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
N1 - Funding Information:
Acknowledgments This study was supported by UCB Pharma, Monheim am Rhein, Germany, and Otsuka Pharmaceutical Company, Ltd. Tokyo, Japan. The sponsors were involved in the design of the study, the analysis and interpretation of data, and in the decision to submit the paper for publication. The authors acknowledge the Asia Pacific Rotigotine Add-on Study Group for their contributions to data acquisition; Korea: Young-Ho Sohn (Severance Hospital), Myung Sik Lee (Gangnam Severance Hospital), Sun Ju Chung (Asan Medical Center), Sang Jin Kim (Inje University Busan Paik Hospital), Jin Whan Cho (Samsung Medical Center), Hee Tae Kim (Hanyang University Hospital), Kun Woo Park (Korea University Anam Hospital), Ho-Won Lee (Kyungpook National University Medical Center), Beom Seok Jeon (Seoul National University Hospital), Jong Min Kim (Seoul National University Bundang Hospital), Jae Woo Kim (Dong-A University Medical Center); Malaysia: Looi Irene (Hospital Seberang Jaya), Zariah Bt Abd Aziz (Hospital Sultanah Nur Zahirah), Siew Hung Sim (Hospital Umum Sarawak); Taiwan: Chon-Haw Tsai (China Medical University Hospital), Tian-Jun Zheng (ChiMei Medical Center-Yongkang), Ruey-Meei Wu (National Taiwan University Hospital); Australia: Raymond Schwartz (Southern Neurology St George Private Hospital), Roy Beran (Strategic Health Evaluators), Andrew Evans (Flemington Neurology), Michael Hayes (Concord Hospital); Singapore: Louis Tan (National Neuroscience Institute), Eng King Tan (Singapore General Hospital). The authors also acknowledge Emily Thompson, PhD, Evidence Scientific Solutions, London, UK, for writing and editorial assistance towards the development of the manuscript, which was funded by UCB Pharma, Brussels, Belgium, and Azita Tofighy, Publications Manager, UCB Pharma, Brussels, Belgium, for publication coordination.
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
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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 -