Journal of Neural Transmission

, Volume 109, Issue 4, pp 489-501

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

  • E. R. BruntAffiliated withDepartment of Neurology, University Hospital, Groningen, The Netherlands
  • , D. J. BrooksAffiliated withDivision of Neuroscience, Imperial College School of Medicine, Hammersmith Hospital, London, United Kingdom
  • , A. D. KorczynAffiliated withSieratzki Chair of Neurology, Sackler Faculty of Medicine, Tel-Aviv University, Israel
  • , J.-L. MontastrucAffiliated withDepartment of Clinical Pharmacology, Faculty of Medicine, Toulouse, France
  • , F. StocchiAffiliated withDepartment of Neuroscience and "Neuromed", University "la Sapienza", Rome, Italy
  • , on behalf of the 043 Study Group

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Summary.

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 fluc-tuations, 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.

Keywords: Parkinson's disease ropinirole bromocriptine drug therapy.