PMID- 23949147
OWN - NLM
STAT- MEDLINE
DCOM- 20140428
LR  - 20220317
IS  - 1421-9824 (Electronic)
IS  - 1420-8008 (Linking)
VI  - 36
IP  - 3-4
DP  - 2013
TI  - Long-term safety and efficacy of donepezil in patients with dementia with Lewy 
      bodies: results from a 52-week, open-label, multicenter extension study.
PG  - 229-41
LID - 10.1159/000351672 [doi]
AB  - BACKGROUND/AIMS: 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. CONCLUSION: 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.
CI  - (c) 2013 S. Karger AG, Basel.
FAU - Ikeda, Manabu
AU  - Ikeda M
AD  - Department of Neuropsychiatry, Faculty of Life Sciences, Kumamoto University, 
      Kumamoto, Japan.
FAU - Mori, Etsuro
AU  - Mori E
FAU - Kosaka, Kenji
AU  - Kosaka K
FAU - Iseki, Eizo
AU  - Iseki E
FAU - Hashimoto, Mamoru
AU  - Hashimoto M
FAU - Matsukawa, Noriyuki
AU  - Matsukawa N
FAU - Matsuo, Kazutaka
AU  - Matsuo K
FAU - Nakagawa, Masaki
AU  - Nakagawa M
CN  - Donepezil-DLB Study Investigators
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130815
PL  - Switzerland
TA  - Dement Geriatr Cogn Disord
JT  - Dementia and geriatric cognitive disorders
JID - 9705200
RN  - 0 (Indans)
RN  - 0 (Nootropic Agents)
RN  - 0 (Piperidines)
RN  - 8SSC91326P (Donepezil)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Data Interpretation, Statistical
MH  - Disease Progression
MH  - Donepezil
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Indans/*adverse effects/*therapeutic use
MH  - Lewy Body Disease/complications/*drug therapy/psychology
MH  - Male
MH  - Nootropic Agents/*adverse effects/*therapeutic use
MH  - Parkinson Disease/complications/psychology
MH  - Piperidines/*adverse effects/*therapeutic use
MH  - Treatment Outcome
FIR - Katayama, Sadao
IR  - Katayama S
FIR - Higashi, Yasuto
IR  - Higashi Y
FIR - Yamada, Tatsuo
IR  - Yamada T
FIR - Maruki, Yuichi
IR  - Maruki Y
FIR - Orimo, Satoshi
IR  - Orimo S
FIR - Yoshiiwa, Aoi
IR  - Yoshiiwa A
FIR - Hanyu, Haruo
IR  - Hanyu H
FIR - Yokochi, Masayuki
IR  - Yokochi M
FIR - Kimura, Takemi
IR  - Kimura T
FIR - Mizoguchi, Koichi
IR  - Mizoguchi K
FIR - Nakanishi, Aki
IR  - Nakanishi A
FIR - Tsukamoto, Tadashi
IR  - Tsukamoto T
FIR - Taniguchi, Norio
IR  - Taniguchi N
FIR - Okamoto, Koichi
IR  - Okamoto K
FIR - Kitamura, Tatsuru
IR  - Kitamura T
FIR - Nakano, Yoko
IR  - Nakano Y
FIR - Kato, Tomonobu
IR  - Kato T
FIR - Shimada, Kenichi
IR  - Shimada K
FIR - Hiji, Masanori
IR  - Hiji M
FIR - Yoshiyama, Yasumasa
IR  - Yoshiyama Y
FIR - Kitamura, Yuri
IR  - Kitamura Y
FIR - Takahashi, Satoshi
IR  - Takahashi S
FIR - Akishita, Masahiro
IR  - Akishita M
FIR - Washimi, Yukihiko
IR  - Washimi Y
FIR - Yamamoto, Yasuji
IR  - Yamamoto Y
FIR - Kobayashi, Miyuki
IR  - Kobayashi M
FIR - Udaka, Fukashi
IR  - Udaka F
FIR - Osaki, Yasushi
IR  - Osaki Y
FIR - Hino, Hiroaki
IR  - Hino H
FIR - Kanda, Takashi
IR  - Kanda T
FIR - Kishimoto, Toshifumi
IR  - Kishimoto T
FIR - Oguro, Hiroaki
IR  - Oguro H
FIR - Matsuoka, Toshimasa
IR  - Matsuoka T
FIR - Tsugu, Yasuhiro
IR  - Tsugu Y
FIR - Fujii, Naoki
IR  - Fujii N
FIR - Kawase, Yasuhiro
IR  - Kawase Y
EDAT- 2013/08/21 06:00
MHDA- 2014/04/29 06:00
CRDT- 2013/08/17 06:00
PHST- 2013/04/15 00:00 [accepted]
PHST- 2013/08/17 06:00 [entrez]
PHST- 2013/08/21 06:00 [pubmed]
PHST- 2014/04/29 06:00 [medline]
AID - 000351672 [pii]
AID - 10.1159/000351672 [doi]
PST - ppublish
SO  - Dement Geriatr Cogn Disord. 2013;36(3-4):229-41. doi: 10.1159/000351672. Epub 
      2013 Aug 15.