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Phenylketonuria Scientific Review Conference: state of the science and future research needs.
[phenylketonuria]
New
developments
in
the
treatment
and
management
of
phenylketonuria
(
PKU
)
as
well
as
advances
in
molecular
testing
have
emerged
since
the
National
Institutes
of
Health
2000
PKU
Consensus
Statement
was
released
.
An
NIH
State-of-the-
Science
Conference
was
convened
in
2012
to
address
new
findings
,
particularly
the
use
of
the
medication
sapropterin
to
treat
some
individuals
with
PKU
,
and
to
develop
a
research
agenda
.
Prior
to
the
2012
conference
,
five
working
groups
of
experts
and
public
members
met
over
a
1
-
year
period
.
The
working
groups
addressed
the
following
:
long
-term
outcomes
and
management
across
the
lifespan
;
PKU
and
pregnancy
;
diet
control
and
management
;
pharmacologic
interventions
;
and
molecular
testing
,
new
technologies
,
and
epidemiologic
considerations
.
In
a
parallel
and
independent
activity
,
an
Evidence-based
Practice
Center
supported
by
the
Agency
for
Healthcare
Research
and
Quality
conducted
a
systematic
review
of
adjuvant
treatments
for
PKU
;
its
conclusions
were
presented
at
the
conference
.
The
conference
included
the
findings
of
the
working
groups
,
panel
discussions
from
industry
and
international
perspectives
,
and
presentations
on
topics
such
as
emerging
treatments
for
PKU
,
transitioning
to
adult
care
,
and
the
U
.
S
.
Food
and
Drug
Administration
regulatory
perspective
.
Over
85
experts
participated
in
the
conference
through
information
gathering
and
/
or
as
presenters
during
the
conference
,
and
they
reached
several
important
conclusions
.
The
most
serious
neurological
impairments
in
PKU
are
preventable
with
current
dietary
treatment
approaches
.
However
,
a
variety
of
more
subtle
physical
,
cognitive
,
and
behavioral
consequences
of
even
well-controlled
PKU
are
now
recognized
.
The
best
outcomes
in
maternal
PKU
occur
when
blood
phenylalanine
(
Phe
)
concentrations
are
maintained
between
120
and
360
μmol
/
L
before
and
during
pregnancy
.
The
dietary
management
treatment
goal
for
individuals
with
PKU
is
a
blood
Phe
concentration
between
120
and
360
μmol
/
L
.
The
use
of
genotype
information
in
the
newborn
period
may
yield
valuable
insights
about
the
severity
of
the
condition
for
infants
diagnosed
before
maximal
Phe
levels
are
achieved
.
While
emerging
and
established
genotype-phenotype
correlations
may
transform
our
understanding
of
PKU
,
establishing
correlations
with
intellectual
outcomes
is
more
challenging
.
Regarding
the
use
of
sapropterin
in
PKU
,
there
are
significant
gaps
in
predicting
response
to
treatment
;
at
least
half
of
those
with
PKU
will
have
either
minimal
or
no
response
.
A
coordinated
approach
to
PKU
treatment
improves
long
-term
outcomes
for
those
with
PKU
and
facilitates
the
conduct
of
research
to
improve
diagnosis
and
treatment
.
New
drugs
that
are
safe
,
efficacious
,
and
impact
a
larger
proportion
of
individuals
with
PKU
are
needed
.
However
,
it
is
imperative
that
treatment
guidelines
and
the
decision
processes
for
determining
access
to
treatments
be
tied
to
a
solid
evidence
base
with
rigorous
standards
for
robust
and
consistent
data
collection
.
The
process
that
preceded
the
PKU
State-of-the-
Science
Conference
,
the
conference
itself
,
and
the
identification
of
a
research
agenda
have
facilitated
the
development
of
clinical
practice
guidelines
by
professional
organizations
and
serve
as
a
model
for
other
inborn
errors
of
metabolism
.
Diseases
Validation
Diseases presenting
"long-term outcomes"
symptom
acute rheumatic fever
alpha-thalassemia
aromatase deficiency
cholangiocarcinoma
classical phenylketonuria
congenital adrenal hyperplasia
congenital diaphragmatic hernia
cushing syndrome
dystrophic epidermolysis bullosa
esophageal squamous cell carcinoma
hirschsprung disease
homocystinuria without methylmalonic aciduria
kabuki syndrome
lamellar ichthyosis
omenn syndrome
phenylketonuria
proteus syndrome
trochlear dysplasia
von hippel-lindau disease
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