Long-term benefits of rivastigmine in dementia associated with Parkinson's disease: an active treatment extension study.
In patients with dementia associated with Parkinson's disease (PD), the efficacy and safety of rivastigmine, an inhibitor of acetylcholinesterase and butyrylcholinesterase, were previously demonstrated in a 24-week double-blind placebo-controlled trial. Our objective was to determine whether benefits were sustained over the long term. Following the double-blind trial, all patients were permitted to enter an active treatment extension study, during which they received rivastigmine 3-12 mg/day. Standard safety assessments were performed. Efficacy assessments included the Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog) and other measures of cognition, daily function, neuropsychiatric symptoms, and executive function. Of 433 patients who completed the double-blind trial, 334 entered and 273 completed the active treatment extension. At 48 weeks, the mean ADAS-cog score for the whole group improved by 2 points above baseline. Placebo patients switching to rivastigmine for the active treatment extension experienced a mean cognitive improvement similar to that of the original rivastigmine group during the double-blind trial. The adverse event profile was comparable to that seen in the double-blind trial. Long-term rivastigmine treatment appeared well tolerated and may provide sustained benefits in dementia associated with PD patients who remain on treatment for up to 48 weeks.
Poewe
Werner
W
Innsbruck Medical University, Innsbruck, Austria. werner.poewe@uibk.ac.at
Wolters
Erik
E
Emre
Murat
M
Onofrj
Marco
M
Hsu
Chuanchieh
C
Tekin
Sibel
S
Lane
Roger
R
D000203:Activities of Daily Living; D000368:Aged; D002800:Cholinesterase Inhibitors / Q000627:therapeutic use*; D003071:Cognition / Q000502:physiology; D003704:Dementia / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D009483:Neuropsychological Tests / Q000706:statistics & numerical data; D010300:Parkinson Disease / Q000150:complications / Q000188:drug therapy*; D048448:Phenylcarbamates / Q000627:therapeutic use*; D000068836:Rivastigmine; D013997:Time Factors; D016896:Treatment Outcome
D002800:Cholinesterase Inhibitors; D048448:Phenylcarbamates; D000068836:Rivastigmine