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Early versus delayed initiation of entacapone in levodopa-treated patients with Parkinson’s disease: a long-term, retrospective analysis

  1. H. Nissinen1,
  2. M. Kuoppamäki2,3,
  3. M. Leinonen4,
  4. A. H. Schapira5

Article first published online: 30 JUN 2009

DOI: 10.1111/j.1468-1331.2009.02726.x

Issue

European Journal of Neurology

European Journal of Neurology

Volume 16, Issue 12, pages 1305–1311, December 2009

Additional Information

How to Cite

Nissinen, H., Kuoppamäki, M., Leinonen, M. and Schapira, A. H. (2009), Early versus delayed initiation of entacapone in levodopa-treated patients with Parkinson’s disease: a long-term, retrospective analysis. European Journal of Neurology, 16: 1305–1311. doi: 10.1111/j.1468-1331.2009.02726.x

Author Information

  1. 1

    Orion Pharma, Espoo, Finland

  2. 2

    Orion Pharma, Turku, Finland

  3. 3

    Department of Neurology, Turku University Hospital, University of Turku, Turku, Finland

  4. 4

    4Pharma AB, Kista, Sweden

  5. 5

    University Department of Clinical Neurosciences, Institute of Neurology, University College London, National Hospital for Neurology and Neurosurgery and Royal Free Hospital, London, UK

*Helena Nissinen, MD, Orion Corporation Orion Pharma, Orionintie 1, PO Box 65, FI-02101 Espoo, Finland (tel.: +358 10 426 4806; fax: +358 10 426 3815; e-mail: helena.nissinen@orionpharma.com).

Publication History

  1. Issue published online: 17 NOV 2009
  2. Article first published online: 30 JUN 2009
  3. Received 16 January 2009 Accepted 19 May 2009

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Keywords:

  • entacapone;
  • levodopa;
  • Parkinson’s disease;
  • wearing-off

Background:  We analysed data from three clinical trials in Parkinson’s disease (PD) patients with wearing-off to determine whether early enhancement of levodopa therapy with entacapone can lead to better long-term outcomes than delayed entacapone treatment.

Methods: Post-hoc analysis of pooled data from three randomized, double-blind, placebo-controlled studies and their long-term, open-label extension phases. In all three studies, patients on levodopa/dopa-decarboxylase inhibitor (DDCI) were first randomized to entacapone (‘early-start’ group) or placebo (‘delayed-start’ group) for the initial 6-month double-blind phase, after which all patients received open-label levodopa/DDCI and entacapone treatment for up to 5 years.

Results:  A total of 488 PD patients with wearing-off were included in the analysis. A statistically significant benefit of early initiation of levodopa/DDCI and entacapone was found, with an improvement in Unified Parkinson’s Disease Rating Scale Part III (motor) score of −1.66 (95% confidence intervals [−3.01, −0.31]) points compared with the delayed-start treatment group (P < 0.05). Levodopa/DDCI and entacapone therapy was well tolerated. There was no excess of dyskinesia in the early-start group.

Conclusions:  These data suggest that early rather than delayed addition of entacapone to levodopa/DDCI in PD patients with wearing-off provides a modest clinical benefit over levodopa/DDCI that is maintained for up to 5 years.

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