Opicapone Use in Clinical Practice across Germany: A Sub-Analysis of the OPTIPARK Study in Parkinson's Disease Patients with Motor Fluctuations.


Journal

European neurology
ISSN: 1421-9913
Titre abrégé: Eur Neurol
Pays: Switzerland
ID NLM: 0150760

Informations de publication

Date de publication:
2022
Historique:
received: 04 11 2021
accepted: 16 02 2022
pubmed: 30 3 2022
medline: 24 9 2022
entrez: 29 3 2022
Statut: ppublish

Résumé

The OPTIPARK study confirmed the effectiveness and safety of opicapone as adjunct therapy to levodopa in patients with Parkinson's disease (PD) and motor fluctuations under real-world conditions. The aim of this sub-analysis was to evaluate opicapone in the German patient cohort of OPTIPARK in order to provide country-specific data. OPTIPARK was an open-label, single-arm study conducted in routine clinical practice across Germany and the UK. Patients with PD and motor fluctuations received once-daily opicapone 50 mg for 3 months in addition to levodopa. The primary endpoint was Clinicians' Global Impression of Change (CGI-C). Secondary assessments included Patients' Global Impressions of Change (PGI-C), Unified Parkinson's Disease Rating Scale (UPDRS) I-IV, Parkinson's Disease Questionnaire (PDQ-8), and Non-Motor Symptoms Scale (NMSS). This sub-analysis reports outcomes from the German patients only. Overall, 363 (97.6%) of the 372 patients included in the German cohort received ≥1 dose of opicapone and 291 (80.2%) completed the study. Improvements on CGI-C and PGI-C were reported by 70.8% and 76.3% of patients, respectively. UPDRS scores improved for activities of daily living during OFF time by -3.3 ± 4.5 points and motor scores during ON time by -5.3 ± 7.9 points. PDQ-8 and NMSS scores also demonstrated improvements. Treatment emergent adverse events considered at least possibly related to opicapone occurred in 37.7% of patients, with most being of mild or moderate intensity. Opicapone added to levodopa in patients with PD and motor fluctuations was effective and generally well tolerated in routine clinical practice across Germany.

Identifiants

pubmed: 35350024
pii: 000523771
doi: 10.1159/000523771
doi:

Substances chimiques

Antiparkinson Agents 0
Oxadiazoles 0
Levodopa 46627O600J
opicapone Y5929UIJ5N

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

389-397

Informations de copyright

© 2022 The Author(s). Published by S. Karger AG, Basel.

Auteurs

Heinz Reichmann (H)

Department of Neurology, University of Dresden, Dresden, Germany.

Karla Eggert (K)

Department of Neurology, Philipps-University of Marburg, Marburg, Germany.

Christian Oehlwein (C)

Medical Center Zwötzen, Gera, Germany.

Tobias Warnecke (T)

Department of Neurology, University of Münster, Münster, Germany.

Andrew J Lees (AJ)

University College London, Reta Lila Weston Institute, London, Great Britain.

Michael Kemmer (M)

BIAL Deutschland GMBH, Mörfelden-Walldorf, Germany.

Patrício Soares-da-Silva (P)

BIAL - Portela & Ca S.A., Coronado, Portugal.
MedInUP, Center for Drug Discovery and Innovative Medicines, University of Porto, Porto, Portugal.

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Classifications MeSH