THE DANTON STUDY - DISCONTINUATION OF ANTIHYPERTENSIVE TREATMENT IN OLDER PEOPLE WITH DEMENTIA LIVING IN A NURSING HOME: RESULTS OF A RANDOMIZED CONTROLLED TRIAL

Abstract

Objective: Neuropsychiatric symptoms (NPS), such as apathy and agitation, are highly prevalent in nursing home (NH) residents with dementia. Literature suggests an association of both cerebral hypoperfusion and antihypertensive treatment (AHT) with NPS in patients with dementia. Therefore, we investigated whether discontinuation of AHT in NH residents with dementia reduces NPS and improves quality of life (QoL). Design and method: Randomized, single-blinded trial conducted in 26 Dutch NH organisations. Residents with moderate-severe dementia and a systolic blood pressure < 160 mmHg during AHT were randomized in an intervention (semi-protocolized discontinuation) and control (continuation) group during a period of 8 months. Exclusion criteria were heart failure NYHA-class-III/IV, angina pectoris, a recent cardiovascular event/reperfusion procedure, or a life-expectancy < 4 months. Co-primary endpoints were NPS (Neuropsychiatric Inventory-Nursing Home version) and QoL (Qualidem) at 4 months. Secondary endpoints include cognitive function, care dependency, general daily functioning and falls. Results: Between December 2018 and May 2021, 205 NH residents with dementia (median age 86 years-79.5% women) were randomized, of which 177 (86.3%) reached the primary endpoint at 4 months. During trial, 63 severe adverse events occurred in 61 residents. On advice of the Data Safety Monitoring Board, the study was preliminary finished in December 2021 due to futility based on the co-primary endpoints. Definitive results for all endpoints measured at 4 and 8 months follow-up will be available in April 2022. Conclusions: This is, to our knowledge, the largest AHT deprescription trial in NH residents with dementia. Based on preliminary results of this study, the benefits of deprescribing AHT in NH residents with dementia for reduction of NPS and improvement of QoL, are unclear and may not be without any potential risk.