title: Donepezil 23 mg in Asian patients with moderate-to-severe Alzheimer's disease.
abstract: BACKGROUND
  Ethnic diversity between different populations may affect treatment safety and efficacy.
  
  
  OBJECTIVE
  A subanalysis to a global trial (study 326) was carried out to ascertain the safety and efficacy of donepezil 23 mg/day compared with donepezil 10 mg/day in Asian patients with moderate-to-severe Alzheimer's disease. Changes in cognition and global functioning were measured by the Severe Impairment Battery (SIB) and Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus), respectively, at week 24.
  
  
  RESULTS
  Cognitive improvement measured by SIB score was greater with donepezil 23 mg than with donepezil 10 mg (+1.36 vs -1.56]; difference, 2.92). There was no difference between the groups in global function measured by the CIBIC-Plus (3.94 and 3.95, respectively). Overall, 119 patients (82.1%) receiving donepezil 23 mg and 56 (71.8%) receiving donepezil 10 mg experienced ≥1 treatment emergent adverse events (TEAEs). In the donepezil 23 mg group, the incidence of TEAEs was higher among patients of lower weight (<55 kg) at baseline than in those of higher weight (64 of 75 patients [85.3%] vs 55 of 70 patients [78.5%]).
  
  
  CONCLUSIONS
  The benefits and risks associated with donepezil 23 mg in Asian patients are comparable to those of the global study population.
authors.affiliation: Department of Neurology, Konkuk University Hospital, Seoul, South Korea.
authors.forename: S-H
authors.initials: SH
authors.lastname: Han
authors.affiliation: Department of Neurology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
authors.forename: J-H
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Neurology, Clinical Neuroscience Center & Neurology, Seoul National University Bundang Hospita, Gyeonggi-do, South Korea.
authors.forename: S Y
authors.initials: SY
authors.lastname: Kim
authors.affiliation: Department of Neurology, Dong-A University College of Medicine, Dong-A University Hospital, Busan, South Korea.
authors.forename: K W
authors.initials: KW
authors.lastname: Park
authors.affiliation: Department of Pharmacology, National University of Singapore and Memory Aging and Cognition Center, National University Health System, Singapore, Singapore.
authors.forename: C
authors.initials: C
authors.lastname: Chen
authors.affiliation: Department of Neurology, Neuroscience Centre, AIIMS, New Delhi, India.
authors.forename: M
authors.initials: M
authors.lastname: Tripathi
authors.affiliation: Regional Medical Advisor, Eisai Pharmaceuticals India Pvt. Ltd., Mumbai, India.
authors.forename: A
authors.initials: A
authors.lastname: Dash
authors.affiliation: Clinical Development Eisai Co. Ltd., Tokyo, Japan.
authors.forename: N
authors.initials: N
authors.lastname: Kubota
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology; D044466:Asian People; D002800:Cholinesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000077265:Donepezil; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007189:Indans / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010880:Piperidines / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D002800:Cholinesterase Inhibitors; D007189:Indans; D010880:Piperidines; D000077265:Donepezil
keywords: Asia; alzheimer disease; cognition; donepezil