Movement Disorders - Original Article

Journal of Neural Transmission

, Volume 117, Issue 3, pp 333-342

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

  • Karla EggertAffiliated withDepartment of Neurology, Philipps-University Marburg Email author 
  • , Örjan SkogarAffiliated withLänssjukhuset Ryhov
  • , Khaled AmarAffiliated withRoyal Bournemouth Hospital
  • , Liisa LuotonenAffiliated withOrion Pharma
  • , Mikko KuoppamäkiAffiliated withOrion PharmaDepartment of Neurology, University of Turku
  • , Mika LeinonenAffiliated with4Pharma
  • , Helena NissinenAffiliated withOrion Pharma
  • , Wolfgang OertelAffiliated withDepartment of Neurology, Philipps-University Marburg

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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.

Keywords

Levodopa Entacapone Carbidopa Benserazide Wearing-off 9-item Wearing-off Questionnaire