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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.
J Neural Transm (Vienna). 2010 Mar; 117(3):333-42.JN

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.

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Authors+Show Affiliations

Eggert K
Department of Neurology, Philipps-University Marburg, Marburg, Germany. eggert@med.uni-marburg.de
Skogar O
No affiliation info available
Amar K
No affiliation info available
Luotonen L
No affiliation info available
Kuoppamäki M
No affiliation info available
Leinonen M
No affiliation info available
Nissinen H
No affiliation info available
Oertel W
No affiliation info available

MeSH

AgedAntiparkinson AgentsBenserazideCarbidopaCatecholsDrug-Related Side Effects and Adverse ReactionsDyskinesiasFeasibility StudiesFemaleHumansLevodopaMaleNitrilesParkinson DiseaseSeverity of Illness IndexSurveys and QuestionnairesTreatment Outcome

Pub Type(s)

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

Language

eng

PubMed ID

20013007

Citation

Eggert, Karla, et al. "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." Journal of Neural Transmission (Vienna, Austria : 1996), vol. 117, no. 3, 2010, pp. 333-42.
Eggert K, Skogar O, Amar K, et al. 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;117(3):333-42.
Eggert, K., Skogar, O., Amar, K., Luotonen, L., Kuoppamäki, M., Leinonen, M., Nissinen, H., & Oertel, W. (2010). 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. Journal of Neural Transmission (Vienna, Austria : 1996), 117(3), 333-42. https://doi.org/10.1007/s00702-009-0344-4
Eggert K, et al. 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;117(3):333-42. PubMed PMID: 20013007.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Eggert,Karla, AU - Skogar,Orjan, AU - Amar,Khaled, AU - Luotonen,Liisa, AU - Kuoppamäki,Mikko, AU - Leinonen,Mika, AU - Nissinen,Helena, AU - Oertel,Wolfgang, Y1 - 2009/12/15/ PY - 2009/05/11/received PY - 2009/11/13/accepted PY - 2009/12/17/entrez PY - 2009/12/17/pubmed PY - 2010/5/21/medline SP - 333 EP - 42 JF - Journal of neural transmission (Vienna, Austria : 1996) JO - J Neural Transm (Vienna) VL - 117 IS - 3 N2 - 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. SN - 1435-1463 UR - https://www.unboundmedicine.com/medline/citation/20013007/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_ L2 - https://doi.org/10.1007/s00702-009-0344-4 DB - PRIME DP - Unbound Medicine ER -