Article

Extended-release pramipexole in advanced Parkinson disease: a randomized controlled trial.

Institute of Neurology, University College London, London, UK.
Neurology (impact factor: 8.31). 08/2011; 77(8):767-74. DOI:10.1212/WNL.0b013e31822affdb pp.767-74
Source: PubMed

ABSTRACT In advanced Parkinson disease (PD), immediate-release pramipexole, taken 3 times daily, improves symptoms and quality of life. A once-daily extended-release formulation may be an effective and simple alternative therapy.
For a multicenter randomized, double-blind, parallel trial of extended- and immediate-release pramipexole vs placebo, patients experiencing motor fluctuations while taking levodopa underwent flexible study drug titration and then maintenance at optimized dosage (0.375-4.5 mg/day). The primary endpoint was a change in the Unified Parkinson's Disease Rating Scale (UPDRS) part II+III score at 18 weeks, with further assessments at 33 weeks in a subset of patients. Adverse events were recorded throughout.
Among 507 patients in the 18-week analyses, UPDRS II+III scores decreased (from baseline means of 40.0-41.7) by an adjusted mean of -11.0 for extended-release pramipexole and -12.8 for immediate-release pramipexole vs -6.1 for placebo (p = 0.0001 and p < 0.0001) and off-time decreased (from baseline means of 5.8-6.0 hours/day) by an adjusted mean of -2.1 and -2.5 vs -1.4 hours/day (p = 0.0199 and p < 0.0001). Other outcomes were largely corroborative, including a significant improvement in early morning off symptoms. Among 249 pramipexole patients completing 33 weeks, UPDRS II+III and off-time findings showed ≤10.1% change from 18-week values. Both formulations were well-tolerated.
Extended-release pramipexole significantly improved UPDRS score and off-time compared with placebo, with similar efficacy, tolerability, and safety of immediate-release pramipexole compared with placebo.
This study provides Class I evidence that the extended-release form of pramipexole, taken once daily, is efficacious as an adjunct to levodopa in advanced PD.

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    Eva-Maria Hametner, Klaus Seppi, Werner Poewe
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Data provided are for informational purposes only. Although carefully collected, accuracy cannot be guaranteed. The impact factor represents a rough estimation of the journal's impact factor and does not reflect the actual current impact factor. Publisher conditions are provided by RoMEO. Differing provisions from the publisher's actual policy or licence agreement may be applicable.

Keywords

18-week analyses
 
18-week values
 
249 pramipexole patients
 
3 times
 
Adverse events
 
Extended-release pramipexole
 
flexible study drug titration
 
formulations
 
immediate-release pramipexole
 
motor fluctuations
 
multicenter randomized
 
once-daily extended-release formulation
 
optimized dosage
 
parallel trial
 
Parkinson disease
 
primary endpoint
 
simple alternative therapy
 
Unified Parkinson's Disease Rating Scale
 
UPDRS II+III
 
UPDRS II+III scores