[Effects of the discontinuation of antihyper-tensive treatment on neuropsychiatric symptoms and quality of life in nursing home residents with dementia (DANTON). A multicentre, open-label, blinded-outcome, randomised controlled trial].

Background: The benefit-harm balance of antihypertensive treatment in older adults with advanced dementia is unclear. This study assesses whether discontinuing antihypertensive treatment reduces neuropsychiatric symptoms (NPS) and maintains quality of life (QoL) in nursing home residents with dementia.

Methods: This outcome-blinded RCT (trial registration: NL7365) randomised Dutch long-term care residents with moderate-to-severe dementia and systolic blood pressure (SBP) ≤160mmHg during antihypertensive treatment (planned sample size n=492) to either antihypertensive treatment discontinuation (n=101) or usual care (n=104). Outcomes were NPS (Neuropsychiatric Inventory-Nursing Home [NPI-NH]) and QoL (Qualidem) at 16 weeks.

Results: 205 participants (median age 86 years [IQR 80-90]; 79.5% female; median SBP 134mmHg [IQR 123-146]) were included. Randomisation ceased prematurely 29 months after start randomisation because of safety concerns, combined with lacking benefits. No significant differences were found between groups for NPI-NH (mean difference 1.6 [95%CI -2.3 to 5.6]) or Qualidem (mean difference -2.5 [95%CI -6.0 to 1.0]). Serious adverse events, such as cardiovascular events or death, occurred in 36% (discontinuation) and 24% (usual care) of the participants (adjusted hazard ratio 1.65 [95%CI 0.98 to 2.79], at a median of 135 (IQR 66-209) days in the discontinuation and 103 (IQR 54-171) days in the usual care group).

Conclusion: Because of lacking benefits and an observed increase in adverse events, proactive discontinuation of antihypertensive treatment is not recommended in older adults with dementia.