ParkinsonFranceV1, Main, Exploration, bibRecord, 000932

Long-term safety and sustained efficacy of extended-release pramipexole in early and advanced Parkinson's disease

Identifieur interne : 000932 ( Main/Exploration ); précédent : 000931; suivant : 000933

Long-term safety and sustained efficacy of extended-release pramipexole in early and advanced Parkinson's disease

Auteurs : R A Hauser [États-Unis] ; A H V. Schapira [Royaume-Uni] ; P. Barone [Italie] ; Y. Mizuno [Japon] ; O. Rascol [France] ; M. Busse [Allemagne] ; C. Debieuvre [France] ; M. Fraessdorf [Allemagne] ; Werner Poewe [Autriche]

Source :

European Journal of Neurology [ 1351-5101 ] ; 2014.

RBID : PMC:4282380

Abstract

Background and purpose

To assess the long-term safety and efficacy of pramipexole as a once-daily (q.d.) extended-release oral formulation in early or advanced Parkinson's disease (PD).

Methods

In two double-blind (DB) studies of early PD and one of advanced PD, active-treatment arms received pramipexole immediate release (IR) or extended release (ER), with exposure lasting up to 33 weeks. In open-label (OL) extensions that followed immediately, subjects took ER q.d. for up to 80 weeks, with dosage adjustment permitted (range 0.375–4.5 mg q.d.).

Results

Of 590 subjects completing an early-PD DB study, 511 entered the early-PD OL extension; 408 completed it. Reported adverse events (AEs) with incidence ≥10.0% were somnolence (15.1%), peripheral edema (11.7%) and back pain (10.6%). Of 465 subjects completing the advanced-PD DB study, 391 entered the advanced-PD OL extension; 329 completed it. Reported AEs with incidence ≥10.0% were dyskinesia (27.4%) and somnolence (13.6%). Impulse control disorders were identified by semi-structured interview in 13 subjects (1.4% of 902). In exploratory analyses, adjusted mean Unified Parkinson's Disease Rating Scale (UPDRS) Parts II + III scores (excluding ex-placebo recipients) remained substantially improved from DB baseline scores prior to pramipexole introduction, at −6.6 and −6.3 points amongst ex-DB-ER and ex-DB-IR recipients after 113 weeks of pramipexole (33 DB plus 80 OL) in early PD, and −11.5 and −9.1 after up to 113 weeks (up to 33 DB plus 80 OL) in advanced PD.

Conclusions

These results support the long-term safety and efficacy of pramipexole ER in early and advanced PD. AEs were typical for dopaminergic medications, and UPDRS scores suggested sustained symptomatic benefit.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4282380

DOI: 10.1111/ene.12375
PubMed: 24834511
PubMed Central: 4282380

Affiliations:

Le document en format XML

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<front><div type="abstract" xml:lang="en"><sec><title>Background and purpose</title>
<p>To assess the long-term safety and efficacy of pramipexole as a once-daily (q.d.) extended-release oral formulation in early or advanced Parkinson's disease (PD).</p>
</sec>
<sec><title>Methods</title>
<p>In two double-blind (DB) studies of early PD and one of advanced PD, active-treatment arms received pramipexole immediate release (IR) or extended release (ER), with exposure lasting up to 33 weeks. In open-label (OL) extensions that followed immediately, subjects took ER q.d. for up to 80 weeks, with dosage adjustment permitted (range 0.375–4.5 mg q.d.).</p>
</sec>
<sec><title>Results</title>
<p>Of 590 subjects completing an early-PD DB study, 511 entered the early-PD OL extension; 408 completed it. Reported adverse events (AEs) with incidence ≥10.0% were somnolence (15.1%), peripheral edema (11.7%) and back pain (10.6%). Of 465 subjects completing the advanced-PD DB study, 391 entered the advanced-PD OL extension; 329 completed it. Reported AEs with incidence ≥10.0% were dyskinesia (27.4%) and somnolence (13.6%). Impulse control disorders were identified by semi-structured interview in 13 subjects (1.4% of 902). In exploratory analyses, adjusted mean Unified Parkinson's Disease Rating Scale (UPDRS) Parts II + III scores (excluding ex-placebo recipients) remained substantially improved from DB baseline scores prior to pramipexole introduction, at −6.6 and −6.3 points amongst ex-DB-ER and ex-DB-IR recipients after 113 weeks of pramipexole (33 DB plus 80 OL) in early PD, and −11.5 and −9.1 after up to 113 weeks (up to 33 DB plus 80 OL) in advanced PD.</p>
</sec>
<sec><title>Conclusions</title>
<p>These results support the long-term safety and efficacy of pramipexole ER in early and advanced PD. AEs were typical for dopaminergic medications, and UPDRS scores suggested sustained symptomatic benefit.</p>
</sec>
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La maladie de Parkinson en France (serveur d'exploration)

Long-term safety and sustained efficacy of extended-release pramipexole in early and advanced Parkinson's disease

Long-term safety and sustained efficacy of extended-release pramipexole in early and advanced Parkinson's disease

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Abstract

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	La maladie de Parkinson en France (serveur d'exploration)
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