Concomitant use of psychotropics and donepezil in Japanese patients with dementia: Pooled postmarketing surveillance data analysis

Background/Purpose: Psychotropics are administered to control behavioral and psychological symptoms of dementia. In 2005, the Food and Drug Administration (FDA) issued alerts regarding their use as antipsychotics in elderly patients with dementia-related psychosis. Guidelines on psychotropic use were also recently established in Japan; however, few studies have reported on the actual usage of psychotropics among patients with dementia in clinical settings. The aim of this study was to estimate the frequency of psychotropic use in patients with Alzheimer's disease receiving donepezil. Methods: Data from six prospective, postmarketing studies of donepezil in patients with Alzheimer's disease conducted between 1999 and 2011 were pooled for analysis. Patient and clinical characteristics at baseline were analyzed descriptively. The proportion of psychotropics used concomitantly with donepezil was calculated for all patients and for patients divided into types of psychotropics used, sex, age, and study time period. As for the study time period, studies were divided into two groups: the period before the FDA alert was issued (1994-2004) and the period after (2005-2011). Results: A total of 14,726 patients were analyzed (67.0% women, aged 79.3 +/- 7.2 years). The overall proportion of psychotropic use was 24.2%. The number of psychotropics used was one in 8.2% of patients, two in 8.1%, and >= 3 in 5.5%. The types of psychotropics used were as follows: typical antipsychotics, 7.8%; atypical antipsychotics, 4.4%; antidepressants, 5.7%; anxiolytics, 6.4%; and hypnotics, 11.0% (% does not sum up to 24.2% due to multiple use). With regards to the time periods, in studies conducted between 1999 and 2004 versus those between 2005 and 2011, the proportions were 31.7% and 21.3%, respectively. Conclusion: Psychotropic use was seen in a quarter of patients with dementia receiving donepezil in Japan. Additionally, the overall proportion decreased after the alert issued by the FDA in 2005. Copyright (C) 2016, Asia Pacific League of Clinical Gerontology & Geriatrics. Published by Elsevier Taiwan LLC. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).