Expert Review of Medical Devices,
Год журнала:
2025,
Номер
unknown
Опубликована: Май 7, 2025
Device-aided
therapies
(DATs)
have
been
developed
to
provide
continuous
drug
delivery
(CDD)
people
with
advanced
Parkinson's
disease
(PD)
whose
symptoms
can
no
longer
be
effectively
managed
oral
or
transdermal
therapy.
Intrajejunal
infusion
of
levodopa
-
carbidopa
intestinal
gel
(LCIG),
delivered
via
the
CADD
Legacy
1400
pump,
is
an
established
CDD
option,
while
entacapone
(LECIG),
Crono
LECIG
a
more
recent
addition
range
DAT
options
in
Europe.
This
article
explores
rationale
for
development
infusion,
role
formulation,
and
attributes
specifications
pump
device.
Clinical
real-world
data
reporting
its
efficacy,
safety
tolerability
PD
patients
from
European
centers
are
reviewed,
focus
on
practical
benefits
that
smaller,
lighter
quieter
device
who
wish
start
treatment
intrajejunal
infusion.
offers
another
valuable
option
consider
suitable
providing
both
good
long-term
clinical
favorable
experience
patients.
Journal of Geriatric Psychiatry and Neurology,
Год журнала:
2025,
Номер
unknown
Опубликована: Апрель 20, 2025
Introduction
Recent
research
in
Parkinson’s
disease
(PD)
has
highlighted
the
potential
therapies
of
continuous
subcutaneous
infusions
(CSCI)
levodopa/carbidopa
(ND0612)
and
foslevodopa/foscarbidopa
(ABBV-951).
This
systematic
review
aims
to
explore
their
effectiveness
safety
for
PD.
Methods
Guided
by
PRISMA
statement,
we
systematically
searched
3
electronic
databases:
MEDLINE,
Embase,
Cochrane
Central.
We
combined
quantitative
qualitative
data
synthesis
descriptive
analysis.
Quality
assessment
risk
bias
were
evaluated
ROBINS-1
Rob-2
criteria.
Results
included
6
records
with
a
total
698
patients.
CSCI
reduced
motor
symptoms
PD
patients
levodopa-related
fluctuations
clinical
improvements.
Infusions-site
reactions
main
adverse
event
recorded.
Conclusions
ND0612
ABBV-951
are
promising
options
enhancing
control
quality
life
However,
further
is
needed
assess
long-term
efficacy,
safety,
comparisons
oral
levodopa
device-aided
treatments.
Clinical Parkinsonism & Related Disorders,
Год журнала:
2025,
Номер
12, С. 100330 - 100330
Опубликована: Янв. 1, 2025
Parkinson's
disease
(PD)
non-motor
symptom
burden,
including
nocturia
and
sleep
disturbances,
worsens
with
progression.
Continuous
dopaminergic
drug
delivery
nocturnal
infusion
in
PD
demonstrated
improvements
nocturia.
Foslevodopa/foscarbidopa
(LDp/CDp)
provides
24-hour
continuous
of
levodopa/carbidopa
(LD/CD)
prodrugs
via
subcutaneous
(CSCI).
Least-squares
mean
changes
(measured
Disease
Sleep
Scale-2
item
8)
patients
from
a
randomized
12-week
phase
3
trial
LDp/CDp
CSCI
versus
oral
LD/CD
(NCT04380142)
52-week
open-label
(NCT03781167)
were
analyzed
post
hoc
mixed-effects
regression
analysis
covariance.
Correlation
coefficients
at
baseline
(BL)
change
BL
to
week
12
or
52
(Δ
BL-wk
Δ
52)
for
quality
life
(QoL,
measured
as
Questionnaire
[PDQ-39]
Summary
Index
score)
calculated
Spearman's
test.
This
exploratory
significant
sustained
improvement
symptoms
treatment
both
the
(to
12;
n
=
44;
nominal
p
≤
0.01)
weeks
6,
13,
26,
52;
176,
149,
107,
75,
respectively;
0.001
all)
trials.
Nocturia
was
significantly
greater
LDp/CDp-
oral-treated
(n
59;
0.05).
A
positive
correlation
between
QoL
shown
(nominal
0.05
both),
while
results
showed
no
correlations.
LDp/CDp-treated
improved
therapy,
than
patient-reported
may
correlate
QoL.
Movement Disorders Clinical Practice,
Год журнала:
2025,
Номер
unknown
Опубликована: Май 6, 2025
Abstract
Background
Device‐aided
therapies
(DAT)
offer
alternatives
to
oral
or
transdermal
dopaminergic
treatments
in
advanced
Parkinson's
disease
(PD),
where
they
can
reduce
motor
fluctuations
and
dyskinesia
improve
health‐related
quality
of
life
(HRQoL).
The
5‐2‐1
criteria
be
seen
as
a
rough
indicator
when
DAT
might
considered,
that
is,
patient
has
daily
≥2
hours
off
and/or
≥1
hour
troublesome
despite
≥5
levodopa
intakes.
Objectives
objective
was
analyze
differences
HRQoL
clinical
outcomes
patients
fulfilling
not
the
criteria.
Methods
Patients
from
three
different
regions
Sweden,
registered
National
Disease
Patient
Registry
(PARKreg),
with
registrations
hours,
Questionnaire‐8
(PDQ‐8)
score
were
included.
generic
QoL
questionnaire
EQ‐5D
also
evaluated.
Data
PARKreg
complemented
data
medical
record
review.
Results
In
total,
365
(36%)
1085
sufficient
information
met
meeting
had
significantly
lower
HRQoL,
measured
by
PDQ‐8
EQ‐5D,
compared
those
Each
additional
spent
associated
time
state
strongest
impact.
Conclusions
identified
high
burden
poor
QoL,
combination
dyskinesia.
This
delineates
group
for
whom
further
investigation
candidacy
other
optimizations
may
indicated.
Expert Review of Medical Devices,
Год журнала:
2025,
Номер
unknown
Опубликована: Май 7, 2025
Device-aided
therapies
(DATs)
have
been
developed
to
provide
continuous
drug
delivery
(CDD)
people
with
advanced
Parkinson's
disease
(PD)
whose
symptoms
can
no
longer
be
effectively
managed
oral
or
transdermal
therapy.
Intrajejunal
infusion
of
levodopa
-
carbidopa
intestinal
gel
(LCIG),
delivered
via
the
CADD
Legacy
1400
pump,
is
an
established
CDD
option,
while
entacapone
(LECIG),
Crono
LECIG
a
more
recent
addition
range
DAT
options
in
Europe.
This
article
explores
rationale
for
development
infusion,
role
formulation,
and
attributes
specifications
pump
device.
Clinical
real-world
data
reporting
its
efficacy,
safety
tolerability
PD
patients
from
European
centers
are
reviewed,
focus
on
practical
benefits
that
smaller,
lighter
quieter
device
who
wish
start
treatment
intrajejunal
infusion.
offers
another
valuable
option
consider
suitable
providing
both
good
long-term
clinical
favorable
experience
patients.
