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Original Investigation |

Effect of Discontinuation of Antihypertensive Treatment in Elderly People on Cognitive Functioning—the DANTE Study Leiden A Randomized Clinical Trial

Justine E. F. Moonen, MD1; Jessica C. Foster-Dingley, MSc1; Wouter de Ruijter, MD, PhD2; Jeroen van der Grond, PhD3; Anne Suzanne Bertens, MD3,4; Mark A. van Buchem, MD, PhD3; Jacobijn Gussekloo, MD, PhD2; Huub A. Middelkoop, PhD5,6; Marieke J. H. Wermer, MD, PhD5; Rudi G. J. Westendorp, MD, PhD7,8; Anton J. M. de Craen, PhD4; Roos C. van der Mast, MD, PhD1,9
[+] Author Affiliations
1Department of Psychiatry, Leiden University Medical Center, Leiden, the Netherlands
2Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands
3Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands
4Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands
5Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands
6Section of Health, Medical and Neuropsychology, Department of Psychology, Leiden University, Leiden, the Netherlands
7Leyden Academy on Vitality and Aging, Leiden University Medical Center, Leiden, the Netherlands
8Center for Healthy Aging, Department of Public Health, University of Copenhagen, Cophenhagen, Denmark
9Department of Psychiatry, Collaborative Antwerp Psychiatric Research Institute (CAPRI), University of Antwerp, Antwerp, Belgium
JAMA Intern Med. 2015;175(10):1622-1630. doi:10.1001/jamainternmed.2015.4103.
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Importance  Observational studies indicate that lower blood pressure (BP) increases risk for cognitive decline in elderly individuals. Older persons are at risk for impaired cerebral autoregulation; lowering their BP may compromise cerebral blood flow and cognitive function.

Objective  To assess whether discontinuation of antihypertensive treatment in older persons with mild cognitive deficits improves cognitive, psychological, and general daily functioning.

Design, Setting, and Participants  A community-based randomized clinical trial with a blinded outcome assessment at the 16-week follow-up was performed at 128 general practices in the Netherlands. A total of 385 participants 75 years or older with mild cognitive deficits (Mini-Mental State Examination score, 21-27) without serious cardiovascular disease who received antihypertensive treatment were enrolled in the Discontinuation of Antihypertensive Treatment in Elderly People (DANTE) Study Leiden from June 26, 2011, through August 23, 2013 (follow-up, December 16, 2013). Intention-to-treat analyses were performed from January 20 through April 11, 2014.

Interventions  Discontinuation (n = 199) vs continuation (n = 186) of antihypertensive treatment (allocation ratio, 1:1).

Main Outcomes and Measures  Change in the overall cognition compound score. Secondary outcomes included changes in scores on cognitive domains, the Geriatric Depression Scale–15, Apathy Scale, Groningen Activity Restriction Scale (functional status), and Cantril Ladder (quality of life).

Results  Compared with 176 participants undergoing analysis in the control (continuation) group, 180 in the intervention (discontinuation) group had a greater increase (95% CI) in systolic BP (difference, 7.36 [3.02 to 11.69] mm Hg; P = .001) and diastolic BP (difference, 2.63 [0.34 to 4.93] mm Hg; P = .03). The intervention group did not differ from the control group in change (95% CI) in overall cognition compound score (0.01 [−0.14 to 0.16] vs −0.01 [−0.16 to 0.14]; difference, 0.02 [−0.19 to 0.23]; P = .84). The intervention and control groups did not differ significantly in secondary outcomes, including differences (95% CIs) in change in compound scores of the 3 cognitive domains (executive function, −0.07 [−0.29 to 0.15; P = .52], memory, 0.08 [−0.12 to 0.29; P = .43], and psychomotor speed, −0.85 [−1.72 to 0.02; P = .06]), symptoms of apathy (0.17 [−0.65 to 0.99; P = .68]) and depression (0.14 [−0.20 to 0.48; P = .41]), functional status (−0.72 [−1.52 to 0.09; P = .08]), and quality-of-life score (−0.09 [−0.34 to 0.16; P = .46]). Adverse events were equally distributed.

Conclusions and Relevance  In older persons with mild cognitive deficits, discontinuation of antihypertensive treatment did not improve cognitive, psychological, or general daily functioning at the 16-week follow-up.

Trial Registration  trialregister.nl Identifier: NTR2829

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Figure 1.
CONSORT Flowchart of the Study

MMSE indicates Mini-Mental State Examination; MRI, magnetic resonance imaging.

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Figure 2.
Change in Systolic and Diastolic Blood Pressure Over Time

Data markers represent means; error bars, SEs.

aIndicates a significant difference (P < .001) for comparison between the intervention and control groups at 6, 10, and 16 weeks. P values were calculated using an independent-sample t test.

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Figure 3.
Change in Overall Cognitive Compound Score in Subgroups of Participants

Data markers represent standardized mean difference of the overall cognition compound score; error bars, 95% CI. Groningen Activity Restriction Scale (GARS) scores and Mini-Mental State Examination (MMSE) scores are described in the Outcomes subsection of the Methods section. Magnetic resonance imaging (MRI) microbleeds data were missing for 6 participants; cerebral blood flow (CBF) data, for 14 participants. WMH indicates white matter hyperintensities.

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