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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.
J Neural Transm (Vienna). 2002 Apr; 109(4):489-502.JN

Abstract

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.

Authors+Show Affiliations

Department of Neurology, University Hospital, Groningen, The Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

11956968

Citation

Brunt, E R., et al. "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." Journal of Neural Transmission (Vienna, Austria : 1996), vol. 109, no. 4, 2002, pp. 489-502.
Brunt ER, Brooks DJ, Korczyn AD, et al. 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. J Neural Transm (Vienna). 2002;109(4):489-502.
Brunt, E. R., Brooks, D. J., Korczyn, A. D., Montastruc, J. L., & Stocchi, F. (2002). 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. Journal of Neural Transmission (Vienna, Austria : 1996), 109(4), 489-502.
Brunt ER, et al. 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. J Neural Transm (Vienna). 2002;109(4):489-502. PubMed PMID: 11956968.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Brunt,E R, AU - Brooks,D J, AU - Korczyn,A D, AU - Montastruc,J-L, AU - Stocchi,F, AU - ,, PY - 2002/4/17/pubmed PY - 2002/6/26/medline PY - 2002/4/17/entrez SP - 489 EP - 502 JF - Journal of neural transmission (Vienna, Austria : 1996) JO - J Neural Transm (Vienna) VL - 109 IS - 4 N2 - 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. SN - 0300-9564 UR - https://www.unboundmedicine.com/medline/citation/11956968/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_ L2 - https://doi.org/10.1007/s007020200040 DB - PRIME DP - Unbound Medicine ER -