Original ArticlesSafety and Effectiveness of Donepezil on Behavioral Symptoms in Patients With Alzheimer DiseaseCarrasco, Manuel Martin MD*; Agüera, Luis MD†; Gil, Pedro MD‡; Moríñigo, Angel MD§; Leon, Teresa MD, PhD∥Author Information *Clínica Padre Menni, Pamplona †Hospital 12 de Octubre ‡Hospital Clínico San Carlos ∥Pfizer España, Madrid §Hospital de Valme, Sevilla, Spain This study was carried out in Spain from August 2000 to March 2002 and was sponsored by Pfizer. Reprints: Manuel Martín Carrasco, MD, Clínica Padre Menni, Avenida de Marcelo Celayeta, 10, 31014 Pamplona, Navarra (e-mail: [email protected]). The authors declare no conflicts of interest. Received July 29, 2010 Accepted January 10, 2011 Alzheimer Disease & Associated Disorders: October–December 2011 - Volume 25 - Issue 4 - p 333-340 doi: 10.1097/WAD.0b013e318212ab7a Buy Metrics 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. © 2011 Lippincott Williams & Wilkins, Inc.