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Comparison of nocturnal symptoms in advanced Parkinson’s disease patients with sleep disturbances: pramipexole sustained release versus immediate release formulations

BACKGROUND: Nocturnal symptoms are common in Parkinson’s disease (PD), which greatly affect the quality of life but are often overlooked in clinical settings. Treatment strategies that provide sustained dopaminergic stimulation may have sleep benefits. OBJECTIVE: To investigate the treatment effects...

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Autores principales: Xiang, Wei, Sun, Ya Qing, Teoh, Hui Chin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6037405/
https://www.ncbi.nlm.nih.gov/pubmed/30013321
http://dx.doi.org/10.2147/DDDT.S160300
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author Xiang, Wei
Sun, Ya Qing
Teoh, Hui Chin
author_facet Xiang, Wei
Sun, Ya Qing
Teoh, Hui Chin
author_sort Xiang, Wei
collection PubMed
description BACKGROUND: Nocturnal symptoms are common in Parkinson’s disease (PD), which greatly affect the quality of life but are often overlooked in clinical settings. Treatment strategies that provide sustained dopaminergic stimulation may have sleep benefits. OBJECTIVE: To investigate the treatment effects of pramipexole (PPX) sustained release (SR) versus PPX immediate release (IR) on nocturnal symptoms in advanced PD patients with sleep disturbances. MATERIALS AND METHODS: In this study, the PPX clinical trial (NCT00466167) was retrospectively analyzed for PD Sleep Scale (PDSS) total and domain scores in patients with advanced idiopathic PD receiving either PPX SR or PPX IR, who experienced motor fluctuations while on stable levodopa with a baseline PDSS total score of <90, indicating sleep disturbances. Analysis of covariance test was used to compare the adjusted mean changes at week 18 from baseline between treatment groups, after adjusting for pooled country and baseline scores. RESULTS: A total of 119 patients with PD reported sleep disturbances at baseline (PDSS <90; SR, n=59; IR, n=60). At week 18, patients receiving PPX SR reported numerically greater improvement of sleep disturbance than those receiving PPX IR, although the difference of 6.8 points was not statistically significant (adjusted mean changes in PDSS total score, SR=28.5 versus IR=21.7 points, P=0.165). Patients receiving PPX SR observed a numerically greater adjusted mean change in all PDSS domains compared with PPX IR. The overall proportions of patients with any adverse event were similar between both PPX SR and IR groups (62.7% versus 70.0%). CONCLUSION: Both the PPX formulations showed improvements in nocturnal symptoms in advanced PD patients with sleep disturbances and were generally well tolerated. Given the known pharmacokinetic profile of an SR formulation and numerical advantage in PDSS mean change over IR formulation, these preliminary evidences support future prospectively designed studies to investigate the effects of PPX SR for improved sleep.
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spelling pubmed-60374052018-07-16 Comparison of nocturnal symptoms in advanced Parkinson’s disease patients with sleep disturbances: pramipexole sustained release versus immediate release formulations Xiang, Wei Sun, Ya Qing Teoh, Hui Chin Drug Des Devel Ther Original Research BACKGROUND: Nocturnal symptoms are common in Parkinson’s disease (PD), which greatly affect the quality of life but are often overlooked in clinical settings. Treatment strategies that provide sustained dopaminergic stimulation may have sleep benefits. OBJECTIVE: To investigate the treatment effects of pramipexole (PPX) sustained release (SR) versus PPX immediate release (IR) on nocturnal symptoms in advanced PD patients with sleep disturbances. MATERIALS AND METHODS: In this study, the PPX clinical trial (NCT00466167) was retrospectively analyzed for PD Sleep Scale (PDSS) total and domain scores in patients with advanced idiopathic PD receiving either PPX SR or PPX IR, who experienced motor fluctuations while on stable levodopa with a baseline PDSS total score of <90, indicating sleep disturbances. Analysis of covariance test was used to compare the adjusted mean changes at week 18 from baseline between treatment groups, after adjusting for pooled country and baseline scores. RESULTS: A total of 119 patients with PD reported sleep disturbances at baseline (PDSS <90; SR, n=59; IR, n=60). At week 18, patients receiving PPX SR reported numerically greater improvement of sleep disturbance than those receiving PPX IR, although the difference of 6.8 points was not statistically significant (adjusted mean changes in PDSS total score, SR=28.5 versus IR=21.7 points, P=0.165). Patients receiving PPX SR observed a numerically greater adjusted mean change in all PDSS domains compared with PPX IR. The overall proportions of patients with any adverse event were similar between both PPX SR and IR groups (62.7% versus 70.0%). CONCLUSION: Both the PPX formulations showed improvements in nocturnal symptoms in advanced PD patients with sleep disturbances and were generally well tolerated. Given the known pharmacokinetic profile of an SR formulation and numerical advantage in PDSS mean change over IR formulation, these preliminary evidences support future prospectively designed studies to investigate the effects of PPX SR for improved sleep. Dove Medical Press 2018-07-04 /pmc/articles/PMC6037405/ /pubmed/30013321 http://dx.doi.org/10.2147/DDDT.S160300 Text en © 2018 Xiang et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Original Research
Xiang, Wei
Sun, Ya Qing
Teoh, Hui Chin
Comparison of nocturnal symptoms in advanced Parkinson’s disease patients with sleep disturbances: pramipexole sustained release versus immediate release formulations
title Comparison of nocturnal symptoms in advanced Parkinson’s disease patients with sleep disturbances: pramipexole sustained release versus immediate release formulations
title_full Comparison of nocturnal symptoms in advanced Parkinson’s disease patients with sleep disturbances: pramipexole sustained release versus immediate release formulations
title_fullStr Comparison of nocturnal symptoms in advanced Parkinson’s disease patients with sleep disturbances: pramipexole sustained release versus immediate release formulations
title_full_unstemmed Comparison of nocturnal symptoms in advanced Parkinson’s disease patients with sleep disturbances: pramipexole sustained release versus immediate release formulations
title_short Comparison of nocturnal symptoms in advanced Parkinson’s disease patients with sleep disturbances: pramipexole sustained release versus immediate release formulations
title_sort comparison of nocturnal symptoms in advanced parkinson’s disease patients with sleep disturbances: pramipexole sustained release versus immediate release formulations
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6037405/
https://www.ncbi.nlm.nih.gov/pubmed/30013321
http://dx.doi.org/10.2147/DDDT.S160300
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