The efficacy and safety of ropinirole prolonged release tablets as adjunctive therapy in Chinese subjects with advanced Parkinson's disease: A multicenter, double-blind, randomized, placebo-controlled study

Zhang, Zhenxin; Wang, Jian; Zhang, Xiaoying; Chen, Shengdi; Wang, Zhenfu; Zhang, Baorong; Liu, Chunfeng; Qu, Qing; Cheng, Yan; Li, Jie; Cao, Haijun; Cai, Meiling; Zhu, Rongxuan

doi:10.1016/j.parkreldis.2013.07.009

Cited by 32 publications

(23 citation statements)

References 16 publications

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“…20 A study conducted in China also revealed a significant difference of the mean change of the UPDRS motor score (adjusted treatment difference: -6.66) between ropinirole tablets and placebo in the mean final dose (11.4 mg/d). 24 In the present study, there was a similarity to the difference of the UPDRS Part III total score between the RT and placebo groups (treatment difference: -5.8) compared with these two studies. Alternatively, the final dose in the present study was lower or similar compared with these two studies.…”

Section: Discussionsupporting

confidence: 63%

Ropinirole Patch Versus Placebo, Ropinirole Extended‐Release Tablet in Advanced Parkinson's Disease

et al. 2020

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Background A dopamine agonist patch is an important treatment option for PD. Objectives A randomized, double‐blind, parallel‐group, placebo‐controlled trial was conducted to evaluate superiority of ropinirole hydrochloride patch over placebo and noninferiority to ropinirole hydrochloride extended‐release tablet. Methods PD patients using levodopa received ropinirole patch (up to 64 mg/d), ropinirole tablets (up to 16 mg/d), or placebo once‐daily (double‐dummy technique). The primary endpoint was the change from baseline in the total score for the UPDRS Part III (on state) at week 16. Results The change of the least squares mean (95% confidence interval) in the UPDRS Part III total score was –9.8 (–10.8 to –8.7) with ropinirole patch, –4.3 (–5.8 to –2.8) with placebo, and –10.1 (–11.2 to –9.1) with ropinirole tablet. The difference between the ropinirole patch and placebo groups was –5.4 (–7.3 to –3.6), demonstrating superiority of the patch over placebo. The difference between the ropinirole patch and tablet groups was 0.3 (–1.2 to 1.8). The upper limit of the 95% confidence interval was smaller than the noninferiority limit of 2.5, demonstrating noninferiority of ropinirole patch to ropinirole tablet. In all three groups, most adverse events were mild or moderate and there were no serious safety concerns. Conclusions Once‐daily ropinirole patch was effective in advanced PD patients, having demonstrated superiority over placebo and noninferiority to ropinirole tablet, without causing serious safety problems. Ropinirole patch can be an alternative option for PD patients. © 2020 International Parkinson and Movement Disorder Society

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Section: Discussionsupporting

confidence: 63%

Ropinirole Patch Versus Placebo, Ropinirole Extended‐Release Tablet in Advanced Parkinson's Disease

et al. 2020

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“…Dopamine Agonists . High‐quality studies reported positive outcomes for pramipexole ER, pramipexole IR, ropinirole IR, rotigotine, and ropinirole PR with conclusions of “efficacious” and “clinically useful” for all. Ropinirole PR and rotigotine (see earlier) were evaluated in open‐label extension studies of prior double‐blind RCTs; the quality of these studies was not scored, but they were considered for new safety issues, of which none were reported.…”

Section: Results and Conclusionmentioning

confidence: 99%

International Parkinson and movement disorder society evidence‐based medicine review: Update on treatments for the motor symptoms of Parkinson's disease

et al. 2018

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“…Twenty-seven studies fulfilled the eligibility criteria for at least one of the outcomes provided for by the meta-analysis protocol (incident heart failure assumed as a primary outcome, all-cause mortality and cardiovascular events taken as secondary endpoints) (Figure 1). Thus, six trials were deemed eligible for heart failure [24,27,32,35,36,41] ( Figure 2), 13 trials were deemed eligible for mortality [21,24,[27][28][29][30][31]34,[36][37][38]43,46] (Figure 3) and 22 trials were judged eligible for cardiovascular events [20][21][22][23][25][26][27][28]30,[32][33][34][35][36][39][40][41][42][43][44][45][46] in this review (Figure 4). Patients with orthostatic hypotension were excluded from most of the trials, as it is a common adverse effect of non-ergot DAs.…”

