PMID- 14499313
OWN - NLM
STAT- MEDLINE
DCOM- 20040105
LR  - 20131125
IS  - 0278-5846 (Print)
IS  - 0278-5846 (Linking)
VI  - 27
IP  - 6
DP  - 2003 Sep
TI  - Efficacy and safety of levodopa with entacapone in Parkinson's disease patients 
      suboptimally controlled with levodopa alone, in daily clinical practice: an 
      international, multicentre, open-label study.
PG  - 963-71
AB  - The combination of entacapone with levodopa is effective in the treatment of 
      Parkinson's disease (PD), providing significant improvements in 'on' time and 
      Unified Parkinson's Disease Rating Scale (UPDRS) motor and ADL scores in 
      controlled clinical trials. This multicentre, open-label study was designed to 
      further evaluate the effectiveness of levodopa combined with entacapone 200 mg in 
      routine clinical practice. Patients experiencing end-of-dose wearing-off were 
      treated for 8 weeks (treatment phase), with an optional extension phase up to 20 
      weeks. The primary efficacy parameter was the Investigators' Global Assessment of 
      Change; secondary efficacy parameters included UPDRS, 'off' time (from patient 
      diaries), Patients' Global Assessment of Change, quality of life (QoL), SF-36 
      Health Assessment Questionnaire and Parkinson's Disease Questionnaire 39 
      (PDQ-39). Of the 479 patients who entered this study, 427 (89.1%) completed the 
      treatment phase and 374 (78.1%) continued into the extension phase. Based on the 
      Investigators' Assessment of Change, 380 (79.7%) patients showed an improvement 
      with entacapone during the treatment phase. This improvement was maintained into 
      the extension phase, and at Week 20, 301 (82.2%) patients continued to show an 
      improvement. A positive treatment effect with entacapone was also seen with all 
      secondary efficacy parameters, including QoL. Mean change in the total PDQ-39 
      scores showed improvements from baseline of -4.0 score points to the end of the 
      treatment phase (n=182) and -3.1 score points at the end of the extension phase 
      (n=152). Entacapone in combination with levodopa was generally well tolerated: 40 
      patients (8.4%) discontinued treatment due to adverse events (AEs) by the end of 
      the extension phase. This study in a daily clinical practice setting confirmed 
      the efficacy of coadministering entacapone with levodopa shown in controlled 
      clinical trials and suggests that the combination is useful in improving the 
      disability and QoL in patients with PD.
FAU - Gershanik, Oscar
AU  - Gershanik O
AD  - Hospital Frances La Rioja 951, Buenos Aires, Argentina.
FAU - Emre, Murat
AU  - Emre M
FAU - Bernhard, Gudrun
AU  - Bernhard G
FAU - Sauer, Dirk
AU  - Sauer D
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Prog Neuropsychopharmacol Biol Psychiatry
JT  - Progress in neuro-psychopharmacology & biological psychiatry
JID - 8211617
RN  - 0 (Catechols)
RN  - 0 (Nitriles)
RN  - 46627O600J (Levodopa)
RN  - 4975G9NM6T (entacapone)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Catechols/*administration & dosage/*adverse effects
MH  - Confidence Intervals
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Internationality
MH  - Levodopa/*administration & dosage/*adverse effects
MH  - Male
MH  - Middle Aged
MH  - Nitriles
MH  - Parkinson Disease/*drug therapy/physiopathology/psychology
MH  - Prospective Studies
EDAT- 2003/09/23 05:00
MHDA- 2004/01/06 05:00
CRDT- 2003/09/23 05:00
PHST- 2003/09/23 05:00 [pubmed]
PHST- 2004/01/06 05:00 [medline]
PHST- 2003/09/23 05:00 [entrez]
AID - S0278-5846(03)00156-8 [pii]
AID - 10.1016/S0278-5846(03)00156-8 [doi]
PST - ppublish
SO  - Prog Neuropsychopharmacol Biol Psychiatry. 2003 Sep;27(6):963-71. doi: 
      10.1016/S0278-5846(03)00156-8.