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Good Intentions, But What About Unintended Consequences?

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Managing the behavioral and psychological symptoms of dementia (BPSD) that accompany cognitive decline— including agitation, anxiety, depression, aggression, sleep problems, and socially inappropriate behaviors—is one of the biggest challenges of… Click to show full abstract

Managing the behavioral and psychological symptoms of dementia (BPSD) that accompany cognitive decline— including agitation, anxiety, depression, aggression, sleep problems, and socially inappropriate behaviors—is one of the biggest challenges of day-to-day care. These symptoms are associated with many of the negative outcomes of dementia, including hospitalizations; increased placement in nursing homes; caregiver stress, including depression and lost income; and decreased quality of life for both patient and caregiver. Despite the fact that, in the USA, no drugs have been approved by the US FDA for BPSD, the current mainstay of treatment is the (primarily off-label) use of psychotropic medications [1, 2]. Of the agents used to treat BPSD, atypical antipsychotics have the strongest evidence base, although their benefits are moderate at best (effect size 0.13–0.16) [3]. Any such benefits must be balanced against the risk of adverse events for this often frail population. For atypical antipsychotics, these include cognitive worsening, somnolence, abnormal gait and falls, and significant increase in risk of stroke and mortality [3]. Based upon mortality concerns, the FDA and regulatory bodies in several countries, including the UK, have warned against the use of antipsychotics in dementia. Against this backdrop of significant concerns about the risk–benefit balance of antipsychotic use, initiatives to reduce off-label use for BPSD have been initiated in the USA (the Centers for Medicare and Medicaid Services’ [CMS] National Partnership to Improve Dementia Care in Nursing Homes) and the UK, as described in this issue by Stocks et al. [6]. In such efforts, the main quality indicator is often the percent of patients prescribed an antipsychotic, which, in those without a primary psychotic disorder, is presumed to be potentially inappropriate treatment for BPSD [4, 5]. The study by Stocks et al. [6] in this issue, as well as the related work of Donegan et al. [7], both analyzing the same primary care data registry (Clinical Practice Research Datalink), provide important first steps in evaluating antipsychotic reduction efforts in the UK. Donegan et al. [7] found that, over a 10-year period (2005–2015), the use of antipsychotics in dementia halved (22.1% in 2005 to 11.4% in 2015); most of this decrease resulted from reduction in conventional antipsychotics (9% in 2005 to 2% in 2015), with a smaller decrease in atypical antipsychotics (13.6% in 2005 to 9.7% in 2015). Donegan et al. [7] also found that the use of hypnotics decreased (from 14.3 to 9.5%), whereas the use of anxiolytics remained stable and the use of antidepressants increased (28 to 36.6%). Of note, no data were presented on the use of mood stabilizers, which are often used as an alternative to antipsychotics for BPSD. The Stocks et al. [6] study, with slightly different This comment refers to the article available at doi:10.1007/s40264017-0538-x.

Keywords: atypical antipsychotics; use; unintended consequences; good intentions; intentions unintended; 2005 2015

Journal Title: Drug Safety
Year Published: 2017

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