title: Rasagiline improves quality of life in patients with early Parkinson's disease.
abstract: The objective of this study was to determine the effects of rasagiline as monotherapy on quality of life (QOL) in patients with early Parkinson's disease (PD). Rasagiline, a potent, second-generation, irreversible, selective monoamine oxidase B inhibitor improves PD symptoms in patients with early PD. Patients with early untreated PD were randomly assigned to once-daily rasagiline 1 mg/day, rasagiline 2 mg/day, or placebo in a 6-month, double-blind trial (n=404). At the end of 6 months, patients entered the preplanned, active-treatment phase in which those receiving 1 mg/day and 2 mg/day of rasagiline continued on their previously assigned dosages and those receiving placebo switched to rasagiline 2 mg/day, while maintaining blinding to treatment assignments. QOL was measured with the Parkinson's Disease Quality of Life questionnaire (PDQUALIF) at 0, 14, 26, and 52 weeks after randomization. Analysis of the change in PDQUALIF scores from baseline to 6 months showed adjusted treatment effects (with 95% confidence interval) favoring rasagiline over placebo of -2.91 units (-5.19, -0.64, P=0.01) for the 1 mg/day group and -2.74 units (-5.02, -0.45, P=0.02) for the 2 mg/day. Subscore analysis attributed most of this benefit to the self-image/sexuality domain. At 12 months (n=266), with all groups receiving rasagiline for at least 6 months, no significant differences in PDQUALIF scores were seen between groups. Rasagiline improved QOL compared with placebo. This QOL improvement appears to be accounted for primarily by the symptomatic benefit of rasagiline.
authors.affiliation: Department of Neurology, Johns Hopkins University, Baltimore, Maryland 21287, USA. kbiglan1@jhmi.edu
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Biglan
authors.forename: Steven
authors.initials: S
authors.lastname: Schwid
authors.forename: Shirley
authors.initials: S
authors.lastname: Eberly
authors.forename: Karen
authors.initials: K
authors.lastname: Blindauer
authors.forename: Stanley
authors.initials: S
authors.lastname: Fahn
authors.forename: Tamar
authors.initials: T
authors.lastname: Goren
authors.forename: Karl
authors.initials: K
authors.lastname: Kieburtz
authors.forename: David
authors.initials: D
authors.lastname: Oakes
authors.forename: Sandra
authors.initials: S
authors.lastname: Plumb
authors.forename: Andrew
authors.initials: A
authors.lastname: Siderowf
authors.forename: Matthew
authors.initials: M
authors.lastname: Stern
authors.forename: Ira
authors.initials: I
authors.lastname: Shoulson
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007189:Indans / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D009483:Neuropsychological Tests; D010300:Parkinson Disease / Q000188:drug therapy* / Q000523:psychology*; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007189:Indans; D018696:Neuroprotective Agents; C031967:rasagiline