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

Abstract

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.

Keywords:

• pramipexole
• Parkinson’s disease
• extended release
• compliance
• control

Disclosure

Klaus Seppi has received honoraria for speaking and/or consulting from: Novartis, AstraZeneca, Boehringer Ingelheim, Lundbeck, Schwarz Pharma, UCB Pharma, Teva, and GlaxoSmithKline, and grants/research funding from: The Movement Disorders Society, Michael J Fox Foundation for Parkinson’s Research, Österreichische Nationalbank, Austrian Science Fund, and Medical University Innsbruck. Werner Poewe has received consultancy and lecture fees from: AstraZeneca, Teva, Novartis, GlaxoSmithKline, Boehringer-Ingelheim, UCB, Orion Pharma, and Merck Serono in relation to clinical drug development programs for PD, and grants/research funding from: The Movement Disorders Society, Michael J Fox Foundation for Parkinson’s Research, Österreichische Nationalbank, Austrian Science Fund, and Medical University Innsbruck. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in, or financial conflict with, the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.