Rotigotine Transdermal System Improves Neuropsychiatric Features (Apathy, Anhedonia, Anxiety, and Depression) and Fatigue in Patients with Parkinson's Disease: A Post-Hoc Analysis of Five Double-Blind Placebo-Controlled Studies (P06.088)

Abstract

Objective: To investigate the effect of rotigotine on neuropsychiatric features and fatigue in patients with Parkinson9s disease (PD). Background Neuropsychiatric features (including apathy, anhedonia, anxiety, and depression) and fatigue are frequently reported for patients with PD and are key determinants of health-related quality of life. Design/Methods: Post-hoc analysis of 5 placebo-controlled studies of rotigotine in patients with early-PD (SP512, SP513), advanced-PD (SP650 [PREFER], SP515 [CLEOPATRA-PD, NCT00244387]), and PD with unsatisfactory control of early-morning motor symptoms (SP889 [RECOVER, NCT00474058]). Individual items assessing apathy, anhedonia, anxiety, anxiety/depression, depression, and fatigue were identified from scales used in these studies (NMSS, BDI-II, PDQ-39, EQ-5D, and PDQ-8). As a post-hoc analysis, all p-values are exploratory. Results: Improvements were observed with rotigotine versus placebo in items assessing feelings of depression (a total of 3 items were assessed: CLEOPATRA-PD [1 item] and RECOVER [2 items]; least square [LS] mean treatment differences p Conclusions: This exploratory post-hoc analysis suggests that neuropsychiatric features (including apathy, anhedonia, anxiety, and depression) and fatigue in PD may be improved with transdermal rotigotine. The effect of rotigotine on these prevalent non-motor symptoms warrants further investigation in prospective studies. Supported by: UCB Pharma. Disclosure: Dr. Hauser has received personal compensation for activities with Boehringer Ingelheim Pharmaceuticals, Inc., Teva Neuroscience, Impax Pharmaceuticals, UCB, Inc., GE Healthcare, Ipsen, Novartis, Parkinson Study Group, Solvay S.A., Quintiles, Biogen Idec, Bial, Lundbeck Research USA, Inc., Chelsea Therapeutics, Impax, Santhera Pharmaceuticals, Serono, Synosia Therapeutics, Schering-Plough Corporation, Shire Pharmaceuticals Group, XenoPort, Inc., Medivation, Inc., Addex, Adamas Pharmaceuticals, and Noven Pharmaceuticals as a speaker, consultant and/or member of an advisory board.Dr. Hauser has received research support from PICO-Tesla, Schwartz Biosciences, Genzyme Corporation, Acadia, Solvay S.A., Impax, TEVA Neuroscience, Serono, Schering-Plough Corporation, Novartis, Ipsen, XenoPort Pharmaceuticals, Chelsea Therapeutics, Allergan, Inc., Molecular Biometrics, The Michael J. Fox Foundation for Parkinson9s Research, and the National Parkinson Foundation. Dr. Nausieda has nothing to disclose. Dr. Surmann has received personal compensation for activities with UCB Pharma. Dr. Moran has received personal compensation for activities with UCB Pharma as an employee. Dr. Moran holds stock and/or stock options in UCB Pharma. Dr. Barone has received personal compensation for activities with Boehringer Ingelheim Pharmaceuticals, Inc., Eisai Inc., GE Healthcare, Merck Serono, Novartis, UCB Pharma, and Lundbeck Research USA, Inc as a speaker and/or participant on an advisory board. Dr. Barone has received research support from Boehringer Ingelheim Pharmaceuticals, Inc., Merck Serono, Novartis, UCB Pharma, Lundbeck Research USA, Inc., and Solvay S.A.