Journal
MOVEMENT DISORDERS
Volume 25, Issue 14, Pages 2326-2332Publisher
WILEY
DOI: 10.1002/mds.23262
Keywords
pramipexole-extended release; Parkinson's disease; dopamine agonist; switch trial
Categories
Funding
- Boehringer Ingelheim
- Curry Rockefeller Group, Tarrytown, NY
- Eisai
- GlaxoSmithKline
- Lundbeck
- Novartis
- Schering
- Solvay
- Teva Neuroscience
- UCB
- Merck-Serono
- Schwarz Pharma/UCB
- Allergan Neuroscience
- Embryon
- Genzyme
- Impax
- Ipsen Pharmaceuticals (formerly Vernalis)
- Kyowa Pharmaceutical
- Merck
- Quintiles
- Santhera
- Schering Plough
- Orion
- Teva
- Teva-Lundbeck
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The aim of this article is to test the feasibility, in early Parkinson's disease (PD), of an overnight switch from immediate-release (IR) pramipexole to a new once-daily extended-release (ER) formulation. Nonfluctuating patients on pramipexole IR three-times daily, alone or with levodopa, for early PD were randomly switched overnight to double-blind IR three-times daily (N = 52) or ER once-daily (N = 104) at initially unchanged daily dosage. Successful switching (defined as no worsening >15% of baseline UPDRS II+III score and no drug-related adverse event withdrawal) was assessed at 9 weeks, after optional dosage adjustments (primary endpoint), and at 4 weeks, before adjustment. Other secondary endpoints included adjusted mean changes from baseline in UPDRS scores and proportion of responders based on Clinical or Patient Global Impression (CGI/PGI). Absolute difference between percentage of successful switch to ER versus IR was tested for ER noninferiority, defined as a 95% confidence-interval lower bound not exceeding -15%. At 9 weeks, 84.5% of the ER group had been successfully switched, versus 94.2% for IR. Noninferiority was not demonstrated, with a difference of -9.76% (95% CI: [-18.81%, +1.66%]). At 4 weeks, 81.6% of the ER group had been successfully switched, versus 92.3% for IR, a difference of -10.75% (95% CI: [-20.51%, +1.48%]). UPDRS changes and CGI/PGI analyses showed no differences between the groups. Both formulations were safe and well tolerated. Pramipexole ER was not equivalent to IR, but the difference was marginal. The fact that >80% of the patients successfully switched overnight at unchanged dosage shows that this practice was feasible in most patients. (C) 2010 Movement Disorder Society
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