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Role and clinical utility of pramipexole extended release in the treatment of early Parkinson’s disease

机译:普拉克索缓释剂在帕金森氏病早期治疗中的作用和临床用途

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摘要

The aim of this article is to provide a short review of the most relevant pharmacological and clinical data on pramipexole extended release (ER) as well as to address the clinical utility and potential advantages of a once-daily formulation especially in the treatment of early Parkinson’s disease (PD). Pramipexole is widely established as a symptomatic treatment in early as well as advanced PD. The development of an ER formulation, with stable pramipexole plasma concentration over 24 hours, now offers a bioequivalent once-daily alternative. Double-blind randomized controlled trials in early and advanced PD, have established noninferiority of pramipexole ER compared with immediate release as well as superiority of both formulations over placebo. The overnight switch from the standard to the once-daily formulation was shown to be successful in >80% of patients without requiring any dose adjustments. Potential benefits of the prolonged-release design, which have not yet been formally demonstrated in the pivotal trial program, include improved compliance and a potential for better symptomatic control, particularly in patients with early disease that can be managed with monotherapy.
机译:本文的目的是简要回顾普拉克索缓释(ER)的最相关药理和临床数据,并探讨每日一次制剂的临床实用性和潜在优势,尤其是在早期帕金森氏病的治疗中疾病(PD)。普拉克索已被广泛确立为早期和晚期PD的对症治疗。具有24小时稳定的普拉克索血浆浓度的ER制剂的开发现在提供了生物等效的每日一次替代品。在早期和晚期PD中进行的双盲随机对照试验已经证实,普拉克索ER与立即释放相比,其非劣效性以及两种制剂均优于安慰剂。从标准品转换为每日一次制剂的过夜转换在> 80%的患者中无需任何剂量调整即可成功。延长释放设计的潜在好处(尚未在关键试验计划中正式证明)包括改善依从性和更好的症状控制潜力,尤其是对于可以通过单药治疗的早期疾病患者。

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