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

Research output: Contribution to journalArticle

6 Citations (Scopus)

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 languageEnglish
Article number17
JournalBMC Neurology
Volume15
Issue number1
DOIs
Publication statusPublished - 2015 Feb 28

Fingerprint

Dopamine Agonists
Parkinson Disease
Sleep
Levodopa
Nasopharyngitis
Safety
Orthostatic Hypotension
N 0437
Dyskinesias
Dizziness
Therapeutics
Pruritus
Activities of Daily Living
Drug-Related Side Effects and Adverse Reactions
Nausea
Pharmacokinetics
Pharmacology

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 journalArticle

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title = "Rotigotine transdermal system as add-on to oral dopamine agonist in advanced Parkinson's disease: An open-label study",
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.",
keywords = "Advanced Parkinson's disease, Dual therapy, Oral dopamine receptor agonist, Rotigotine transdermal system, Safety",
author = "{Asia Pacific Rotigotine Add-on Study Group} and Kim, {Jong Min} and Chung, {Sun Ju} and Kim, {Jae Woo} and Jeon, {Beom Seok} and Pritibha Singh and Stephan Thierfelder and Junji Ikeda and Lars Bauer and Sohn, {Young Ho} and Lee, {Myung Sik} and Kim, {Sang Jin} and Cho, {Jin Whan} and Kim, {Hee Tae} and Park, {Kun Woo} and Lee, {Ho Won} and Looi Irene and {Abd Aziz}, {Zariah Bt} and Sim, {Siew Hung} and Tsai, {Chon Haw} and Zheng, {Tian Jun} and Wu, {Ruey Meei} and Raymond Schwartz and Roy Beran and Andrew Evans and Michael Hayes and Louis Tan and Tan, {Eng King}",
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volume = "15",
journal = "BMC Neurology",
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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

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