Section: Resultsmentioning

confidence: 99%

“…For cardiovascular events, 22 out of the 27 trials [20][21][22][23][25][26][27][28]30,[32][33][34][35][36][39][40][41][42][43][44][45][46] reported at least one cardiovascular event; thus, they were judged suitable for inclusion in the meta-analysis. Among the 6,734 PD patients, the mean age was 63.8 years and 41.1% were female.…”

Section: The Use Of Non-ergot Das and Cardiovascular Eventsmentioning

confidence: 99%

Non-Ergot Dopamine Agonists don't Increase the Risk of Heart Failure in Parkinson's disease Patients. A Meta-Analysis of Randomized Controlled Trials

Vecchis¹,

Cantatrione²

2016

J Pharmacovigil

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Background: In recent years, some observational studies suggested that pramipexole, a non-ergot dopamine agonist (DA) used for the treatment of Parkinson's disease (PD), may increase the risk of heart failure (HF). However, the limitations inherent in observational studies made it difficult to determine whether the excess of incident HF was related to the drug or to other determinants. Thus, some concerns remained regarding the increased putative HF risk associated with non-ergot DAs as a class or individually. Method: In our meta-analysis, primary endpoint was the risk of incident HF in patients with PD treated with non-ergot DAs compared to those treated with monotherapy with levodopa. Secondary outcome measures were all-cause mortality and cardiovascular events. For these purposes, only randomized controlled trials (RCTs) were considered, provided that they offered complete outcome data pertaining to the incident HF, all-cause mortality and risk of cardiovascular events. Systematic searches were performed in the databases of PubMed, Embase and ClinicalTrial.gov up to May 2015. The effect size was estimated using the pooled relative risk (RR) of non-ergot DAs versus placebo on incident HF as well as on all-cause mortality or cardiovascular events. Results: Six out of 27 RCTs reported at least one case of incident HF; therefore, we included them in the RR estimate, whereas 13 RCTS were included in the meta-analysis for mortality rates and 22 RCTs were included to evaluate cardiovascular events. Treatment with non-ergot DAs did not reveal an increase in the risk of incident HF as compared with the placebo group (pooled RR: 0.95, 95% CI: 0.30-2.90; p = 0.893). Similarly, patients treated with non-ergot DAs didn't show any significant differences compared to controls with regard to all-cause mortality (pooled RR: 0.617, 95% CI: 0.330-1.153; p = 0.13) as well as with regard to cardiovascular events (pooled RR: 1.067, 95% CI: 0.663-1.717; p = 0.789). Conclusion: The use of non-ergot DAs in PD patients was not associated with an increased risk of incident HF, nor was it shown to increase the overall mortality or the risk of cardiovascular events compared to the PD patients taking monotherapy with levodopa alone. However, larger studies are warranted to confirm the cardiovascular safety of non-ergot DAs for PD management.

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The efficacy and safety of ropinirole prolonged release tablets as adjunctive therapy in Chinese subjects with advanced Parkinson's disease: A multicenter, double-blind, randomized, placebo-controlled study

Cited by 32 publications

References 16 publications

Ropinirole Patch Versus Placebo, Ropinirole Extended‐Release Tablet in Advanced Parkinson's Disease

Ropinirole Patch Versus Placebo, Ropinirole Extended‐Release Tablet in Advanced Parkinson's Disease

International Parkinson and movement disorder society evidence‐based medicine review: Update on treatments for the motor symptoms of Parkinson's disease

Non-Ergot Dopamine Agonists don't Increase the Risk of Heart Failure in Parkinson's disease Patients. A Meta-Analysis of Randomized Controlled Trials

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