Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study.

Rascol, O.; Dubois, B.; Caldas, A.C.; Senn, S.; Del Signore, S.; Lees, A.; Parkinson, REGAIN Study Group

http://hdl.handle.net/10400.16/428

Use this identifier to reference this record.

Name:	Description:	Size:	Format:
doc.4.pdf		129.7 KB	Adobe PDF	Download

Send Feedback

Authors

Parkinson, REGAIN Study Group

Abstract(s)

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.