
This
was
a
phase
1
dose-escalation
study
.
The
study
was
conducted
at
university
clinical
research
centers
.
We
screened
14
women
with
classic
21
OHD
taking
hydrocortisone
12
.
5
-
20
mg
/
d
to
enroll
six
participants
with
serum
androstenedione
greater
than
345
ng
/
dL
(
>
12
nmol
/
L
)
.
AA
was
administered
for
6
days
at
100
or
250
mg
every
morning
with
20
mg
/
d
hydrocortisone
and
9
α-fludrocortisone
acetate
.
The
primary
endpoint
was
normalization
of
mean
predose
androstenedione
on
days
6
and
7
(
<
230
ng
/
dL
[
<
8
nmol
/
L
)
]
in
greater
than
80
%
of
participants
.
Secondary
end
points
included
serum
17
-
hydroxyprogesterone
and
testosterone
(
T
)
,
electrolytes
,
plasma
renin
activity
,
and
urine
androsterone
and
etiocholanolone
glucuronides
.
With
100
mg
/
d
AA
,
mean
predose
androstenedione
fell
from
764
to
254
ng
/
dL
(
26
.
7
-
8
.
9
nmol
/
L
)
.
At
250
mg
/
d
AA
,
mean
androstenedione
normalized
in
five
participants
(
83
%
)
and
decreased
from
664
to
126
ng
/
dL
(
23
.
2
-
4
.
4
nmol
/
L
)
,
meeting
the
primary
end
point
.
Mean
androstenedione
declined
further
during
day
6
to
66
and
38
ng
/
dL
(
2
.
3
and
1
.
3
nmol
/
L
)
at
100
and
250
mg
/
d
,
respectively
.
Serum
T
and
urinary
metabolites
declined
similarly
.
Abiraterone
exposure
was
strongly
negatively
correlated
with
mean
androstenedione
.
Hypertension
and
hypokalemia
were
not
observed
.
AA
100
-
250
mg
/
d
added
to
replacement
hydrocortisone
normalized
several
measures
of
androgen
excess
in
women
with
classic
21
OHD
and
elevated
serum
androstenedione
.
Diseases
Validation
Diseases presenting
"hypertension and hypokalemia"
symptom
congenital adrenal hyperplasia
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