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Direct switch from levodopa/benserazide or levodopa/carbidopa to levodopa/carbidopa/entacapone in Parkinson's disease patients with wearing-off: efficacy, safety and feasibility--an open-label, 6-week study.

Abstract
The study objective was to assess the efficacy, safety and feasibility of switching from levodopa/benserazide (LB) or levodopa/carbidopa (LC) to levodopa/carbidopa/entacapone (LCE) in Parkinson's disease (PD) patients with wearing-off. This was a multicenter, open-label, 6-week study; the primary outcome was success rate based on the patient-assessed Clinical Global Impression of Change (P-CGI-C). Secondary outcomes included investigator-assessed CGI-C (I-CGI-C), change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS), motor/non-motor wearing-off symptoms and quality of life-visual analog scale (QoL-VAS). After switching to LCE, 77% of patients reported an 'improvement' (p < 0.0001 vs. patients reporting 'no change or worsening'). Significant improvements were seen in I-CGI-C, UPDRS and QoL-VAS, regardless of prior therapy. Oral levodopa dosing was increased in 28% of patients; the primary outcome remained significant when these patients were excluded. The data suggest that switching from LB/LC to LCE provided a significant benefit in PD patients with wearing-off.
AuthorsKarla Eggert, Orjan Skogar, Khaled Amar, Liisa Luotonen, Mikko Kuoppamäki, Mika Leinonen, Helena Nissinen, Wolfgang Oertel
JournalJournal of neural transmission (Vienna, Austria : 1996) (J Neural Transm (Vienna)) Vol. 117 Issue 3 Pg. 333-42 (Mar 2010) ISSN: 1435-1463 [Electronic] Austria
PMID20013007 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • Antiparkinson Agents
  • Catechols
  • Nitriles
  • Levodopa
  • entacapone
  • Benserazide
  • Carbidopa
Topics
  • Aged
  • Antiparkinson Agents (administration & dosage, adverse effects, therapeutic use)
  • Benserazide (administration & dosage, adverse effects, therapeutic use)
  • Carbidopa (administration & dosage, adverse effects, therapeutic use)
  • Catechols (administration & dosage, adverse effects, therapeutic use)
  • Drug-Related Side Effects and Adverse Reactions
  • Dyskinesias (drug therapy)
  • Feasibility Studies
  • Female
  • Humans
  • Levodopa (administration & dosage, adverse effects, therapeutic use)
  • Male
  • Nitriles (administration & dosage, adverse effects, therapeutic use)
  • Parkinson Disease (drug therapy)
  • Severity of Illness Index
  • Surveys and Questionnaires
  • Treatment Outcome

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