| 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. |
| Authors | J Carsten Möller, Wolfgang H Oertel, Jürgen Köster, Gianni Pezzoli, Leandro Provinciali
(Affiliation: Department of Neurology, Philipps-University Marburg, Germany.)
|
| Journal | Movement disorders : official journal of the Movement Disorder Society
(Mov Disord)
Vol. 20
Issue 5
Pg. 602-10
(May 2005)
ISSN: 0885-3185 United States |
| PMID | 15726540
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
|
| Copyright | Copyright 2005 Movement Disorder Society. |
| Chemical References |
- Antiparkinson Agents
- Benzothiazoles
- Thiazoles
- pramipexol
|
| Topics |
- Aged
- Antiparkinson Agents
(adverse effects, therapeutic use)
- Benzothiazoles
- Demography
- Depression
(epidemiology)
- Disorders of Excessive Somnolence
(epidemiology)
- Double-Blind Method
- Drug Administration Schedule
- Female
- Humans
- Male
- Parkinson Disease
(drug therapy, epidemiology)
- Severity of Illness Index
- Thiazoles
(adverse effects, therapeutic use)
- Tremor
(epidemiology)
|
