PMID- 11509081
OWN - NLM
STAT- MEDLINE
DCOM- 20010920
LR  - 20191105
IS  - 1351-5101 (Print)
IS  - 1351-5101 (Linking)
VI  - 8
IP  - 1
DP  - 2001 Jan
TI  - Twelve-month safety of entacapone in patients with Parkinson's disease.
PG  - 53-60
AB  - The safety of entacapone combined with levodopa and a dopadecarboxylase (DDC) 
      inhibitor was tested in a 12-month double-blind study of 326 patients with 
      idiopathic Parkinson's disease (PD). The study population represented 'typical' 
      PD outpatients, including patients with varying disease severity and with various 
      concomitant medications. Two-thirds of the patients were randomized to receive 
      200 mg of entacapone with each of 2--10 daily levodopa doses, and one-third to 
      receive placebo. All entacapone patients were included in the safety evaluation 
      of adverse events (AEs), vital signs, ECG, and laboratory parameters. Entacapone 
      was well tolerated with a discontinuation rate due to AEs of 14% compared with 
      11% with placebo (NS). As expected, due to dopaminergic enhancement, dyskinesia 
      was more frequent as an AE with entacapone than with placebo. Dryness of mouth, 
      urine discoloration and diarrhoea were more frequent non-dopaminergic AEs with 
      entacapone than with placebo. Entacapone had no adverse effects on hepatic enzyme 
      activity, ECG or haemodynamic parameters, and there was no evidence of any 
      toxicity. As an indication of levodopa enhancement with entacapone, patients 
      taking 5--10 doses of levodopa, most likely representing predominantly 
      fluctuating patients, showed a significant decrease in their mean daily levodopa 
      dose of 94 mg in the entacapone group compared with a decrease of 39 mg in the 
      placebo group (P < 0.01). The interval between the first two morning doses of 
      levodopa increased by 17% with entacapone, whereas with placebo no extension was 
      observed (P < 0.05). Despite levodopa dose reduction, efficacy of entacapone was 
      maintained. As further evidence of efficacy, Parkinsonian symptoms markedly 
      worsened in all patients after withdrawal of entacapone. We conclude that 
      entacapone is safe in optimizing levodopa in long-term treatment of idiopathic 
      Parkinson's disease. Monitoring of liver or other safety parameters during 
      entacapone treatment is not required.
FAU - Myllyla, V V
AU  - Myllyla VV
AD  - Department of Neurology, University of Oulu, Finland. vilho.myllyla@oulu.fi
FAU - Kultalahti, E R
AU  - Kultalahti ER
FAU - Haapaniemi, H
AU  - Haapaniemi H
FAU - Leinonen, M
AU  - Leinonen M
CN  - FILOMEN Study Group
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - Eur J Neurol
JT  - European journal of neurology
JID - 9506311
RN  - 0 (Antiparkinson Agents)
RN  - 0 (Catechols)
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  - Disability Evaluation
MH  - Double-Blind Method
MH  - Drug Synergism
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Levodopa/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Nitriles
MH  - Parkinson Disease/*drug therapy/physiopathology
MH  - Safety
MH  - Time Factors
EDAT- 2001/08/18 10:00
MHDA- 2001/09/21 10:01
CRDT- 2001/08/18 10:00
PHST- 2001/08/18 10:00 [pubmed]
PHST- 2001/09/21 10:01 [medline]
PHST- 2001/08/18 10:00 [entrez]
AID - ene168 [pii]
AID - 10.1046/j.1468-1331.2001.00168.x [doi]
PST - ppublish
SO  - Eur J Neurol. 2001 Jan;8(1):53-60. doi: 10.1046/j.1468-1331.2001.00168.x.