Moonen JE, Foster-Dingley JC, de Ruijter W, et al. Effect of Discontinuation of Antihypertensive Treatment in Elderly People on Cognitive Functioning—the DANTE Study Leiden: A Randomized Clinical Trial. JAMA Intern Med 2015;175(10):1622-30
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/26301603
Full text article: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2429535
| Methods | Study design: Open-label randomized controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 385 randomized
Age: 81.1 years Sex: 238 female, 147 male Participants with dementia: Mild cognitive impairment (MMSE 21 – 27) Inclusion criteria: · 75 years or older · Used antihypertensive treatment · MMSE score of 21 to 27 · Systolic blood pressure of 160 mm Hg or less, OR · Systolic blood pressure of 140 mm Hg or less if o History of peripheral arterial disease o Myocardial infarction o Coronary reperfusion procedure o Persons with diabetes mellitus Exclusion criteria: · Clinical diagnosis of dementia · Use of antihypertensives for reasons other than hypertension · Current angina pectoris · Cardiac arrhythmia · Heart failure · Myocardial infarction less than 3 years ago · Coronary reperfusion procedure less than 3 years ago · History of stroke or transient ischemic attack · Limited life expectancy Country: Netherlands Setting: Community |
| Interventions | Medicine: Antihypertensives
Withdrawal schedule: Tapered over six weeks until a maximum increase of 20mm Hg in systolic blood pressure Comparator: Usual care |
| Outcomes | Systolic blood pressure
Diastolic blood pressure Cognitive function – Executive function – Memory – Psychomotor seed – Symptoms of apathy – Depression – Function status Quality of life Adverse effects |
| Dates | Dates: June 26, 2011 to December 16, 2013
Follow-up duration: Four months |
| Funding sources | Program Priority Medicines for the Elderly, the Netherlands Organization for Health Research and Development project 113101003: http://www.zonmw.nl/nl/projecten/project-detail /effects-of-temporary-discontinuation-of- antihypertensive-treatment-in-older-patients-with- cognitive/ |
| Notes | Trial Registration trialregister.nl Identifier: NTR2829 |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Low risk | Randomization was by a computer program.
“Participants were randomly assigned, in a 1:1 ratio, to parallel discontinuation (intervention group) or continuation (control group) of anti- hypertensive treatment (Figure 1). Stratified block randomization was used (with block sizes of 4 per general practice) to ensure that intervention and control participants were equally distributed within general practices.” |
| Allocation concealment (selection bias) | Low risk | Concealment of treatment allocation was ensured by a central computerized randomization procedure. |
| Blinding of participants and personnel (performance bias) | High risk | This was an open study.
“Participants and the physicians conducting the intervention were not masked to the allocated intervention.”
|
| Blinding of outcome assessment (detection bias) | High risk | This was an open study.
“Participants and the physicians conducting the intervention were not masked to the allocated intervention.” |
| Incomplete outcome data (attrition bias) | High risk | The study states that it is an “intention-to-treat” analysis. However, participants not included in the intention-to-treat analysis due to no-follow-up measurements included:
Active group: 1 participant who died and seven who withdrew for health reasons Control group: 1 participant who died and four who withdrew for health reasons |
| Selective reporting (reporting bias) | Low risk | Pre-specified protocol was available. |
| Other bias | Low risk | Not identified |
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