TY  - JOUR
AU  - Kim, J-M
AU  - Chung, SJ
AU  - Kim, JW
AU  - Jeon, BS
AU  - Singh, P
AU  - Thierfelder, S
AU  - Ikeda, J
AU  - Bauer, L
AU  - Asia Pacific Rotigotine Add-on Study Group,
Y2  - 2020/12/21
Y1  - 2015/02/28
SN  - 1471-2377
UR  - http://hdl.handle.net/11343/257041
AB  - BACKGROUND: Achieving optimal symptom control with minimal side effects is a major goal in clinical practice. Dual-agent dopamine receptor agonist (DA) therapy in Parkinson's 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 (≤8 mg/24 h) over 1-4 weeks and maintained for 4-7 weeks (8-week treatment). Dosage of levodopa and oral DA (pramipexole ≤1.5 mg/day, ropinirole ≤6.0 mg/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 Parkinson's Disease Rating Scale (UPDRS) II and III, Parkinson's 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.
LA  - eng
PB  - Springer Science and Business Media LLC
T1  - Rotigotine transdermal system as add-on to oral dopamine agonist in advanced Parkinson's disease: an open-label study.
DO  - 10.1186/s12883-015-0267-7
IS  - BMC Neurology
VL  - 15
IS  - 1
SP  - 17-
L1  - /bitstream/handle/11343/257041/PMC4364324.pdf?sequence=1&isAllowed=y
ER  -