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Subcutaneous Levodopa Infusion for Parkinson's Disease: 1‐Year Data from the Open‐Label BeyoND Study
Movement disorders, 2021-11, Vol.36 (11), p.2687-2692
Poewe, Werner
Stocchi, Fabrizio
Arkadir, David
Ebersbach, Georg
Ellenbogen, Aaron L.
Giladi, Nir
Isaacson, Stuart H.
Kieburtz, Karl
LeWitt, Peter
Olanow, C. Warren
Simuni, Tanya
Thomas, Astrid
Zlotogorski, Abraham
Adar, Liat
Case, Ryan
Oren, Sheila
Fuchs Orenbach, Shir
Rosenfeld, Olivia
Sasson, Nissim
Yardeni, Tami
Espay, Alberto J.
2021
Volltextzugriff (PDF)
Details
Autor(en) / Beteiligte
Poewe, Werner
Stocchi, Fabrizio
Arkadir, David
Ebersbach, Georg
Ellenbogen, Aaron L.
Giladi, Nir
Isaacson, Stuart H.
Kieburtz, Karl
LeWitt, Peter
Olanow, C. Warren
Simuni, Tanya
Thomas, Astrid
Zlotogorski, Abraham
Adar, Liat
Case, Ryan
Oren, Sheila
Fuchs Orenbach, Shir
Rosenfeld, Olivia
Sasson, Nissim
Yardeni, Tami
Espay, Alberto J.
Titel
Subcutaneous Levodopa Infusion for Parkinson's Disease: 1‐Year Data from the Open‐Label BeyoND Study
Ist Teil von
Movement disorders, 2021-11, Vol.36 (11), p.2687-2692
Ort / Verlag
Hoboken, USA: John Wiley & Sons, Inc
Erscheinungsjahr
2021
Quelle
MEDLINE
Beschreibungen/Notizen
ABSTRACT Background Continuous, subcutaneous (SC) levodopa/carbidopa infusion with ND0612 is under development as a treatment for patients with Parkinson's disease (PD) and motor fluctuations. Objective Evaluate 1‐year safety data. Methods BeyoND is an open‐label study evaluating the long‐term safety of two ND0612 dosing regimens. Results Of the 214 enrolled patients (24‐hour SC infusion: n = 90; 16‐hour SC infusion: n = 124), 120 (56%) completed 12 months of treatment. Leading causes for study discontinuation were consent withdrawal (19.6%) and adverse events (17.3%). Rates of discontinuation were reduced from 49% to 29% after a protocol revision and retraining. Systemic safety was typical for PD patients treated with levodopa/carbidopa. Most patients experienced infusion site reactions, particularly nodules (30.8%) and hematoma (25.2%), which were judged mostly mild to moderate and led to discontinuation in only 10.3% of the participants. Conclusions Subcutaneous levodopa/carbidopa continuous infusion with ND0612 is generally safe, with typical infusion site reactions for SC delivery as the main adverse event. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society
Sprache
Englisch
Identifikatoren
ISSN: 0885-3185
eISSN: 1531-8257
DOI: 10.1002/mds.28758
Titel-ID: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9291977
Format
–
Schlagworte
Adverse events
,
Antiparkinson Agents - adverse effects
,
Brief Report
,
Carbidopa - adverse effects
,
Drug Combinations
,
Gels
,
Hematoma
,
Humans
,
infusion
,
Levodopa
,
Levodopa - adverse effects
,
Movement disorders
,
ND0612
,
Neurodegenerative diseases
,
Parkinson Disease - drug therapy
,
Parkinson's disease
,
Patients
,
Regular Issue
,
Safety
,
subcutaneous
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