Evidence map›Paper›PMID 38970547›Full record

Trial reportAge and ageing2024

Effects of the discontinuation of antihypertensive treatment on neuropsychiatric symptoms and quality of life in nursing home residents with dementia (DANTON): a multicentre, open-label, blinded-outcome, randomised controlled trial.

Jonathan M K Bogaerts, Jacobijn Gussekloo, Bianca E M de Jong-Schmit, Saskia Le Cessie, Simon P Mooijaart, Roos C van der Mast, Wilco P Achterberg, Rosalinde K E Poortvliet

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Age and ageing, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Interventions for preventing falls in older people in care facilities.The Cochrane database of systematic reviews · 2025
    Pooled it
  5. Pooled it
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Observational
  12. Challenging the status quo: deprescribing antihypertensive medication in older adults in primary care.The British journal of general practice : the journal of the Royal College of General Practitioners · 2024
    Article
  13. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Jonathan M K BogaertsDepartment of Public Health and Primary Care, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands.ORCID 0000-0001-6438-6705
Jacobijn GusseklooDepartment of Public Health and Primary Care, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands.
Bianca E M de Jong-SchmitDepartment of Public Health and Primary Care, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands.
Saskia Le CessieLUMC Center for Medicine for Older People, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands.
Simon P MooijaartLUMC Center for Medicine for Older People, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands.ORCID 0000-0003-3106-3568
Roos C van der MastLUMC Center for Medicine for Older People, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands.
Wilco P AchterbergDepartment of Public Health and Primary Care, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands.ORCID 0000-0001-9227-7135
Rosalinde K E PoortvlietDepartment of Public Health and Primary Care, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, the Netherlands.

Funding

Leiden University Medical CenterNetherlands Organisation for Health Research and DevelopmentNetherlands Organisation for Health Research and Development 733050835
6 · The paper itself

Abstract

backgroundBased on observational studies and randomised controlled trials (RCTs), the benefit-harm balance of antihypertensive treatment in older adults with dementia is unclear.

objectiveTo assess whether discontinuing antihypertensive treatment reduces neuropsychiatric symptoms (NPSs) and maintains quality of life (QoL) in nursing home residents with dementia.

designOpen-label, blinded-outcome RCT. Randomisation 1:1, stratified by nursing home organisation and baseline NPS. Trial registration: NL7365. SUBJECTS: Dutch long-term care residents with moderate-to-severe dementia and systolic blood pressure (SBP) ≤160 mmHg during antihypertensive treatment. Exclusion criteria included heart failure NYHA-class-III/IV, recent cardiovascular events/procedures or life expectancy <4 months (planned sample size n = 492). MEASUREMENTS: Co-primary outcomes NPS (Neuropsychiatric Inventory-Nursing Home [NPI-NH]) and QoL (Qualidem) at 16 weeks.

resultsFrom 9 November 2018 to 4 May 2021, 205 participants (median age 85.8 [IQR 79.6-89.5] years; 79.5% female; median SBP 134 [IQR 123-146] mmHg) were randomised to either antihypertensive treatment discontinuation (n = 101) or usual care (n = 104). Safety concerns, combined with lacking benefits, prompted the data safety and monitoring board to advice a premature cessation of randomisation. At 16-week follow-up, no significant differences were found between groups for NPI-NH (adjusted mean difference 1.6 [95% CI -2.3 to 5.6]; P = 0.42) or Qualidem (adjusted mean difference - 2.5 [95% CI -6.0 to 1.0]; P = 0.15). Serious adverse events (SAEs) occurred in 36% (discontinuation) and 24% (usual care) of the participants (adjusted hazard ratio 1.65 [95% CI 0.98-2.79]). All 32-week outcomes favoured usual care.

conclusionHalfway through this study, a non-significant increased SAE risk associated with discontinuing antihypertensive treatment was observed, and an associated interim analysis showed that significant worthwhile health gain for discontinuation of antihypertensive treatment was unlikely. This unbeneficial benefit-harm balance shows that discontinuation of antihypertensive treatment in this context does not appear to be either safe or beneficial enough to be recommended in older adults with dementia.

Indexed as

Antihypertensive AgentsDementiaHomes for the AgedNursing HomesQuality of LifeAgedAged, 80 and overBlood PressureFemaleHumansHypertensionMaleNetherlandsTreatment OutcomeWithholding TreatmentAntihypertensive Agentsantihypertensive treatmentdementiadeprescribinghypertensionolder peoplerandomised controlled trial

Identifiers

PMID38970547
PMCPMC11227112

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.