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

Dirk Woitalla; Antoine Dunac; Ali Safavi; Maria Gabriella Ceravolo; Juan Carlos Gomez Esteban; Nicola Pavese; Mahnaz Asgharnejad; Lars Joeres; Jan Christof Schuller; K. Ray Chaudhuri

doi:10.1080/14656566.2018.1480721

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

Dirk Woitalla^*, Antoine Dunac, Ali Safavi, Maria Gabriella Ceravolo, Juan Carlos Gomez Esteban, Nicola Pavese, Mahnaz Asgharnejad, Lars Joeres, Jan Christof Schuller, K. Ray Chaudhuri

^*Corresponding author for this work

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

8 Citations (Scopus)

Abstract

Background: PD0013 was a 6-month noninterventional study in clinical practice comparing effectiveness/tolerability of rotigotine+levodopa in younger (<70 years) vs. older (≥70 years) Parkinson’s disease (PD) patients. Methods: Patients previously received levodopa for ≥6 months as monotherapy/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 ± 3.4 mg/24h younger vs. 4.9 ± 2.4 mg/24h older. Eleven patients changed levodopa dose. 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/switched from levodopa+another DA, rotigotine led to greater improvement in UPDRS-II in younger patients (<70 years). Individual patient data revealed clinically meaningful improvements in UPDRS-II in both groups.

Original language	English
Journal	Expert Opinion on Pharmacotherapy
Volume	19
Issue	9
Pages (from-to)	937-945
Number of pages	9
ISSN	1465-6566
DOIs	https://doi.org/10.1080/14656566.2018.1480721
Publication status	Published - 2018
Externally published	Yes

Keywords

Add-on therapy
dopamine agonist
levodopa
noninterventional study
Parkinson’s disease
rotigotine
UPDRS II

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10.1080/14656566.2018.1480721

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Woitalla, D., Dunac, A., Safavi, A., Ceravolo, M. G., Gomez Esteban, J. C., Pavese, N., Asgharnejad, M., Joeres, L., Schuller, J. C., & Chaudhuri, K. R. (2018). A noninterventional study evaluating the effectiveness of rotigotine and levodopa combination therapy in younger versus older patients with Parkinson’s disease. Expert Opinion on Pharmacotherapy, 19(9), 937-945. https://doi.org/10.1080/14656566.2018.1480721

@article{42dbbe0ac75e48b08601fec91c413974,

title = "A noninterventional study evaluating the effectiveness of rotigotine and levodopa combination therapy in younger versus older patients with Parkinson{\textquoteright}s disease",

abstract = "Background: PD0013 was a 6-month noninterventional study in clinical practice comparing effectiveness/tolerability of rotigotine+levodopa in younger (<70 years) vs. older (≥70 years) Parkinson{\textquoteright}s disease (PD) patients. Methods: Patients previously received levodopa for ≥6 months as monotherapy/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 ± 3.4 mg/24h younger vs. 4.9 ± 2.4 mg/24h older. Eleven patients changed levodopa dose. 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/switched from levodopa+another DA, rotigotine led to greater improvement in UPDRS-II in younger patients (<70 years). Individual patient data revealed clinically meaningful improvements in UPDRS-II in both groups.",

keywords = "Add-on therapy, dopamine agonist, levodopa, noninterventional study, Parkinson{\textquoteright}s disease, rotigotine, UPDRS II",

author = "Dirk Woitalla and Antoine Dunac and Ali Safavi and Ceravolo, {Maria Gabriella} and {Gomez Esteban}, {Juan Carlos} and Nicola Pavese and Mahnaz Asgharnejad and Lars Joeres and Schuller, {Jan Christof} and Chaudhuri, {K. Ray}",

year = "2018",

doi = "10.1080/14656566.2018.1480721",

language = "English",

volume = "19",

pages = "937--945",

journal = "Expert Opinion on Pharmacotherapy",

issn = "1465-6566",

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Woitalla, D, Dunac, A, Safavi, A, Ceravolo, MG, Gomez Esteban, JC, Pavese, N, Asgharnejad, M, Joeres, L, Schuller, JC & Chaudhuri, KR 2018, 'A noninterventional study evaluating the effectiveness of rotigotine and levodopa combination therapy in younger versus older patients with Parkinson’s disease', Expert Opinion on Pharmacotherapy, vol. 19, no. 9, pp. 937-945. https://doi.org/10.1080/14656566.2018.1480721

A noninterventional study evaluating the effectiveness of rotigotine and levodopa combination therapy in younger versus older patients with Parkinson’s disease. / Woitalla, Dirk; Dunac, Antoine; Safavi, Ali et al.
In: Expert Opinion on Pharmacotherapy, Vol. 19, No. 9, 2018, p. 937-945.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

TY - JOUR

T1 - A noninterventional study evaluating the effectiveness of rotigotine and levodopa combination therapy in younger versus older patients with Parkinson’s disease

AU - Woitalla, Dirk

AU - Dunac, Antoine

AU - Safavi, Ali

AU - Ceravolo, Maria Gabriella

AU - Gomez Esteban, Juan Carlos

AU - Pavese, Nicola

AU - Asgharnejad, Mahnaz

AU - Joeres, Lars

AU - Schuller, Jan Christof

AU - Chaudhuri, K. Ray

PY - 2018

Y1 - 2018

N2 - Background: PD0013 was a 6-month noninterventional study in clinical practice comparing effectiveness/tolerability of rotigotine+levodopa in younger (<70 years) vs. older (≥70 years) Parkinson’s disease (PD) patients. Methods: Patients previously received levodopa for ≥6 months as monotherapy/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 ± 3.4 mg/24h younger vs. 4.9 ± 2.4 mg/24h older. Eleven patients changed levodopa dose. 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/switched from levodopa+another DA, rotigotine led to greater improvement in UPDRS-II in younger patients (<70 years). Individual patient data revealed clinically meaningful improvements in UPDRS-II in both groups.

AB - Background: PD0013 was a 6-month noninterventional study in clinical practice comparing effectiveness/tolerability of rotigotine+levodopa in younger (<70 years) vs. older (≥70 years) Parkinson’s disease (PD) patients. Methods: Patients previously received levodopa for ≥6 months as monotherapy/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 ± 3.4 mg/24h younger vs. 4.9 ± 2.4 mg/24h older. Eleven patients changed levodopa dose. 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/switched from levodopa+another DA, rotigotine led to greater improvement in UPDRS-II in younger patients (<70 years). Individual patient data revealed clinically meaningful improvements in UPDRS-II in both groups.

KW - Add-on therapy

KW - dopamine agonist

KW - levodopa

KW - noninterventional study

KW - Parkinson’s disease

KW - rotigotine

KW - UPDRS II

UR - http://www.scopus.com/inward/record.url?scp=85048776723&partnerID=8YFLogxK

U2 - 10.1080/14656566.2018.1480721

DO - 10.1080/14656566.2018.1480721

M3 - Journal article

C2 - 29916262

AN - SCOPUS:85048776723

SN - 1465-6566

VL - 19

SP - 937

EP - 945

JO - Expert Opinion on Pharmacotherapy

JF - Expert Opinion on Pharmacotherapy

IS - 9

ER -

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

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