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 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.
| Original language | English |
|---|---|
| Article number | 17 |
| Journal | BMC Neurology |
| Volume | 15 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2015 Feb 28 |
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Keywords
- Advanced Parkinson's disease
- Dual therapy
- Oral dopamine receptor agonist
- Rotigotine transdermal system
- Safety
ASJC Scopus subject areas
- Clinical Neurology
Cite this
Rotigotine transdermal system as add-on to oral dopamine agonist in advanced Parkinson's disease : An open-label study. / Asia Pacific Rotigotine Add-on Study Group.
In: BMC Neurology, Vol. 15, No. 1, 17, 28.02.2015.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Rotigotine transdermal system as add-on to oral dopamine agonist in advanced Parkinson's disease
T2 - An open-label study
AU - Asia Pacific Rotigotine Add-on Study Group
AU - Kim, Jong Min
AU - Chung, Sun Ju
AU - Kim, Jae Woo
AU - Jeon, Beom Seok
AU - Singh, Pritibha
AU - Thierfelder, Stephan
AU - Ikeda, Junji
AU - Bauer, Lars
AU - Sohn, Young Ho
AU - Lee, Myung Sik
AU - Kim, Sang Jin
AU - Cho, Jin Whan
AU - Kim, Hee Tae
AU - Park, Kun Woo
AU - Lee, Ho Won
AU - Irene, Looi
AU - Abd Aziz, Zariah Bt
AU - Sim, Siew Hung
AU - Tsai, Chon Haw
AU - Zheng, Tian Jun
AU - Wu, Ruey Meei
AU - Schwartz, Raymond
AU - Beran, Roy
AU - Evans, Andrew
AU - Hayes, Michael
AU - Tan, Louis
AU - Tan, Eng King
PY - 2015/2/28
Y1 - 2015/2/28
N2 - 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.
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.
KW - Advanced Parkinson's disease
KW - Dual therapy
KW - Oral dopamine receptor agonist
KW - Rotigotine transdermal system
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=84928722400&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84928722400&partnerID=8YFLogxK
U2 - 10.1186/s12883-015-0267-7
DO - 10.1186/s12883-015-0267-7
M3 - Article
C2 - 25879416
AN - SCOPUS:84928722400
VL - 15
JO - BMC Neurology
JF - BMC Neurology
SN - 1471-2377
IS - 1
M1 - 17
ER -