Levodopa–Entacapone–Carbidopa Intrajejunal Infusion in Advanced Parkinson's Disease – Interim Analysis of the ELEGANCE Study
Movement Disorders Clinical Practice,
Journal Year:
2025,
Volume and Issue:
unknown
Published: March 25, 2025
Levodopa-entacapone-carbidopa
intestinal
gel
(LECIG)
was
introduced
in
2018
as
a
device-aided
therapy
for
advanced
Parkinson's
disease
(PD).
The
ELEGANCE
study
(NCT05043103)
is
gathering
real-world
data
on
long-term
efficacy,
safety
and
patient-reported
outcomes
with
LECIG
from
13
European
countries.
This
article
reports
the
planned
interim
analysis.
enrolled
patients
prescribed
part
of
routine
clinical
care.
We
evaluated
at
V1
before
starting
treatment
(in
seven
were
obtained
retrospectively),
thereafter
V2
(3-6
months)
or
V3
(6-12
months).
analysis
includes
167
37
centers.
Three
this
set
(1.8%)
discontinued
study.
Mean
(±SD)
daily
OFF-time
hours
(MDS-UPDRS
IV
item
4.3)
substantially
reduced
by
3.47
±
3.56
h
(baseline:
5.15
3.05;
P
<
0.0001).
Similarly,
MDS-UPDRS
total
scores
4.24
4.08
10.77
3.83);
(P
=
0.0001)
II
3.63
7.76
20.65
8.17;
0.0004).
PDSS-2
sustainably
improved
(reduction
7.38
10.72
[baseline:
25.21
10.62];
0.0001),
PDQ-8
summary
index
score
indicating
an
improvement
quality
life
(QoL)
13.3
19.05
46.34
20.09];
For
all
parameters
improvements
maintained
V3.
Patient-reported
satisfaction
pump
high.
Most
adverse
events
related
to
procedure
device.
Routine
use
up
12
months
provided
sustained
control
motor
symptoms,
well
tolerated
positive
impact
QoL
high
patient
satisfaction.
Language: Английский
The device-aided intrajejunal delivery of levodopa–entacapone–carbidopa intestinal gel the treatment of Parkinson’s disease: overview of efficacy and safety
Expert Review of Medical Devices,
Journal Year:
2025,
Volume and Issue:
unknown
Published: May 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.
Language: Английский