title: Long-term outcome of early versus delayed rasagiline treatment in early Parkinson's disease.
abstract: The purpose of this study to compare the long-term clinical outcome of early versus delayed rasagiline treatment in early Parkinson's disease (PD). Subjects (N = 404) were randomly assigned to initial treatment with rasagiline (early-start group) or placebo for 6 months followed by rasagiline (delayed-start group) in the TEMPO study. Subjects who chose to participate in an open-label extension (N = 306) continued to receive rasagiline as well as other PD medications as needed. Average (+/-SD) duration in the study was 3.6 +/- 2.1 years; 177 subjects received rasagiline for > or =5.0 years. Over the entire 6.5-year follow-up period, the adjusted mean difference in change from baseline in total UPDRS scores was 2.5 units (SE 1.1; P = 0.021) or 16% (SE 5.7; P = 0.006) in favor of the early-start versus delayed-start rasagiline group. Although the interaction between treatment and time was significant, values for the early-start group were better than the delayed-start group across all time points. Significantly less worsening (percent change) in total UPDRS scores was observed in the early-start group at the time points 0.5, 1.5, 2.0, 3.0, 4.5, 5.0, and 5.5 years (P < 0.05). Compared to delayed start, early initiation of rasagiline provided long-term clinical benefit, even in the face of treatment with other dopaminergic agents. This might reflect enduring benefits due to neuroprotection or effects on compensatory mechanisms in early PD.
authors.affiliation: Parkinsons's Disease and Movement Disorders Center, University of South Florida, 5 Tampa General Circle, Tampa, FL 33606, USA. rhauser@health.usf.edu
authors.forename: Robert A
authors.initials: RA
authors.lastname: Hauser
authors.forename: Mark F
authors.initials: MF
authors.lastname: Lew
authors.forename: Howard I
authors.initials: HI
authors.lastname: Hurtig
authors.forename: William G
authors.initials: WG
authors.lastname: Ondo
authors.forename: Joanne
authors.initials: J
authors.lastname: Wojcieszek
authors.forename: Cheryl J
authors.initials: CJ
authors.lastname: Fitzer-Attas
mesh_terms: D000328:Adult; D000368:Aged; D000978:Antiparkinson Agents / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007189:Indans / Q000008:administration & dosage*; D007980:Levodopa / Q000627:therapeutic use; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D008996:Monoamine Oxidase Inhibitors / Q000008:administration & dosage*; D010300:Parkinson Disease / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D011788:Quality of Life; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000978:Antiparkinson Agents; D007189:Indans; D008996:Monoamine Oxidase Inhibitors; C031967:rasagiline; D007980:Levodopa