Long-term efficacy and safety of pramipexole in advanced Parkinson's disease: results from a European multicenter trial.

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.
AuthorsJ Carsten Möller, Wolfgang H Oertel, Jürgen Köster, Gianni Pezzoli, Leandro Provinciali
JournalMovement disorders : official journal of the Movement Disorder Society (Mov Disord) Vol. 20 Issue 5 Pg. 602-10 (May 2005) ISSN: 0885-3185 [Print] United States
PMID15726540 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
CopyrightCopyright 2005 Movement Disorder Society.
Chemical References
  • Antiparkinson Agents
  • Benzothiazoles
  • Thiazoles
  • pramipexole
  • 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)

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