Effect of Intensive vs Standard Blood Pressure Control on Probable Dementia A Randomized Clinical Trial
Effect of Intensive vs Standard Blood Pressure Control on Probable Dementia A Randomized Clinical Trial
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DOI：
10.1001/jama.2018.21442
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发表时间：
2019-02-12
影响因子：
120.7
通讯作者：
Wright, Clinton B.
中科院分区：
文献类型：
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作者：
Williamson, Jeff D.;Pajewski, Nicholas M.;Wright, Clinton B.
重要性目前还没有被证实的治疗方法可以降低轻度认知障碍和痴呆的风险。目的评估强化血压控制对痴呆风险的影响。设计、设置和参与者在美国和波多黎各的102个地点进行随机临床试验，对象为50岁或以上患有高血压但没有糖尿病或中风病史的成年人。随机化于2010年11月8日开始。该试验于2015年8月20日提前停止，以改善其主要结果(心血管事件的组合)和全因死亡率。认知结果的最终随访日期是2018年7月22日。干预参与者被随机分配到收缩压目标小于120 mm Hg(强化治疗组；n=4678)或小于140 mm Hg(标准治疗组；n=4683)的组。主要结果和测量主要认知结果是判断的可能痴呆的发生。结果在9361名随机受试者中(平均年龄67.9岁；3332名女性[35.6%])，8563名(91.5%)完成了至少一次随访认知评估。中位干预时间为3.34年。在总共5.11年的中位随访期中，强化治疗组有149名参与者被判定为可能痴呆，而标准治疗组为176例(7.2vs8.6例/1000人年；危险比[HR]，0.83；95%CI，0.67-1.04)。强化的血压控制显著降低了轻度认知损害的风险(每1000人年14.6vs18.3例；HR，0.81；95%CI，0.69-0.95)和轻度认知损害或可能痴呆的综合发生率(每1000人年20.2vs24.1例；HR，0.85；95%CI，0.74-0.97)。结论和相关性：在患有高血压的成年人中，将收缩压目标控制在120毫米汞柱以下与将目标血压控制在140毫米汞以下并不能显著降低可能的痴呆症风险。由于研究提前终止，痴呆症病例少于预期，这项研究可能对这一终点的支持力度不足。
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.