Long‐term efficacy and safety of pramipexole in advanced Parkinson's disease: Results from a European multicenter trial
Identifieur interne : 001469 ( Main/Exploration ); précédent : 001468; suivant : 001470Long‐term efficacy and safety of pramipexole in advanced Parkinson's disease: Results from a European multicenter trial
Auteurs : J. Carsten Möller [Allemagne] ; Wolfgang H. Oertel [Allemagne] ; Jürgen Köster [Allemagne] ; Gianni Pezzoli [Italie] ; Leandro Provinciali [Italie]Source :
- Movement Disorders [ 0885-3185 ] ; 2005-05.
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Abstract
A double‐blind, placebo‐controlled study with a subsequent open‐label phase was conducted in 354 patients with Parkinson's disease (PD) and motor fluctuations under individually adjusted therapy with levodopa. During the double‐blind phase 174 patients received pramipexole and 180 placebo. In agreement with previous studies, pramipexole treatment improved UPDRS sum scores of parts II and III by 30% and off times by approximately 2.5 hours per day. Differences between the treatment groups became significant at a daily dose of 0.75 mg of pramipexole dihydrochloride. We, furthermore, performed post hoc analyses with respect to resting tremor and depression. Patients with pronounced resting tremor derived a clear benefit from pramipexole treatment compared with placebo. In addition, pramipexole significantly improved the subitems motivation/initiative and depression in a subpopulation with increased Unified Parkinson's Disease Rating Scale I scores at the time of inclusion. There were 262 patients who were subsequently enrolled into the open‐label study featuring a maximum duration of up to 57 months. Statistical analysis revealed good long‐term efficacy and tolerability of pramipexole. Overall, only a low prevalence of somnolence was found. In summary, this study provides additional level I evidence of the usefulness of pramipexole, suggests a particular tremorlytic and a possible antidepressant action of this compound, and addresses for the first time its efficacy and safety during long‐term administration in advanced PD. © 2005 Movement Disorder Society
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DOI: 10.1002/mds.20397
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