Rotigotine transdermal patch in Chinese patients with advanced Parkinson's disease: A randomized, double-blind, placebo-controlled pivotal study

Zhang, Zhenxin; Liu, Chunfeng; Tao, Enxiang; Shao, Ming; Liu, Yiming; Wang, Jian; Asgharnejad, Mahnaz; Han, Xue; Surmann, Erwin; Bauer, Lars

doi:10.1016/j.parkreldis.2017.08.015

Cited by 18 publications

(7 citation statements)

References 18 publications

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“…In this meta-analysis, 20 eligible RCTs involving 6,560 patients were included (Supplementary Appendix 2). The included PD patients with motor fluctuations received eight different treatments (Guttman, 1997;Pinter et al, 1999;Mizuno et al, 2003Mizuno et al, , 2007Mizuno et al, , 2012Wong et al, 2003;Möller et al, 2005;Barone et al, 2007;Poewe et al, 2007;Hersh et al, 2010;Schapira et al, 2011;Stocchi et al, 2011;Zhang et al, 2013Zhang et al, , 2017Nicholas et al, 2014;Nomoto et al, 2014;Wang et al, 2014;Zesiewicz et al, 2017;Katzenschlager et al, 2018).…”

Section: Systematic Review and Characteristicsmentioning

confidence: 99%

Comparative Efficacy and Safety of Dopamine Agonists in Advanced Parkinson's Disease With Motor Fluctuations: A Systematic Review and Network Meta-Analysis of Double-Blind Randomized Controlled Trials

Ruan

Lin

et al. 2021

Front. Neurosci.

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Background: Movement fluctuations are the main complication of Parkinson's disease (PD) patients receiving long-term levodopa (L-dopa) treatment. We compared and ranked the efficacy and safety of dopamine agonists (DAs) with regard to motor fluctuations by using a Bayesian network meta-analysis (NMA) to quantify information from randomized controlled trials (RCTs).Methods and Findings: We carried out a systematic review and meta-analysis, and only RCTs comparing DAs for advanced PD were included. Electronic databases (PubMed, Embase, and Cochrane Library) were systematically searched for relevant studies published until January 2021. Two reviewers independently extracted individual study data and evaluated studies for risk of bias using the Cochrane Risk of Bias tool. Network meta-analyses using a Bayesian framework were used to calculate the related parameters. The pre-specified primary and secondary outcomes were efficacy (“ON” time without troublesome dyskinesia, “OFF” time, “ON” time, “UPDRS-III,” and “UPDRS-II”) and safety [treatment-emergent adverse events (TEAE) and other adverse events] of DAs. The results are presented as the surface under the cumulative ranking (SUCRA) curve. A total of 20 RCTs assessing 6,560 patients were included. The general DA effects were ranked from high to low with respect to the amount of “ON” time without troublesome dyskinesia as follows: apomorphine (SUCRA = 97.08%), pramipexole_IR (probability = 79.00%), and ropinirole_PR (SUCRA = 63.92%). The general safety of DAs was ranked from high to low with respect to TEAE as follows: placebo (SUCRA = 74.49%), pramipexole_ER (SUCRA = 63.6%), sumanirole (SUCRA = 54.07%), and rotigotine (SUCRA = 53.84%).Conclusions: This network meta-analysis shows that apomorphine increased “ON” time without troublesome dyskinesia and decreased “OF” time for advanced PD patients. The addition of pramipexole, ropinirole, or rotigotine to levodopa treatment in advanced PD patients with motor fluctuations increased “ON” time without troublesome dyskinesia, improved the UPDRS III scores, and ultimately ameliorated the UPDRS II scores, thereby maximizing its benefit. This NMA of pramipexole, ropinirole, and rotigotine represents an effective treatment option and has an acceptable safety profile in patients with advanced PD.

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Section: Systematic Review and Characteristicsmentioning

confidence: 99%

Comparative Efficacy and Safety of Dopamine Agonists in Advanced Parkinson's Disease With Motor Fluctuations: A Systematic Review and Network Meta-Analysis of Double-Blind Randomized Controlled Trials

Ruan

Lin

et al. 2021

Front. Neurosci.

