title: Subgroup analysis of US and non-US patients in a global study of high-dose donepezil (23 mg) in moderate and severe Alzheimer's disease.
abstract: To better understand responses in the large number of US-based patients included in a global trial of donepezil 23 mg/d versus 10 mg/d for moderate-to-severe Alzheimer's disease (AD), post hoc exploratory analyses were performed to assess the efficacy and safety in US and non-US (rest of the world [RoW]) patient subgroups. In both subgroups, donepezil 23 mg/d was associated with significantly greater cognitive benefits than donepezil 10 mg/d. Significant global function benefits of donepezil 23 mg/d over 10 mg/d were also observed in the US subgroup only. Compared with RoW patients, US patients had relatively more severe AD, had been treated with donepezil 10 mg/d for longer periods prior to the start of the study, and a higher proportion took concomitant memantine. In both subgroups, donepezil had acceptable tolerability; overall incidence of treatment-emergent adverse events was higher in patients receiving donepezil 23 mg/d compared with donepezil 10 mg/d.
authors.affiliation: Brown Alpert Medical School, Providence, RI 02906, USA. ssalloway@butler.org
authors.forename: Stephen
authors.initials: S
authors.lastname: Salloway
authors.forename: Jacobo
authors.initials: J
authors.lastname: Mintzer
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Cummings
authors.forename: David
authors.initials: D
authors.lastname: Geldmacher
authors.forename: Yijun
authors.initials: Y
authors.lastname: Sun
authors.forename: Jane
authors.initials: J
authors.lastname: Yardley
authors.forename: Joan
authors.initials: J
authors.lastname: Mackell
mesh_terms: D000368:Aged; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000235:genetics; D000704:Analysis of Variance; D001057:Apolipoproteins E / Q000235:genetics; D000077265:Donepezil; D015259:Dopamine Agents / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007189:Indans / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008559:Memantine / Q000627:therapeutic use; D009483:Neuropsychological Tests; D018697:Nootropic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D010880:Piperidines / Q000008:administration & dosage* / Q000009:adverse effects; D012720:Severity of Illness Index; D014481:United States
chemical_list: D001057:Apolipoproteins E; D015259:Dopamine Agents; D007189:Indans; D018697:Nootropic Agents; D010880:Piperidines; D000077265:Donepezil; D008559:Memantine