Efficacy, safety, and tolerability of pramipexole in untreated and levodopa-treated patients with Parkinson's disease

Wong, Ka Sing; Lu, Chin‐Song; Shan, Din‐E; Yang, Chih‐Chao; Tsoi, Tak Hong; Mok, Vincent

doi:10.1016/s0022-510x(03)00217-x

Cited by 47 publications

(39 citation statements)

References 6 publications

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“…An earlier study of pramipexole in Chinese patients with early or advanced PD in Hong Kong and Taiwan showed that pramipexole is safe and well-tolerated [15]. We found similar safety profiles of ER and IR tablets with no unexpected safety risks.…”

Section: Discussionsupporting

confidence: 72%

The efficacy and safety of pramipexole ER versus IR in Chinese patients with Parkinson’s disease: a randomized, double-blind, double-dummy, parallel-group study

Wang

Sun

Zhu

et al. 2014

Transl Neurodegener

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ObjectiveTo evaluate the non-inferiority of pramipexole extended-release (ER) versus immediate-release (IR) in Chinese patients with Parkinson’s disease (PD) in a double-blind, randomized, parallel-group study.MethodsSubjects were Chinese patients with idiopathic PD with diagnosis ≥ 2 years prior to trial, age ≥ 30 years old at diagnosis, and Modified Hoehn and Yahr score 2-4 during ‘on’-time. Subjects received treatment with pramipexole ER (n=234) or IR (n=239). Non-inferiority was based on the primary endpoint, the change from baseline to end of maintenance (week 18) in the UPDRS (Parts II + III) total score.ResultsFor the primary endpoint, the adjusted mean changes (standard error) of UPDRS Parts II + III at week 18 were -13.81 (0.655) and -13.05 (0.643) for ER and IR formulations, respectively, using ANCOVA adjusted for treatment and centre (fixed effect) and baseline (covariate). The adjusted mean between group difference was 0.8 for the 2-sided 95% CI (-1.047, 2.566). Since the lower limit of the 2-sided 95% CI (-1.047) for treatment difference was higher than the non-inferiority margin of -4, non-inferiority between pramipexole ER and IR was demonstrated. The incidence of adverse events (AEs) was 68.8% in the ER arm and 73.6% in the IR arm with few severe AEs (ER: 2.1%; IR: 3.8%).ConclusionBased on the UPDRS II + III score, pramipexole ER was non-inferior to pramipexole IR. The safety profiles of pramipexole ER and IR were similar. These results were based on comparable mean daily doses and durations of treatment for both formulations.

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Section: Discussionsupporting

confidence: 72%

The efficacy and safety of pramipexole ER versus IR in Chinese patients with Parkinson’s disease: a randomized, double-blind, double-dummy, parallel-group study

Wang

Sun

Zhu

et al. 2014

Transl Neurodegener

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“…However all other auxiliary treatments also suffer from several side-effects. These range from confusion, drowsiness, agitation, and hallucinations for anticholinergics to psychiatric disturbances, and cardiovascular problems with dopamine agonist use [35]. Thus the use of herbal therapeutics for PD is the need of the hour.…”

Section: Discussionmentioning

confidence: 99%

Complete Comparison Display (CCD) evaluation of ethanol extracts of Centella asiatica and Withania somnifera shows that they can non-synergistically ameliorate biochemical and behavioural damages in MPTP induced Parkinson's model of mice

et al. 2017

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Parkinson’s disease remains as one of the most common debilitating neurodegenerative disorders. With the hopes of finding agents that can cure or reduce the pace of progression of the disease, we studied two traditional medicinal plants: Centella asiatica and Withania somnifera that have been explored in some recent studies. In agreement with the previous work on ethanol extracts of these two plants in mice model, we saw an improvement in oxidative stress profile as well as behavioral performance in 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) induced Parkinson-like symptoms in Balb/c mice. Given the known potential of both the herbal extracts in improving Parkinson-like symptoms, we expected the combination of the two to show better results than either of the two but surprisingly there was no additivity in either oxidative stress or behavioural recovery. In fact, in some assays, the combination performed worse than either of the two individual constituents. This effect of mixtures highlights the need of testing mixtures in supplements market using enthomedicine. The necessity of comparing multiple groups in this study to get most information from the experiments motivated us to design a ladder-like visualization to show comparison with different groups that we call complete comparison display (CCD). In summary, we show the potential of Centella asiatica and Withania somnifera to ameliorate Parkinson’s disorder.

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“…Pramipexole patches containing different drug concentrations (3,6,10,15,20,25, and 30%, w/w) were prepared and stored at 40 ± 2°C, 75 ± 5% relative humidity in a temperature humidity chamber (Yongsheng Experiment Equipment Factory, Chongqing, China). Samples were withdrawn at 1, 2, 3, and 6 months and observed under an XSP-5 optical microscope (Shanghai Optical Instrument Factory, China).…”

Section: Rug Loading Capacity and Drug Stabilitymentioning

confidence: 99%

“…Pramipexole (Fig. 1) is a highly active dopamine receptor agonist and has been widely used as a first-line drug for the treatment of early and advanced PD due to its long-term efficacy, safety, and tolerability (6,7). However, the oral pharmacokinetics of pramipexole (PPX) shows a short half-life (t 1/2 ) of only 8-12 h in human (8)(9)(10).…”

Section: Introductionmentioning

confidence: 99%

Development of a Prolonged-Release Pramipexole Transdermal Patch: In Vitro and In Vivo Evaluation

Sun

et al. 2016

AAPS PharmSciTech

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The current study aimed to develop a prolonged-release pramipexole (PPX) transdermal patch for the treatment of Parkinson's disease. Permeation parameters of PPX were investigated using human cadaver skin. Pramipexole patches were prepared using DURO-TAK pressure-sensitive-adhesive (PSA) and evaluated for drug stability, drug loading, in vitro drug release, and in vitro permeation through mouse skin. The results indicated that blends of DURO-TAK 87-2852 and DURO-TAK 87-2510 were suitable for creating a prolonged-release PPX patch due to their advantages in drug release, drug loading, and stability. The final formulation consisted of 87-2852/87-2510 (70:30), 10% PG, and 15% PPX and showed a cumulative permeation amount of 1497.19 ± 102.90 μg/cm with a continuous flux over 6.0 μg/(cm·h) across human cadaver skin for 7 days. In vivo studies in rats indicated that PPX patch produced a significantly longer (p < 0.001) half-life (t , 75.16 ± 17.37 h) and mean residence time (MRT, 135.89 ± 24.12 h) relative to oral tablets (Sifrol) and had a relative bioavailability of 51.64 ± 21.32%. Therefore, this study demonstrated the feasibility of developing a prolonged-release PPX patch, which proposed the potential to serve as an alternate to conventional oral tablets and may therefore improve patient compliance.

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Efficacy, safety, and tolerability of pramipexole in untreated and levodopa-treated patients with Parkinson's disease

Cited by 47 publications

References 6 publications

The efficacy and safety of pramipexole ER versus IR in Chinese patients with Parkinson’s disease: a randomized, double-blind, double-dummy, parallel-group study

The efficacy and safety of pramipexole ER versus IR in Chinese patients with Parkinson’s disease: a randomized, double-blind, double-dummy, parallel-group study

Complete Comparison Display (CCD) evaluation of ethanol extracts of Centella asiatica and Withania somnifera shows that they can non-synergistically ameliorate biochemical and behavioural damages in MPTP induced Parkinson's model of mice

Development of a Prolonged-Release Pramipexole Transdermal Patch: In Vitro and In Vivo Evaluation

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