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种族和民族对收缩压干预试验(SPRINT)临床结局的影响:一项随机临床试验。

Clinical Outcomes by Race and Ethnicity in the Systolic Blood Pressure Intervention Trial (SPRINT): A Randomized Clinical Trial.

机构信息

Frances Payne Bolton School of Nursing, Case Western Reserve University, USA.

Wake Forest School of Medicine/Department of Epidemiology and Prevention, Section on Cardiovascular Medicine, USA.

出版信息

Am J Hypertens. 2017 Dec 8;31(1):97-107. doi: 10.1093/ajh/hpx138.

Abstract

BACKGROUND

The Systolic Blood Pressure Intervention Trial (SPRINT) showed that targeting a systolic blood pressure (SBP) of ≤ 120 mm Hg (intensive treatment) reduced cardiovascular disease (CVD) events compared to SBP of ≤ 140 mm Hg (standard treatment); however, it is unclear if this effect is similar in all racial/ethnic groups.

METHODS

We analyzed SPRINT data within non-Hispanic White (NHW), non-Hispanic Black (NHB), and Hispanic subgroups to address this question. High-risk nondiabetic hypertensive patients (N = 9,361; 30% NHB; 11% Hispanic) 50 years and older were randomly assigned to intensive or standard treatment. Primary outcome was a composite of the first occurrence of a myocardial infarction, acute coronary syndrome, stroke, decompensated heart failure, or CVD death.

RESULTS

Average postbaseline SBP was similar among NHW, NHB, and Hispanics in both treatment arms. Hazard ratios (HRs) (95% confidence interval) (intensive vs. standard treatment groups) for primary outcome were 0.70 (0.57-0.86), 0.71 (0.51-0.98), 0.62 (0.33-1.15) (interaction P value = 0.85) in NHW, NHB, and Hispanics. CVD mortality HRs were 0.49 (0.29-0.81), 0.77 (0.37-1.57), and 0.17 (0.01-1.08). All-cause mortality HRs were 0.61 (0.47-0.80), 0.92 (0.63-1.35), and 1.58 (0.73-3.62), respectively. A test for differences among racial/ethnic groups in the effect of treatment assignment on all-cause mortality was not significant (Hommel-adjusted P value = 0.062) after adjustment for multiple comparisons.

CONCLUSION

Targeting a SBP goal of ≤ 120 mm Hg compared to ≤ 140 mm Hg led to similar SBP control and was associated with similar benefits and risks among all racial ethnic groups, though NHBs required an average of ~0.3 more medications.

CLINICAL TRIALS REGISTRATION

Trial Number NCT01206062, ClinicalTrials.gov Identifier at https://clinicaltrials.gov/ct2/show/NCT01206062.

摘要

背景

收缩压干预试验(SPRINT)表明,与收缩压(SBP)目标值为 140mmHg 的标准治疗相比,将 SBP 控制在 120mmHg 以下(强化治疗)可降低心血管疾病(CVD)事件发生率;然而,目前尚不清楚这种效果是否在所有种族/民族群体中相似。

方法

我们在非西班牙裔白人(NHW)、非西班牙裔黑人(NHB)和西班牙裔亚组内分析了 SPRINT 数据,以解决这个问题。纳入了 9361 例年龄在 50 岁及以上的高危非糖尿病高血压患者(30%为 NHB,11%为西班牙裔),并将其随机分配至强化治疗组或标准治疗组。主要终点为首次发生心肌梗死、急性冠脉综合征、卒中等复合终点事件,或 CVD 死亡。

结果

强化治疗组和标准治疗组中,NHW、NHB 和西班牙裔患者的平均基线后 SBP 相似。主要终点事件的风险比(HR)(95%置信区间)(强化 vs. 标准治疗组)分别为 0.70(0.57-0.86)、0.71(0.51-0.98)和 0.62(0.33-1.15)(交互 P 值=0.85)。NHW、NHB 和西班牙裔患者的 CVD 死亡率 HR 分别为 0.49(0.29-0.81)、0.77(0.37-1.57)和 0.17(0.01-1.08)。全因死亡率 HR 分别为 0.61(0.47-0.80)、0.92(0.63-1.35)和 1.58(0.73-3.62)。对全因死亡率治疗效果的种族/民族差异进行检验,在进行多次比较调整后差异无统计学意义(Hommel 调整 P 值=0.062)。

结论

与 SBP 目标值为 140mmHg 的标准治疗相比,将 SBP 目标值控制在 120mmHg 以下可带来相似的 SBP 控制效果,且与所有种族/民族群体的获益和风险相似,尽管 NHB 组需要平均多服用约 0.3 种药物。

临床试验注册

试验编号 NCT01206062,ClinicalTrials.gov 标识符:https://clinicaltrials.gov/ct2/show/NCT01206062。

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