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Baseline characteristics and treatment-emergent risk factors associated with cerebrovascular event and death with risperidone in dementia patients

Howard, R; Costafreda, SG; Karcher, K; Coppola, D; Berlin, JA; Hough, D; (2016) Baseline characteristics and treatment-emergent risk factors associated with cerebrovascular event and death with risperidone in dementia patients. British Journal of Psychiatry , 209 (5) pp. 378-384. 10.1192/bjp.bp.115.177683. Green open access

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Abstract

BACKGROUND: Use of antipsychotics to treat behavioural symptoms of dementia has been associated with increased risks of mortality and stroke. Little is known about individual patient characteristics that might be associated with bad or good outcomes. AIMS: We examined the risperidone clinical trial data to look for individual patient characteristics associated with these adverse outcomes. METHOD: Data from all double-blind randomised controlled trials of risperidone in dementia patients (risperidone n = 1009, placebo n = 712) were included. Associations between characteristics and outcome were analysed based on crude incidences and exposure-adjusted incidence rates, and by time-to-event analyses using Cox proportional hazards regression. Interactions between treatment (risperidone or placebo) and characteristic were analysed with a Cox proportional hazards regression model with main effects for treatment and characteristic in addition to the interaction term. RESULTS: Baseline complications of depression (treatment by risk factor interaction on cerebrovascular adverse event (CVAE) hazard ratio (HR): P = 0.025) and delusions (P = 0.043) were associated with a lower relative risk of CVAE in risperidone-treated patients (HR = 1.47 and 0.54, respectively) compared to not having the complication (HR = 5.88 and 4.16). For mortality, the only significant baseline predictor in patients treated with risperidone was depression, which was associated with a lower relative risk (P<0.001). The relative risk of mortality was increased in risperidone patients treated with anti-inflammatory medications (P = 0.021). CONCLUSIONS: Only anti-inflammatory medications increased mortality risk with risperidone. The reduced risks of CVAE in patients with comorbid depression and delusions, and of mortality with depression, may have clinical implications when weighing the benefits and risks of treatment with risperidone in patients with dementia.

Type: Article
Title: Baseline characteristics and treatment-emergent risk factors associated with cerebrovascular event and death with risperidone in dementia patients
Open access status: An open access version is available from UCL Discovery
DOI: 10.1192/bjp.bp.115.177683
Publisher version: http://dx.doi.org/10.1192/bjp.bp.115.177683
Language: English
Additional information: Copyright © The Royal College of Psychiatrists 2016. All rights reserved. This is an author-produced electronic version of an article accepted for publication in the British Journal of Psychiatry. The definitive publisher-authenticated version is available online at http://bjp.rcpsych.org
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Division of Psychiatry
URI: https://discovery.ucl.ac.uk/id/eprint/1474438
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