Modest Effects of Intensive Blood Pressure-Lowering on Quality of Life in Patients at High Cardiovascular Risk: The ESPRIT Trial.

This study aimed to compare the effects of intensive vs standard BP-lowering treatment strategies on long-term change in HRQoL among hypertensive patients with high cardiovascular risk.

本研究旨在比较强化与标准血压降低治疗策略对高心血管风险高血压患者长期健康相关生活质量(HRQoL)变化的影响。

Methods

The ESPRIT (Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing Risk of Vascular Events) trial was an open-label, blinded-outcome, randomized controlled trial. Participants were randomly assigned to receive either intensive BP-lowering treatment (targeting standard office systolic blood pressure [SBP] to <120 mm Hg) or standard BP-lowering treatment (targeting office SBP to <140 mm Hg).

ESPRIT（降低收缩压以减少血管事件风险的强化治疗效果）试验是一项开放标签、盲法结果的随机对照试验。参与者被随机分配接受强化降压治疗（目标是将标准办公室收缩压[SBP]降至<120毫米汞柱）或标准降压治疗（目标是将办公室SBP降至<140毫米汞柱）。

HRQoL was assessed by using the 5-level EuroQol Five Dimensions Questionnaire (EQ-5D-5L) at baseline and the final follow-up visit.

通过使用5级欧洲五维健康量表（EQ-5D-5L）在基线和最终随访时评估健康相关生活质量（HRQoL）。

Covariance analyses were applied to evaluate the effect of treatment assignment on changes in HRQoL.

使用协方差分析评估治疗分配对健康相关生活质量（HRQoL）变化的影响。

Results

The current study included 5,398 participants in the intensive treatment group and 5,406 participants in the standard treatment group.

当前研究包括5,398名参与者在强化治疗组和5,406名参与者在标准治疗组。

Over 3.4 years of follow-up, the EQ-5D visual analog scale scores increased by 0.56 point in the intensive treatment group and decreased by 0.50 point in the standard treatment group, resulting in a mean difference of 1.26 (95% CI: 0.55 to 1.98; P < 0.001).

在3.4年的随访期间，强化治疗组的EQ-5D视觉模拟评分增加了0.56分，而标准治疗组的评分下降了0.50分，导致平均差异为1.26分（95%置信区间：0.55至1.98；P < 0.001）。

Compared with the standard treatment, the intensive treatment was associated with a 16% higher likelihood of meaningful improvement than worsening in EQ-5D visual analog scale (relative risk: 1.16; 95% CI: 1.04-1.30; P = 0.007).

与标准治疗相比，强化治疗与EQ-5D视觉模拟评分有意义改善而非恶化的可能性高出16%（相对风险：1.16；95%置信区间：1.04-1.30；P = 0.007）。

Categorical changes from baseline to the final follow-up visit in 5 domains between the 2 groups showed no statistical differences.

在两个组别中，从基线到最终随访访问的5个领域内的分类变化没有显示出统计学差异。

Conclusions

Intensive BP treatment, targeting office SBP to <120 mm Hg, produced modest benefits to HRQoL among hypertensive patients with high cardiovascular risk.

针对办公室收缩压<120毫米汞柱的强化血压治疗，为高心血管风险的高血压患者带来了适度的健康相关生活质量（HRQoL）改善。

(Effects of Intensive Systolic Blood Pressure Lowering Treatment in Reducing Risk of Vascular Events [ESPRIT]; NCT04030234).

(强化收缩压降低治疗减少血管事件风险的影响研究[ESPRIT]; NCT04030234).