title: Safety and effectiveness of donepezil on behavioral symptoms in patients with Alzheimer disease.
abstract: The objective of this study was to evaluate the prevalence and treatment responsiveness of neuropsychiatric symptoms in patients with mild to moderately severe Alzheimer disease recruited in a naturalistic treatment setting in Spain. All the patients, who matched the prescribing recommendations for donepezil and were able to participate in the study, received donepezil (5 to 10 mg/d) for 6 months. The primary outcome measure was the incidence of adverse events. Secondary outcome measures were neuropsychiatric function measured by the Neuropsychiatric Inventory (NPI), the Mini-Mental State Evaluation, and caregiver burden measured by the Zarit scale. Five hundred and twenty-nine patients were included of which 455 completed the study. The mean baseline NPI score was 19.1. Sixty-five patients (12.3%) experienced an adverse event. The most frequent adverse events were diarrhea and agitation (<2%). Seventeen patients (3%) presented with a neuropsychiatric adverse event and 11 (2%) patients presented with a neurologic adverse event over the course of the study. NPI scores improved by 34.4% over the course of the study, with all items showing a statistically significant improvement. Mini-Mental State Evaluation scores and Zarit caregiver burden scores also improved by 1.27 points and 5.9 points, respectively. This study showed a low incidence of adverse events accompanied by an improvement in the neuropsychiatric and cognitive functions in patients with mild to moderately severe Alzheimer disease treated with donepezil in a community setting in Spain. Donepezil also reduced caregiver burden.
authors.affiliation: Clínica Padre Menni, Pamplona, Spain. manuelmartin@intersep.org
authors.forename: Manuel Martin
authors.initials: MM
authors.lastname: Carrasco
authors.forename: Luis
authors.initials: L
authors.lastname: Agüera
authors.forename: Pedro
authors.initials: P
authors.lastname: Gil
authors.forename: Angel
authors.initials: A
authors.lastname: Moríñigo
authors.forename: Teresa
authors.initials: T
authors.lastname: Leon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017109:Akathisia, Drug-Induced / Q000453:epidemiology; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000523:psychology*; D003967:Diarrhea / Q000139:chemically induced / Q000453:epidemiology; D000077265:Donepezil; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007189:Indans / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D007189:Indans; D010880:Piperidines; D000077265:Donepezil