title: Treatment of patients with early and advanced Parkinson's disease with rotigotine transdermal system: age-relationship to safety and tolerability.
abstract: Although dopamine agonists (DAs) are sometimes perceived as poorly tolerated by the elderly, there is little clinical evidence to support these concerns. Safety and tolerability of rotigotine have been demonstrated in four 6-month randomized placebo-controlled studies: two in early Parkinson's disease (PD) and two in advanced PD. A post hoc analysis of data from these pivotal trials was carried out to compare the adverse event (AE) profiles of younger and older patient populations. Data from early and advanced PD trials were separately pooled and evaluated using two age cut-offs (<65 vs. ≥ 65 years; <75 vs. ≥ 75 years). For most AEs, no age-related differences in incidence were observed. In the early PD pool, nausea (38% vs. 30%) and headache (15% vs. 9%) were more frequent in younger (<65 years) compared with older (≥ 65 years) patients using the 65-year age cut-off. Using the 75-year cut-off, nausea (36% vs. 21%) was more frequent in younger patients (<75 years) and dizziness (15% vs. 28%) was more frequent in older patients (≥ 75 years). In the advanced PD pool, nausea was more frequent in younger patients using the 65-year age cut-off (24% vs. 19%) and falls were more frequent in older patients using the 75-year age cut-off (8% vs. 13%). In this relatively healthy population which included only few patients aged 75 years or older, rotigotine was generally well tolerated regardless of age. Data from more representative PD populations are required to fully assess potential risks of DA therapy in elderly patients.
authors.affiliation: Department of Neurology, Philipps-Universität, Baldingerstrasse, D 35043 Marburg, Germany. oertel@med.uni-marburg.de
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Oertel
authors.forename: Peter
authors.initials: P
authors.lastname: LeWitt
authors.forename: Nir
authors.initials: N
authors.lastname: Giladi
authors.forename: Liesbet
authors.initials: L
authors.lastname: Ghys
authors.forename: Frank
authors.initials: F
authors.lastname: Grieger
authors.forename: Babak
authors.initials: B
authors.lastname: Boroojerdi
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000978:Antiparkinson Agents / Q000008:administration & dosage / Q000009:adverse effects*; D018491:Dopamine Agonists / Q000008:administration & dosage / Q000009:adverse effects*; D004311:Double-Blind Method; D004361:Drug Tolerance / Q000502:physiology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage / Q000009:adverse effects*; D013876:Thiophenes / Q000008:administration & dosage / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D000978:Antiparkinson Agents; D018491:Dopamine Agonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine