A six-month multicentre, double-blind, bromocriptine-controlled study of the safety and efficacy of ropinirole in the treatment of patients with Parkinson's disease not optimally controlled by L-dopa

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DOI

  • E. R. Brunt, Universitair Medisch Centrum Groningen
  • ,
  • D. J. Brooks
  • A. D. Korczyn, Tel Aviv University Medical School
  • ,
  • J. L. Montastruc, Faculté de Médecine
  • ,
  • F. Stocchi, Sapienza University of Rome

Objectives. To compare the safety and efficacy of ropinirole and bromocriptine as adjunct therapy in patients with Parkinson's disease (PD) not optimally controlled by L-dopa. Methods. A randomised, double-blind trial in which 555 patients were assigned to three treatment groups according to the level of daily dosage of L-dopa, presence of motor fluctuations, and use of dopamine agonist before study entry. Patient response was defined as at least a 20% reduction in daily L-dopa dose plus: for patients with no prior treatment and no motor fluctuations, a 20% reduction in UPDRS motor score; for patients with motor fluctuations, a 20% reduction in time spent "off"; and for patients already taking an agonist, an improvement on the CGI scale. Results. Safety assessments showed no significant differences in the two treatment groups for patients without prior dopamine-agonist therapy. In the group of patients with prior dopamine-agonist therapy, more patients reported adverse events in the ropinirole group (90% versus 79%,p < 0.001). The proportions of responders tended to be higher in ropinirole groups compared with bromocriptine groups and, in the subgroup with motor fluctuations, this difference was statistically significant (9.1% versus 0.0%, respectively; p < 0.05). Conclusions. Both drugs were well tolerated. In patients receiving a relatively high dose of L-dopa and requiring the addition of a dopamine agonist to control motor fluctuations or dyskinesias, ropinirole was significantly more effective than bromocriptine.

Original languageEnglish
JournalJournal of Neural Transmission
Volume109
Issue4
Pages (from-to)489-502
Number of pages14
ISSN0300-9564
DOIs
Publication statusPublished - 16 Apr 2002
Externally publishedYes

    Research areas

  • Bromocriptine, Drug therapy, Parkinson's disease, Ropinirole

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