PMID- 21819487 OWN - NLM STAT- MEDLINE DCOM- 20120719 LR - 20151113 IS - 1468-1331 (Electronic) IS - 1351-5101 (Linking) VI - 19 IP - 2 DP - 2012 Feb TI - Efficacy, safety and tolerability of rasagiline as adjunctive therapy in elderly patients with Parkinson's disease. PG - 258-64 LID - 10.1111/j.1468-1331.2011.03484.x [doi] AB - BACKGROUND: Rasagiline, an MAO-B inhibitor, is indicated for the treatment of Parkinson's disease (PD). In this post hoc analysis, the efficacy, safety and tolerability of rasagiline as an adjunct to levodopa were compared with placebo in elderly (>/=70 years) and younger (<70 years) patients with PD. METHODS: Data were pooled from the Parkinson's Rasagiline: Efficacy and Safety on the Treatment of 'OFF' and Lasting effect in Adjunct therapy with Rasagiline Given Once daily randomized, double-blind, placebo-controlled trials with the primary efficacy end-point being the reduction from baseline in daily OFF time. Secondary efficacy end-points included scores for Clinical Global Improvement (CGI)-Examiner during ON time, Unified Parkinson's Disease Rating Scale (UPDRS)-ADL during OFF time, UPDRS-Motor during ON time and total daily ON time with and without troublesome dyskinesia. Tolerability was evaluated from adverse events (AEs) in the two age groups. RESULTS: Rasagiline decreased daily OFF time versus placebo (P<0.01) and improved CGI-Examiner score (P=0.001) and UPDRS-Motor ON score (P<0.05). Changes in UPDRS-ADL OFF score and total daily ON time without dyskinesia also favoured rasagiline but were not significant. Between-group comparisons (>/=70 vs. <70 years) showed that efficacy was unaffected by age for all end-points (P>0.1), and rasagiline was well tolerated amongst both groups of patients with a comparable incidence of total and dopaminergic AEs (P>0.1). CONCLUSIONS: Adjunct rasagiline is efficacious and well tolerated in elderly non-demented patients (>/=70 years) with moderate to advanced PD. Confirmation of the efficacy and safety of rasagiline in the elderly patient subgroup is especially relevant because of the increasing number of elderly patients with PD. CI - (c) 2011 The Author(s). European Journal of Neurology (c) 2011 EFNS. FAU - Tolosa, E AU - Tolosa E AD - Neurology Service, Hospital Clinic Universitari, Centro de Investigacion Biomedica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), IDIBAPS, Universitat de Barcelona, Spain. etolosa@clinic.ub.es FAU - Stern, M B AU - Stern MB LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20110805 PL - England TA - Eur J Neurol JT - European journal of neurology JID - 9506311 RN - 0 (Antiparkinson Agents) RN - 0 (Indans) RN - 0 (Monoamine Oxidase Inhibitors) RN - 0 (Neuroprotective Agents) RN - 003N66TS6T (rasagiline) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antiparkinson Agents/adverse effects/*therapeutic use MH - Double-Blind Method MH - Drug Therapy, Combination MH - Female MH - Humans MH - Indans/adverse effects/*therapeutic use MH - Male MH - Middle Aged MH - Monoamine Oxidase Inhibitors/adverse effects/*therapeutic use MH - Neuroprotective Agents/adverse effects/*therapeutic use MH - Parkinson Disease/*drug therapy MH - Treatment Outcome EDAT- 2011/08/09 06:00 MHDA- 2012/07/20 06:00 CRDT- 2011/08/09 06:00 PHST- 2011/08/09 06:00 [entrez] PHST- 2011/08/09 06:00 [pubmed] PHST- 2012/07/20 06:00 [medline] AID - 10.1111/j.1468-1331.2011.03484.x [doi] PST - ppublish SO - Eur J Neurol. 2012 Feb;19(2):258-64. doi: 10.1111/j.1468-1331.2011.03484.x. Epub 2011 Aug 5.