PMID- 28374689
OWN - NLM
STAT- MEDLINE
DCOM- 20170810
LR  - 20181202
IS  - 1997-7298 (Print)
IS  - 1997-7298 (Linking)
VI  - 117
IP  - 2
DP  - 2017
TI  - [Levodopa-carbidopa intestinal gel in the treatment of patients with Parkinson 
      disease: results of a 12-month open study].
PG  - 22-31
LID - 10.17116/jnevro20171172122-31 [doi]
AB  - AIM: To evaluate the long-term safety and efficacy of intrajejunal 
      levodopa-carbidopa intestinal gel (LCIG) infusion in the treatment of patients 
      with severe stages of Parkinson disease (PD) who did not respond adequately to 
      treatment with oral drugs. MATERIAL AND METHODS: A large-scale international 
      prospective open-label 54-week study of LCIG in patients with PD with severe 
      motor fluctuations was carried out. A total of 48 patients were enrolled in 
      Russia, 46 patients (95.8%) had PEG-J inserted, and 43 of them completed the 
      study. The safety, including adverse events (AEs), infusion system and pump 
      failures analysis, number of patients completely terminated the study, and 
      efficacy (duration of "off" periods, "on" periods with or without troublesome 
      dyskinesias, UPDRS scores, Clinical Global Impression, Quality of Life (PDQ-39, 
      EQ-5D small i, Cyrillic EQ-VAS) dynamics, an analysis of patient's diaries) were assessed 
      throughout the whole study. RESULTS: The majority of AEs were mild or moderate 
      with most AEs connected with infusion system application (28.3% patients) 
      including procedure pain. Serious AEs were registered in 8 patients (16.7%). 3 
      patients (6.3%) discontinued their participation in the study due to AEs. Mean 
      duration of "off" periods by the end of the study decreased by 5.35+/-2.59 hours 
      (p<0.001), duration of "on" periods without troublesome dyskinesia increased by 
      5.74+/-3.91 hours (p<0.001), reduction of "on" periods duration with troublesome 
      dyskinesia became statistically significant by week 36 (p=0.020). The 
      statistically significant improvement of UPDRS (generally and in respect to 
      sub-scales), Clinical Global Impression, and Quality of Life scores was observed 
      throughout the study. Levodopa dose remained stable throughout the 54 treatment 
      weeks. Forty-three patients (93.5%) received LCIG monotherapy throughout the 
      whole study. CONCLUSION: LCIG intrajejunal infusion during 54 weeks showed the 
      favorable safety profile, high tolerability, and efficacy in PD motor symptoms 
      correction.
FAU - Skoromets, A A
AU  - Skoromets AA
AD  - Pavlov First St.-Petersburg State Medical University, St.-Petersburg.
FAU - Odinak, M M
AU  - Odinak MM
AD  - Kirov Military Medical Academy, St.-Petersburg.
FAU - Yakupov, E Z
AU  - Yakupov EZ
AD  - Research Medical Complex "Your Health", Kazan.
FAU - Litvinenko, I V
AU  - Litvinenko IV
AD  - Kirov Military Medical Academy, St.-Petersburg.
FAU - Zalyalova, Z A
AU  - Zalyalova ZA
AD  - Kazan State University.
FAU - Timofeeva, A A
AU  - Timofeeva AA
AD  - Pavlov First St.-Petersburg State Medical University, St.-Petersburg.
FAU - Kirtaev, S Yu
AU  - Kirtaev SY
AD  - Kirov Military Medical Academy, St.-Petersburg.
FAU - Bogdanov, R R
AU  - Bogdanov RR
AD  - Kazan.
FAU - Agafina, A S
AU  - Agafina AS
AD  - Vladimirsky Moscow Regional Clinical and Research Institute, Moscow.
FAU - Chatamra, K
AU  - Chatamra K
AD  - St.-Petersburg City Hospital N 40, St.-Petersburg.
FAU - Robieson, W
AU  - Robieson W
AD  - St.-Petersburg City Hospital N 40, St.-Petersburg.
FAU - Benesh, J
AU  - Benesh J
AD  - St.-Petersburg City Hospital N 40, St.-Petersburg.
FAU - Latypova, G R
AU  - Latypova GR
AD  - AbbVie, Repablic Clinical Diagnostic Center Extrapyramidal Pathologies and 
      Botulinotherapiya, Kazan.
FAU - Ershova, M V
AU  - Ershova MV
AD  - Research Center of Neurology, Moscow, Russia.
FAU - Illarioshkin, S N
AU  - Illarioshkin SN
AD  - Research Center of Neurology, Moscow, Russia.
LA  - rus
PT  - Journal Article
TT  - Levodopa-karbidopa intestinal'nyi gel' v terapii bol'nykh s razvernutymi 
      stadiyami bolezni Parkinsona: rezul'taty 12-mesyachnogo otkrytogo issledovaniya.
PL  - Russia (Federation)
TA  - Zh Nevrol Psikhiatr Im S S Korsakova
JT  - Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova
JID - 9712194
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
MH  - Aged
MH  - Antiparkinson Agents/administration & dosage/*adverse effects/therapeutic use
MH  - Carbidopa/administration & dosage/*adverse effects/therapeutic use
MH  - Drug Combinations
MH  - Dyskinesia, Drug-Induced/etiology
MH  - Female
MH  - Gels
MH  - Humans
MH  - Infusion Pumps
MH  - Jejunum
MH  - Levodopa/administration & dosage/*adverse effects/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Pain/etiology
MH  - Parkinson Disease/*drug therapy
MH  - Prospective Studies
MH  - Quality of Life
MH  - Russia
EDAT- 2017/04/05 06:00
MHDA- 2017/08/11 06:00
CRDT- 2017/04/05 06:00
PHST- 2017/04/05 06:00 [entrez]
PHST- 2017/04/05 06:00 [pubmed]
PHST- 2017/08/11 06:00 [medline]
AID - 10.17116/jnevro20171172122-31 [doi]
PST - ppublish
SO  - Zh Nevrol Psikhiatr Im S S Korsakova. 2017;117(2):22-31. doi: 
      10.17116/jnevro20171172122-31.