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“…Both the PDSS and PDQ-39 have been validated in the Chinese language [ 11 – 13 ]. In 2011, the 2nd version of the PDSS (PDSS-2) was developed [ 14 ]; this has been validated in patients from Austria, Germany and the UK [ 15 ], and used in previous studies in Chinese patients [ 16 , 17 ]; however, to our knowledge, the PDSS-2 has not been validated in the Chinese language to date.…”

Section: Introductionmentioning

confidence: 99%

Prevalence and profile of nocturnal disturbances in Chinese patients with advanced-stage Parkinson’s disease: a cross-sectional epidemiology study

Liu

et al. 2021

BMC Neurol

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Background The impact of nocturnal disturbance (ND) in Parkinson’s disease on quality of life of patients in Western Countries is increasingly understood. Our study aimed to investigate ND prevalence and its quality of life impact in patients with advanced Parkinson’s disease in China. Methods In a multicenter, tertiary-care hospital, outpatient-based, cross-sectional study, patients with advanced Parkinson’s disease (Modified Hoehn & Yahr [H&Y] Stage II–IV with ≥3 h awake “off” time/day) from 10 tertiary hospitals throughout China completed the Parkinson’s Disease Sleep Scale-2 (PDSS-2) and Parkinson’s Disease Questionnaire-39 (PDQ-39). The primary endpoint was the percentage of patients with significant ND (PDSS-2 total score ≥ 15). Additional endpoints were demographic and clinical characteristics, PDSS-2 and PDQ-39 total and subscale scores, correlation between PDSS-2 and PDQ-39, and risk factors for ND and higher PDSS-2 or PDQ-39 scores. Results Of 448 patients analyzed (mean age 63.5 years, 47.3% female), 70.92% (95% confidence interval: 66.71, 75.13) had significant ND. Presence of ND and higher PDSS-2 scores were associated with longer disease duration and higher H&Y stage. Presence of ND was also associated with more awake “off” time/day and female sex. PDQ-39 scores were significantly worse for patients with ND versus those without ND; worse scores were associated with more awake “off” time/day, female sex, and higher H&Y stage. PDSS-2 and PDQ-39 total scores were associated: Pearson correlation coefficient 0.62 (p < 0.001). Conclusions In China, ND was highly prevalent in patients with advanced Parkinson’s disease and adversely impacted quality of life. This study highlights the importance of early diagnosis and optimized management of ND in patients with Parkinson’s disease in China.

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“…Other treatments for PD often aim to stimulate similar pathways or increase dopamine in the brain. One such treatment includes levodopa, a chemical precursor to dopamine that unlike dopamine can cross the blood-brain barrier [6][7][8][9][10][11][12]. Prolonged use of levodopa often leads to complications such as PD fluctuation of symptoms and problems with involuntary movements, opening the doorway to combining levodopa treatment with other treatments to combat side effects.…”

Section: Diagnosis Of Parkinson's Diseasementioning

confidence: 99%

A Systematic Review of the Usage of Rotigotine During Early and Advanced Stage Parkinson's

Rajendran¹,

Reddy²,

Bisaga³

et al. 2023

Cureus

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Parkinson's disease (PD) is a prevalent neurodegenerative disorder that occurs in old age due to a decrease in dopamine, which causes nerve cell destruction. This disease is difficult to diagnose since its symptoms are similar to those of the aging process. Those with PD have impaired motor control and function, dyskinesia, and tremors. To treat PD, drugs that enhance the amount of dopamine given to the brain are administered to alleviate symptoms. This inquiry examines the prescription of rotigotine to achieve this objective. The primary objective of this review is to examine the usage of rotigotine in both the late and early stages of PD. The statistical model utilized in the review found that there was not a significant difference in the dosage of rotigotine prescribed to late and early-stage PD patients, however, there were some confounding variables that may have skewed this result; therefore, further research is necessary to validate or nullify this hypothesis.

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Rotigotine transdermal patch in Chinese patients with advanced Parkinson's disease: A randomized, double-blind, placebo-controlled pivotal study

Cited by 18 publications

References 18 publications

Comparative Efficacy and Safety of Dopamine Agonists in Advanced Parkinson's Disease With Motor Fluctuations: A Systematic Review and Network Meta-Analysis of Double-Blind Randomized Controlled Trials

Comparative Efficacy and Safety of Dopamine Agonists in Advanced Parkinson's Disease With Motor Fluctuations: A Systematic Review and Network Meta-Analysis of Double-Blind Randomized Controlled Trials

Prevalence and profile of nocturnal disturbances in Chinese patients with advanced-stage Parkinson’s disease: a cross-sectional epidemiology study

A Systematic Review of the Usage of Rotigotine During Early and Advanced Stage Parkinson's

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