Publication
Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study.
| dc.contributor.author | Rascol, O. | |
| dc.contributor.author | Dubois, B. | |
| dc.contributor.author | Caldas, A.C. | |
| dc.contributor.author | Senn, S. | |
| dc.contributor.author | Del Signore, S. | |
| dc.contributor.author | Lees, A. | |
| dc.contributor.author | Parkinson, REGAIN Study Group | |
| dc.date.accessioned | 2010-08-18T13:56:03Z | |
| dc.date.available | 2010-08-18T13:56:03Z | |
| dc.date.issued | 2006-12 | |
| dc.description.abstract | Mov Disord. 2006 Dec;21(12):2110-5. Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study. Rascol O, Dubois B, Caldas AC, Senn S, Del Signore S, Lees A; Parkinson REGAIN Study Group. INSERM U455, Clinical Investigation Center and Departments of Clinical Pharmacology and Neurosciences, Faculté de Médecine, Toulouse, France. rascol@cict.fr Abstract Piribedil is a D2 dopamine agonist, which has been shown to improve symptoms of Parkinson's disease (PD) when combined with L-dopa. The objective of this study was to compare the efficacy of piribedil monotherapy to placebo in patients with early PD over a 7-month period. Four hundred and five early PD patients were randomized (double-blind) to piribedil (150-300 mg/day) or placebo. L-dopa open-label supplementation was permitted. Unified Parkinson Disease Rating Scale part III (UPDRS III) score as the last observation on monotherapy over 7 months was the primary outcome measure. Secondary outcomes were proportion of responders (UPDRS III improvement > 30%), patients remaining on monotherapy after 7 months, UPDRS III subscores, and UPDRS II. UPDRS III improved on piribedil (-4.9 points) versus a worsening on placebo (2.6 points; estimated effect = 7.26 points; 95% CI = 5.38-9.14; P < 0.0001). The proportion of responders was significantly higher for piribedil (42%) than for placebo (14%) (OR = 4.69; 95% CI = 2.82-7.80; P < 0.001). Piribedil significantly improved several UPDRS III subscores. UPDRS II improved on piribedil by -1.2 points, while it deteriorated by 1.5 points on placebo (estimated effect = 2.71; 95% CI = 1.8-3.62; P < 0.0001). The proportion of patients remaining on monotherapy after 7 months was greater in the piribedil group (OR = 3.72; 95% CI = 2.26-6.11; P < 0.001). Safety was consistent with that reported for other dopamine agonists, gastrointestinal side effects being the most common (22% of patients in piribedil group vs. 14% on placebo). Piribedil is effective and safe as early PD therapy. PMID: 17013922 [PubMed - indexed for MEDLINE Mov Disord. 2006 Dec;21(12):2110-5. | por |
| dc.identifier.issn | 0885-3185 | |
| dc.identifier.uri | http://hdl.handle.net/10400.16/428 | |
| dc.language.iso | eng | por |
| dc.publisher | Wiley-Blackwell | por |
| dc.relation.publisherversion | http://onlinelibrary.wiley.com | por |
| dc.title | Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study. | por |
| dc.type | journal article | |
| dspace.entity.type | Publication | |
| oaire.citation.conferencePlace | New York | por |
| oaire.citation.issue | 21 | por |
| oaire.citation.title | Movement Disorders | por |
| rcaap.rights | openAccess | por |
| rcaap.type | article | por |