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The Parkinson-Control study: a 1-year randomized, double-blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease.
Mov Disord. 2006 Apr; 21(4):500-9.MD

Abstract

Dopamine agonists have been recommended as early treatment for Parkinson's disease (PD), alone or combined with levodopa. Piribedil is a non-ergot selective D(2)/D(3) agonist with alpha(2) antagonist properties shown to be effective in the treatment of PD. This 12-month international, randomized, double-blind trial aimed to assess the efficacy of piribedil 150 mg versus bromocriptine 25 mg, in early combination with levodopa in Stage I to III PD patients. Motor efficacy was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS III, Items 18-31) as improvement from baseline. Response rate was defined as a 30% improvement. Among the 425 randomly assigned patients, 178 were also included in a substudy on cognitive follow-up evaluated by a dysexecutive syndrome oriented battery. A relevant improvement in UPDRS III over the 12-month study duration was observed both in the piribedil and bromocriptine groups (-7.9 +/- 9.7 points from baseline versus -8.0 +/- 9.5; not significant [n.s.]) with a response rate of 58.4% and 55.3% (n.s.), respectively. Piribedil and bromocriptine resulted in similar improvement on all UPDRS III subscores. Piribedil patients required less levodopa dose increase than those on bromocriptine. Cognitive performance remained generally unchanged in both groups, with a significant effect of piribedil limited to the Wisconsin Card Sorting Test. An overall good tolerability of piribedil was observed. Early combination of piribedil 150 mg with levodopa resulted in significant long-term improvement of all motor symptoms in PD patients insufficiently controlled by levodopa alone. Taking into account both efficacy and acceptability in the long-term, piribedil proved in this bromocriptine controlled study to be an effective and safe treatment for PD.

Authors+Show Affiliations

Instituto de Ciências da Saúde, Universidade Católica Portuguesa, Lisboa, Portugal.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo 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
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16267842

Citation

Castro-Caldas, Alexandre, et al. "The Parkinson-Control Study: a 1-year Randomized, Double-blind Trial Comparing Piribedil (150 Mg/day) With Bromocriptine (25 Mg/day) in Early Combination With Levodopa in Parkinson's Disease." Movement Disorders : Official Journal of the Movement Disorder Society, vol. 21, no. 4, 2006, pp. 500-9.
Castro-Caldas A, Delwaide P, Jost W, et al. The Parkinson-Control study: a 1-year randomized, double-blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease. Mov Disord. 2006;21(4):500-9.
Castro-Caldas, A., Delwaide, P., Jost, W., Merello, M., Williams, A., Lamberti, P., Aguilar, M., Del Signore, S., & Cesaro, P. (2006). The Parkinson-Control study: a 1-year randomized, double-blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease. Movement Disorders : Official Journal of the Movement Disorder Society, 21(4), 500-9.
Castro-Caldas A, et al. The Parkinson-Control Study: a 1-year Randomized, Double-blind Trial Comparing Piribedil (150 Mg/day) With Bromocriptine (25 Mg/day) in Early Combination With Levodopa in Parkinson's Disease. Mov Disord. 2006;21(4):500-9. PubMed PMID: 16267842.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Parkinson-Control study: a 1-year randomized, double-blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease. AU - Castro-Caldas,Alexandre, AU - Delwaide,Paul, AU - Jost,Wolfgang, AU - Merello,Marcelo, AU - Williams,Adrian, AU - Lamberti,Paolo, AU - Aguilar,Miguel, AU - Del Signore,Susanna, AU - Cesaro,Pierre, AU - ,, PY - 2005/11/4/pubmed PY - 2006/9/27/medline PY - 2005/11/4/entrez SP - 500 EP - 9 JF - Movement disorders : official journal of the Movement Disorder Society JO - Mov Disord VL - 21 IS - 4 N2 - Dopamine agonists have been recommended as early treatment for Parkinson's disease (PD), alone or combined with levodopa. Piribedil is a non-ergot selective D(2)/D(3) agonist with alpha(2) antagonist properties shown to be effective in the treatment of PD. This 12-month international, randomized, double-blind trial aimed to assess the efficacy of piribedil 150 mg versus bromocriptine 25 mg, in early combination with levodopa in Stage I to III PD patients. Motor efficacy was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS III, Items 18-31) as improvement from baseline. Response rate was defined as a 30% improvement. Among the 425 randomly assigned patients, 178 were also included in a substudy on cognitive follow-up evaluated by a dysexecutive syndrome oriented battery. A relevant improvement in UPDRS III over the 12-month study duration was observed both in the piribedil and bromocriptine groups (-7.9 +/- 9.7 points from baseline versus -8.0 +/- 9.5; not significant [n.s.]) with a response rate of 58.4% and 55.3% (n.s.), respectively. Piribedil and bromocriptine resulted in similar improvement on all UPDRS III subscores. Piribedil patients required less levodopa dose increase than those on bromocriptine. Cognitive performance remained generally unchanged in both groups, with a significant effect of piribedil limited to the Wisconsin Card Sorting Test. An overall good tolerability of piribedil was observed. Early combination of piribedil 150 mg with levodopa resulted in significant long-term improvement of all motor symptoms in PD patients insufficiently controlled by levodopa alone. Taking into account both efficacy and acceptability in the long-term, piribedil proved in this bromocriptine controlled study to be an effective and safe treatment for PD. SN - 0885-3185 UR - https://www.unboundmedicine.com/medline/citation/16267842/The_Parkinson_Control_study:_a_1_year_randomized_double_blind_trial_comparing_piribedil__150_mg/day__with_bromocriptine__25_mg/day__in_early_combination_with_levodopa_in_Parkinson's_disease_ L2 - https://doi.org/10.1002/mds.20750 DB - PRIME DP - Unbound Medicine ER -