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A noninterventional study evaluating the effectiveness of rotigotine and levodopa combination therapy in younger versus older patients with Parkinson's disease

Lookup NU author(s): Professor Nicola Pavese



This is the authors' accepted manuscript of an article that has been published in its final definitive form by Taylor & Francis, 2018.

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Background: PD0013 was a 6-month non-interventional study in clinical-practice comparing effectiveness and tolerability of rotigotine+levodopa in younger (<70years) vs. older (≥70years) Parkinson’s disease (PD) patients.Methods: Patients previously received levodopa for ≥6-months as monotherapy or in combination with another dopamine-agonist (DA). Primary variable: Unified PD Rating Scale (UPDRS) Part-II change from baseline to end-of-observation-period (EOP).Results: 91 younger/99 older patients started rotigotine; 68 younger/62 older patients completed the study. Most switched from levodopa+another DA. Addition of rotigotine as first DA was more common in older patients (20.2% vs.15.4%). Mean±SD rotigotine-exposure: 6.1±3.4mg/24h younger vs. 4.9±2.4mg/24h older. Eleven patients changed levodopa dose during the study.At EOP, improvement in mean UPDRS-II was greater in younger patients (p=0.0289). UPDRS-II responder-rate (≥20% decrease in UPDRS-II score) was higher in younger patients (42.3% vs. 25.9%). Improvement across age-groups was similar on PD Sleep Scale-2 and Clinical Global Impressions-Improvement Scale. Adverse-drug-reactions (ADRs), and discontinuations because of ADRs, were more common among older patients. There were no new safety-signals.Conclusions: Despite low rotigotine doses, when added to levodopa or switched from levodopa+another DA, rotigotine led to greater improvement in UPDRS-II in younger patients (<70years). Assessment of individual patient data revealed clinically-meaningful improvements in UPDRS-II in both age-groups.

Publication metadata

Author(s): Woitalla D, Dunac A, Safavi A, Ceravolo MG, Gomez Esteban JC, Pavese N, Asgharnejad M, Joeres L, Schuller JC, Chaudhuri KR

Publication type: Article

Publication status: Published

Journal: Expert Opinion on Pharmacotherapy

Year: 2018

Volume: 19

Issue: 9

Pages: 937-945

Online publication date: 19/06/2018

Acceptance date: 21/05/2018

Date deposited: 25/07/2018

ISSN (print): 1465-6566

ISSN (electronic): 1744-7666

Publisher: Taylor & Francis


DOI: 10.1080/14656566.2018.1480721


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