Long-term safety and efficacy of donepezil in patients with dementia with lewy bodies: Results from a 52-week, open-label, multicenter extension study

Manabu Ikeda, Etsuro Mori, Kenji Kosaka, Eizo Iseki, Mamoru Hashimoto, Noriyuki Matsukawa, Kazutaka Matsuo, Masaki Nakagawa, Sadao Katayama, Yasuto Higashi, Tatsuo Yamada, Yuichi Maruki, Satoshi Orimo, Aoi Yoshiiwa, Haruo Hanyu, Masayuki Yokochi, Takemi Kimura, Koichi Mizoguchi, Aki Nakanishi, Tadashi TsukamotoNorio Taniguchi, Koichi Okamoto, Tatsuru Kitamura, Yoko Nakano, Tomonobu Kato, Kenichi Shimada, Masanori Hiji, Yasumasa Yoshiyama, Yuri Kitamura, Satoshi Takahashi, Masahiro Akishita, Yukihiko Washimi, Yasuji Yamamoto, Miyuki Kobayashi, Fukashi Udaka, Yasushi Osaki, Hiroaki Hino, Takashi Kanda, Toshifumi Kishimoto, Hiroaki Oguro, Toshimasa Matsuoka, Yasuhiro Tsugu, Naoki Fujii, Yasuhiro Kawase

Research output: Contribution to journalArticlepeer-review

46 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)229-241
Number of pages13
JournalDementia and geriatric cognitive disorders
Volume36
Issue number3-4
DOIs
Publication statusPublished - 2013 Sep

Keywords

  • Cholinesterase inhibitors
  • Cognitive fluctuations
  • Dementia with Lewy bodies
  • Donepezil

ASJC Scopus subject areas

  • Geriatrics and Gerontology
  • Cognitive Neuroscience
  • Psychiatry and Mental health

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