Long-term safety and efficacy of donepezil in patients with dementia with Lewy bodies: results from a 52-week, open-label, multicenter extension study.
OBJECTIVE
To investigate the safety and efficacy of long-term administration (52 weeks) of donepezil in patients with dementia with Lewy bodies (DLB).


METHODS
This was a 52-week, multicenter, open-label extension study. Up to 8 weeks after the completion of the preceding randomized, placebo-controlled trial (RCT), patients started treatment with 3 mg of donepezil daily for 2 weeks, followed by 5 mg daily for the remaining 50 weeks. Cognitive function, behavioral and psychiatric symptoms, cognitive fluctuations, and caregiver burden were assessed using the Mini-Mental State Examination, Neuropsychiatric Inventory, Cognitive Fluctuation Inventory, and the Zarit Caregiver Burden Interview, respectively. Safety parameters were monitored throughout.


RESULTS
In total, 108 patients were enrolled in the study. Cognitive function and dementia-related behavioral symptoms, including cognitive fluctuations, were improved after the start of donepezil treatment, and improvement was maintained for 52 weeks. Reduction in caregiver burden observed in the preceding RCT returned to the baseline level at 52 weeks. There was no significant imbalance in the incidence of adverse events (AEs) by onset time, and delayed AE onset induced by the long-term administration of donepezil was unlikely to appear.


CONCLUSIONS
The long-term administration of donepezil at 5 mg/day was well tolerated in patients with DLB and is expected to exhibit lasting effects, improving impaired cognitive function and psychiatric symptoms up to 52 weeks.
Department of Neuropsychiatry, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.
Manabu
M
Ikeda
Etsuro
E
Mori
Kenji
K
Kosaka
Eizo
E
Iseki
Mamoru
M
Hashimoto
Noriyuki
N
Matsukawa
Kazutaka
K
Matsuo
Masaki
M
Nakagawa
D000368:Aged; D000369:Aged, 80 and over; D003627:Data Interpretation, Statistical; D018450:Disease Progression; D000077265:Donepezil; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007189:Indans / Q000009:adverse effects* / Q000627:therapeutic use*; D020961:Lewy Body Disease / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D018697:Nootropic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D010300:Parkinson Disease / Q000150:complications / Q000523:psychology; D010880:Piperidines / Q000009:adverse effects* / Q000627:therapeutic use*; D016896:Treatment Outcome
D007189:Indans; D018697:Nootropic Agents; D010880:Piperidines; D000077265:Donepezil