PMID- 25545465
OWN - NLM
STAT- MEDLINE
DCOM- 20151221
LR  - 20220408
IS  - 1531-8257 (Electronic)
IS  - 0885-3185 (Print)
IS  - 0885-3185 (Linking)
VI  - 30
IP  - 4
DP  - 2015 Apr
TI  - Levodopa-carbidopa intestinal gel in advanced Parkinson's disease: final 
      12-month, open-label results.
PG  - 500-9
LID - 10.1002/mds.26123 [doi]
AB  - Motor complications in Parkinson's disease (PD) are associated with long-term 
      oral levodopa treatment and linked to pulsatile dopaminergic stimulation. 
      L-dopa-carbidopa intestinal gel (LCIG) is delivered continuously by percutaneous 
      endoscopic gastrojejunostomy tube (PEG-J), which reduces L-dopa-plasma-level 
      fluctuations and can translate to reduced motor complications. We present final 
      results of the largest international, prospective, 54-week, open-label LCIG 
      study. PD patients with severe motor fluctuations (>3 h/day "off" time) despite 
      optimized therapy received LCIG monotherapy. Additional PD medications were 
      allowed >28 days post-LCIG initiation. Safety was the primary endpoint measured 
      through adverse events (AEs), device complications, and number of completers. 
      Secondary endpoints included diary-assessed off time, "on" time with/without 
      troublesome dyskinesia, UPDRS, and health-related quality-of-life (HRQoL) 
      outcomes. Of 354 enrolled patients, 324 (91.5%) received PEG-J and 272 (76.8%) 
      completed the study. Most AEs were mild/moderate and transient; complication of 
      device insertion (34.9%) was the most common. Twenty-seven (7.6%) patients 
      withdrew because of AEs. Serious AEs occurred in 105 (32.4%), most commonly 
      complication of device insertion (6.5%). Mean daily off time decreased by 4.4 
      h/65.6% (P < 0.001). On time without troublesome dyskinesia increased by 4.8 
      h/62.9% (P < 0.001); on time with troublesome dyskinesia decreased by 0.4 h/22.5% 
      (P = 0.023). Improvements persisted from week 4 through study completion. UPDRS 
      and HRQoL outcomes were also improved throughout. In the advanced PD population, 
      LCIG's safety profile consisted primarily of AEs associated with the 
      device/procedure, l-dopa/carbidopa, and advanced PD. LCIG was generally well 
      tolerated and demonstrated clinically significant improvements in motor function, 
      daily activities, and HRQoL sustained over 54 weeks.
CI  - (c) 2014 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on 
      behalf of International Parkinson and Movement Disorder Society.
FAU - Fernandez, Hubert H
AU  - Fernandez HH
AD  - Center for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio, USA.
FAU - Standaert, David G
AU  - Standaert DG
FAU - Hauser, Robert A
AU  - Hauser RA
FAU - Lang, Anthony E
AU  - Lang AE
FAU - Fung, Victor S C
AU  - Fung VS
FAU - Klostermann, Fabian
AU  - Klostermann F
FAU - Lew, Mark F
AU  - Lew MF
FAU - Odin, Per
AU  - Odin P
FAU - Steiger, Malcolm
AU  - Steiger M
FAU - Yakupov, Eduard Z
AU  - Yakupov EZ
FAU - Chouinard, Sylvain
AU  - Chouinard S
FAU - Suchowersky, Oksana
AU  - Suchowersky O
FAU - Dubow, Jordan
AU  - Dubow J
FAU - Hall, Coleen M
AU  - Hall CM
FAU - Chatamra, Krai
AU  - Chatamra K
FAU - Robieson, Weining Z
AU  - Robieson WZ
FAU - Benesh, Janet A
AU  - Benesh JA
FAU - Espay, Alberto J
AU  - Espay AJ
LA  - eng
SI  - ClinicalTrials.gov/NCT00335153
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20141224
PL  - United States
TA  - Mov Disord
JT  - Movement disorders : official journal of the Movement Disorder Society
JID - 8610688
RN  - 0 (Antiparkinson Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Gels)
RN  - 0 (carbidopa, levodopa drug combination)
RN  - 46627O600J (Levodopa)
RN  - MNX7R8C5VO (Carbidopa)
SB  - IM
CIN - Mov Disord. 2015 Apr;30(4):443-5. PMID: 25757898
CIN - Mov Disord. 2015 Sep;30(10):1435-6. PMID: 26179940
CIN - Mov Disord. 2015 Sep;30(10):1434-5. PMID: 26184074
MH  - Adult
MH  - Aged
MH  - Antiparkinson Agents/*therapeutic use
MH  - Carbidopa/*therapeutic use
MH  - Drug Combinations
MH  - Female
MH  - *Gels/therapeutic use
MH  - Humans
MH  - Intestines/drug effects/*physiology
MH  - Levodopa/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Parkinson Disease/*drug therapy
MH  - Prospective Studies
MH  - Severity of Illness Index
MH  - Treatment Outcome
PMC - PMC4674978
OTO - NOTNLM
OT  - dyskinesia
OT  - infusion
OT  - levodopa-carbidopa intestinal gel
OT  - percutaneous endoscopic gastrojejunostomy
OT  - "off" time
EDAT- 2014/12/30 06:00
MHDA- 2015/12/22 06:00
PMCR- 2015/12/10
CRDT- 2014/12/30 06:00
PHST- 2014/08/28 00:00 [received]
PHST- 2014/11/07 00:00 [revised]
PHST- 2014/11/18 00:00 [accepted]
PHST- 2014/12/30 06:00 [entrez]
PHST- 2014/12/30 06:00 [pubmed]
PHST- 2015/12/22 06:00 [medline]
PHST- 2015/12/10 00:00 [pmc-release]
AID - 10.1002/mds.26123 [doi]
PST - ppublish
SO  - Mov Disord. 2015 Apr;30(4):500-9. doi: 10.1002/mds.26123. Epub 2014 Dec 24.