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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 Grp,; (2006) Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study. MOVEMENT DISORD , 21 (12) 2110 - 2115. 10.1002/mds.21122.

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Abstract

Piribedil is a D-2 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 earl 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% Cl = 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. (C) 2006 Movement Disorder Society.

Type:Article
Title:Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study
DOI:10.1002/mds.21122
Keywords:piribedil, L-dopa, Parkinson's disease, monotherapy, RAT IN-VIVO, SELECTIVE ANTAGONIST, RECEPTOR ACTIVATION, EARLY COMBINATION, DOPAMINE D-3, LEVODOPA, ROPINIROLE, TRIAL, BROMOCRIPTINE, STIMULATION
UCL classification:UCL > School of Life and Medical Sciences > Faculty of Brain Sciences > Institute of Neurology > RLW Institute of Neurological Sciences
UCL > School of BEAMS > Faculty of Maths and Physical Sciences > Statistical Science

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