Importance There are currently no proven treatments to
reduce the risk of mild cognitive impairment and dementia.
Objective.
To evaluate the
effect of intensive blood pressure control on risk of dementia.
Design, Setting, and Participants.
Randomized clinical
trial conducted at 102 sites in the United States and Puerto Rico among adults
aged 50 years or older with hypertension but without diabetes or history of
stroke. Randomization began on November 8, 2010. The trial was stopped early
for benefit on its primary outcome (a composite of cardiovascular events) and
all-cause mortality on August 20, 2015. The final date for follow-up of
cognitive outcomes was July 22, 2018.
Interventions.
Participants
were randomized to a systolic blood pressure goal of either less than 120 mm Hg
(intensive treatment group; n = 4678) or less than 140 mm Hg (standard
treatment group; n = 4683).
Main Outcomes and Measures.
The primary
cognitive outcome was occurrence of adjudicated probable dementia. Secondary
cognitive outcomes included adjudicated mild cognitive impairment and a
composite outcome of mild cognitive impairment or probable dementia.
Results.
Among 9361
randomized participants (mean age, 67.9 years; 3332 women [35.6%]), 8563
(91.5%) completed at least 1 follow-up cognitive assessment. The median
intervention period was 3.34 years. During a total median follow-up of 5.11
years, adjudicated probable dementia occurred in 149 participants in the
intensive treatment group vs 176 in the standard treatment group (7.2 vs 8.6
cases per 1000 person-years; hazard ratio [HR], 0.83; 95% CI, 0.67-1.04).
Intensive BP control significantly reduced the risk of mild cognitive
impairment (14.6 vs 18.3 cases per 1000 person-years; HR, 0.81; 95% CI,
0.69-0.95) and the combined rate of mild cognitive impairment or probable
dementia (20.2 vs 24.1 cases per 1000 person-years; HR, 0.85; 95% CI,
0.74-0.97).
Conclusions and Relevance.
Among
ambulatory adults with hypertension, treating to a systolic blood pressure goal
of less than 120 mm Hg compared with a goal of less than 140 mm Hg did not
result in a significant reduction in the risk of probable dementia. Because of
early study termination and fewer than expected cases of dementia, the study
may have been underpowered for this end point.
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