PMID- 12603288
OWN - NLM
STAT- MEDLINE
DCOM- 20030423
LR  - 20191106
IS  - 1351-5101 (Print)
IS  - 1351-5101 (Linking)
VI  - 10
IP  - 2
DP  - 2003 Mar
TI  - The tolerability and efficacy of entacapone over 3 years in patients with 
      Parkinson's disease.
PG  - 137-46
AB  - The long-term safety and efficacy of the catechol-O-methyltransferase (COMT) 
      inhibitor entacapone was investigated in a 3-year open-label extension of the 
      6-month double-blind placebo-controlled Nordic (NOMECOMT) study. After a wash-out 
      following this study, 132 patients with Parkinson's disease (PD) experiencing 
      motor fluctuations treated with levodopa/dopa decarboxylase (DDC) inhibitor 
      received additional therapy with entacapone 200 mg, administered with each dose 
      of levodopa. The most common adverse events (AEs) were insomnia (30%), dizziness 
      (20%), nausea (20%), aggravated parkinsonism (17%) and hallucinations (14%). Only 
      19 (14%) patients discontinued because of AEs. Most dopaminergic AEs occurred 
      shortly after initiation of entacapone, and these could be managed by levodopa 
      down-adjustment. The mean duration of benefit of a single dose of levodopa 
      increased significantly from 2.1 to 2.8 h (P < 0.01) at 3 months and remained 
      prolonged for the whole study. At the end of the study, the mean daily dose of 
      levodopa was significantly decreased from baseline (from 737 to 696 mg; P < 
      0.05). The patients' global assessment indicated that 69% of patients improved 
      when given entacapone and this proportion was maintained until the end of the 
      study (64%). There was a significant worsening of disability upon withdrawal of 
      entacapone. In conclusion, entacapone given in combination with levodopa, has a 
      good long-term safety profile and a sustained beneficial effect in patients with 
      PD with motor fluctuations.
FAU - Larsen, J P
AU  - Larsen JP
AD  - Department of Neurology, Rogaland Central Hospital, Stavanger, Norway. jpl@sir.no
FAU - Worm-Petersen, J
AU  - Worm-Petersen J
FAU - Siden, A
AU  - Siden A
FAU - Gordin, A
AU  - Gordin A
FAU - Reinikainen, K
AU  - Reinikainen K
FAU - Leinonen, M
AU  - Leinonen M
CN  - NOMESAFE Study Group
LA  - eng
PT  - Journal Article
PL  - England
TA  - Eur J Neurol
JT  - European journal of neurology
JID - 9506311
RN  - 0 (Antiparkinson Agents)
RN  - 0 (Catechols)
RN  - 0 (Enzyme Inhibitors)
RN  - 0 (Nitriles)
RN  - 46627O600J (Levodopa)
RN  - 4975G9NM6T (entacapone)
SB  - IM
MH  - Aged
MH  - Antiparkinson Agents/*adverse effects/*therapeutic use
MH  - Catechols/*adverse effects/*therapeutic use
MH  - Drug Therapy, Combination
MH  - Dyskinesia, Drug-Induced/epidemiology
MH  - Enzyme Inhibitors/therapeutic use
MH  - Female
MH  - Humans
MH  - Levodopa/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Nitriles
MH  - Parkinson Disease/*drug therapy
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2003/02/27 04:00
MHDA- 2003/04/24 05:00
CRDT- 2003/02/27 04:00
PHST- 2003/02/27 04:00 [pubmed]
PHST- 2003/04/24 05:00 [medline]
PHST- 2003/02/27 04:00 [entrez]
AID - 559 [pii]
AID - 10.1046/j.1468-1331.2003.00559.x [doi]
PST - ppublish
SO  - Eur J Neurol. 2003 Mar;10(2):137-46. doi: 10.1046/j.1468-1331.2003.00559.x.