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Early piribedil monotherapy of Parkinson's disease: A planned seven‐month report of the REGAIN study
Author(s) -
Rascol Olivier,
Dubois Bruno,
Caldas Alexandre Castro,
Senn Stephen,
Del Signore Susanna,
Lees Andrew
Publication year - 2006
Publication title -
movement disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.352
H-Index - 198
eISSN - 1531-8257
pISSN - 0885-3185
DOI - 10.1002/mds.21122
Subject(s) - placebo , medicine , rating scale , parkinson's disease , gastroenterology , anesthesia , disease , psychology , developmental psychology , alternative medicine , pathology
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 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. © 2006 Movement Disorder Society