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

J Neural Transm (Vienna). 2010 Mar;117(3):333-42. doi: 10.1007/s00702-009-0344-4. Epub 2009 Dec 15.

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.

Publication types

  • Clinical Trial, Phase IV
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antiparkinson Agents / administration & dosage
  • Antiparkinson Agents / adverse effects
  • Antiparkinson Agents / therapeutic use*
  • Benserazide / administration & dosage
  • Benserazide / adverse effects
  • Benserazide / therapeutic use*
  • Carbidopa / administration & dosage
  • Carbidopa / adverse effects
  • Carbidopa / therapeutic use*
  • Catechols / administration & dosage
  • Catechols / adverse effects
  • Catechols / therapeutic use*
  • Drug-Related Side Effects and Adverse Reactions
  • Dyskinesias / drug therapy
  • Feasibility Studies
  • Female
  • Humans
  • Levodopa / administration & dosage
  • Levodopa / adverse effects
  • Levodopa / therapeutic use*
  • Male
  • Nitriles / administration & dosage
  • Nitriles / adverse effects
  • Nitriles / therapeutic use*
  • Parkinson Disease / drug therapy*
  • Severity of Illness Index
  • Surveys and Questionnaires
  • Treatment Outcome

Substances

  • Antiparkinson Agents
  • Catechols
  • Nitriles
  • Levodopa
  • entacapone
  • Benserazide
  • Carbidopa