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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


Salloway, Stephen, Mintzer, Jacobo, Cummings, Jeffrey L., Geldmacher, David, Sun, Yijun, Yardley, Jane, Mackell, Joan


American Journal Of Alzheimer's Disease And Other Dementias, Volume: 27, No.: 6, Pages.: 421-432

Year of Publication



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.;

Bibtex Citation

@article{Salloway_2012, doi = {10.1177/1533317512454708}, url = {}, year = 2012, month = {aug}, publisher = {{SAGE} Publications}, volume = {27}, number = {6}, pages = {421--432}, author = {S. Salloway and J. Mintzer and J. L. Cummings and D. Geldmacher and Y. Sun and J. Yardley and J. Mackell}, title = {Subgroup Analysis of {US} and Non-{US} Patients in a Global Study of High-Dose Donepezil (23 mg) in Moderate and Severe Alzheimer{textquotesingle}s Disease}, journal = {American Journal of Alzheimer{textquotesingle}s Disease and Other Dementias} }


administration & dosage, adverse effects, aged, alzheimer disease, analysis of variance, apolipoproteins e, donepezil, dopamine agents, double-blind method, drug therapy, drug therapy combination, female, genetics, humans, indans, male, memantine, neuropsychological tests, nootropic agents, piperidines, severity of illness index, therapeutic use, united states

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Cohort Study

Type of Outcomes

Physical Health

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Anti-Alzheimer medications, e.g.: donezepil, galantamine, rivastigmine, memantime