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Rotigotine transdermal system as add-on to oral dopamine agonist in advanced Parkinsons disease: an open-label study
DC Field | Value | Language |
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dc.contributor.author | Kim, Jong-Min | - |
dc.contributor.author | Chung, Sun Ju | - |
dc.contributor.author | Kim, Jae Woo | - |
dc.contributor.author | Jeon, Beom Seok | - |
dc.contributor.author | Singh, Pritibha | - |
dc.contributor.author | Thierfelder, Stephan | - |
dc.contributor.author | Ikeda, Junji | - |
dc.contributor.author | Bauer, Lars | - |
dc.date.accessioned | 2017-02-08T05:30:49Z | - |
dc.date.available | 2017-02-08T05:30:49Z | - |
dc.date.issued | 2015-02-28 | - |
dc.identifier.citation | BMC Neurology, 15(1):17 | ko_KR |
dc.identifier.uri | https://hdl.handle.net/10371/100549 | - |
dc.description | This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. | ko_KR |
dc.description.abstract | Abstract
Background Achieving optimal symptom control with minimal side effects is a major goal in clinical practice. Dual-agent dopamine receptor agonist (DA) therapy in Parkinsons disease (PD) may represent a promising approach to treatment, as the combination of different pharmacokinetic/pharmacological profiles may result in a lesser need for high dosages and, accordingly, may be well tolerated. The objective of the current study was to investigate safety and efficacy of rotigotine transdermal system as add-on to oral DA in patients with advanced PD inadequately controlled with levodopa and low-dose oral DA. Methods PD0015 was an open-label, multinational study in patients with advanced-PD and sleep disturbance or early-morning motor impairment. Patients were titrated to optimal dose rotigotine (≤8mg/24h) over 1–4 weeks and maintained for 4–7 weeks (8-week treatment). Dosage of levodopa and oral DA (pramipexole ≤1.5mg/day, ropinirole ≤6.0mg/day) was stable. Primary variable was Clinical Global Impressions (CGI) item 4: side effects, assessing safety. Other variables included adverse events (AEs), Patient Global Impressions of Change (PGIC), Unified Parkinsons Disease Rating Scale (UPDRS) II and III, Parkinsons Disease Sleep Scale (PDSS-2), Pittsburgh Sleep Quality Index (PSQI), and off time. Results Of 90 patients who received rotigotine, 79 (88%) completed the study; 5 (6%) withdrew due to AEs. Most (83/89; 93%) had a CGI-4 score <3 indicating that rotigotine add-on therapy did not interfere with functioning; 6 (7%) experienced drug-related AEs that interfered with functioning (score ≥3). AEs occurring in ≥5% were application site pruritus (13%), dizziness (10%), orthostatic hypotension (10%), nausea (8%), dyskinesia (8%), and nasopharyngitis (6%). Numerical improvements in motor function (UPDRS III), activities of daily living (UPDRS II), sleep disturbances (PDSS-2, PSQI), and reduction in off time were observed. The majority (71/88; 81%) improved on PGIC. Conclusions Addition of rotigotine transdermal system to low-dose oral DA in patients with advanced-PD was feasible and may be associated with clinical benefit. Trial registration ClinicalTrials.gov identifier NCT01723904 . Trial registration date: November 6, 2012. | ko_KR |
dc.language.iso | en | ko_KR |
dc.publisher | BioMed Central | ko_KR |
dc.subject | Advanced Parkinson’s disease | ko_KR |
dc.subject | Dual therapy | ko_KR |
dc.subject | Rotigotine transdermal system | ko_KR |
dc.subject | Oral dopamine receptor agonist | ko_KR |
dc.subject | Safety | ko_KR |
dc.title | Rotigotine transdermal system as add-on to oral dopamine agonist in advanced Parkinsons disease: an open-label study | ko_KR |
dc.type | Article | ko_KR |
dc.contributor.AlternativeAuthor | 김종민 | - |
dc.contributor.AlternativeAuthor | 정선주 | - |
dc.contributor.AlternativeAuthor | 김재우 | - |
dc.contributor.AlternativeAuthor | 전범석 | - |
dc.identifier.doi | 10.1186/s12883-015-0267-7 | - |
dc.language.rfc3066 | en | - |
dc.rights.holder | Kim et al.; licensee BioMed Central. | - |
dc.date.updated | 2017-01-06T10:15:58Z | - |
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