TY - JOUR
T1 - Long-term safety and efficacy of donepezil in patients with dementia with lewy bodies
T2 - Results from a 52-week, open-label, multicenter extension study
AU - Ikeda, Manabu
AU - Mori, Etsuro
AU - Kosaka, Kenji
AU - Iseki, Eizo
AU - Hashimoto, Mamoru
AU - Matsukawa, Noriyuki
AU - Matsuo, Kazutaka
AU - Nakagawa, Masaki
AU - Katayama, Sadao
AU - Higashi, Yasuto
AU - Yamada, Tatsuo
AU - Maruki, Yuichi
AU - Orimo, Satoshi
AU - Yoshiiwa, Aoi
AU - Hanyu, Haruo
AU - Yokochi, Masayuki
AU - Kimura, Takemi
AU - Mizoguchi, Koichi
AU - Nakanishi, Aki
AU - Tsukamoto, Tadashi
AU - Taniguchi, Norio
AU - Okamoto, Koichi
AU - Kitamura, Tatsuru
AU - Nakano, Yoko
AU - Kato, Tomonobu
AU - Shimada, Kenichi
AU - Hiji, Masanori
AU - Yoshiyama, Yasumasa
AU - Kitamura, Yuri
AU - Takahashi, Satoshi
AU - Akishita, Masahiro
AU - Washimi, Yukihiko
AU - Yamamoto, Yasuji
AU - Kobayashi, Miyuki
AU - Udaka, Fukashi
AU - Osaki, Yasushi
AU - Hino, Hiroaki
AU - Kanda, Takashi
AU - Kishimoto, Toshifumi
AU - Oguro, Hiroaki
AU - Matsuoka, Toshimasa
AU - Tsugu, Yasuhiro
AU - Fujii, Naoki
AU - Kawase, Yasuhiro
PY - 2013/9
Y1 - 2013/9
N2 - 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.
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.
KW - Cholinesterase inhibitors
KW - Cognitive fluctuations
KW - Dementia with Lewy bodies
KW - Donepezil
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UR - http://www.scopus.com/inward/citedby.url?scp=84884680030&partnerID=8YFLogxK
U2 - 10.1159/000351672
DO - 10.1159/000351672
M3 - Article
C2 - 23949147
AN - SCOPUS:84884680030
VL - 36
SP - 229
EP - 241
JO - Dementia and Geriatric Cognitive Disorders
JF - Dementia and Geriatric Cognitive Disorders
SN - 1420-8008
IS - 3-4
ER -