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估算肾小球滤过率与非糖尿病患者强化血压控制的风险-获益特征:一项随机临床试验的事后分析。

Estimated glomerular filtration rate and the risk-benefit profile of intensive blood pressure control amongst nondiabetic patients: a post hoc analysis of a randomized clinical trial.

机构信息

Harold Simmons Center for Kidney Disease Research and Epidemiology, Division of Nephrology and Hypertension, University of California Irvine Medical Center, Orange, CA, USA.

Dialysis Unit, Obi Clinic, Osaka, Osaka, Japan.

出版信息

J Intern Med. 2018 Mar;283(3):314-327. doi: 10.1111/joim.12701. Epub 2017 Nov 19.

Abstract

BACKGROUND

The Systolic Blood Pressure Intervention Trial (SPRINT; ClinicalTrials.gov, NCT01206062) reported reduced cardiovascular events by intensive blood pressure (BP) control amongst hypertensive patients without diabetes. However, the risk-benefit profile of intensive BP control may differ across estimated glomerular filtration rate (eGFR) levels.

METHODS

This is a post hoc analysis of the SPRINT. Nondiabetic hypertensive adults (n = 9361) with eGFR >20 mL per min per 1.73 m were enrolled from 102 US facilities between November 2010 and March 2013 and were followed up until August 2015 (median follow-up, 3.26 years). Patients were randomly assigned to either a systolic BP target of <120 or <140 mmHg (for intensive or standard treatment, respectively). The outcomes of interests were the development of (i) fatal and nonfatal major cardiovascular events and (ii) acute kidney injury (AKI).

RESULTS

The cardiovascular benefit from intensive treatment was attenuated with lower eGFR (P  = 0.019), whereas eGFR did not modify the adverse effect on AKI (P  = 0.179). Amongst 891 participants with eGFR <45 mL per min per 1.73 m , intensive treatment did not reduce the cardiovascular outcome (54/446 vs. 54/445 events in the standard group, respectively; hazard ratio [HR], 0.92; 95% CI, 0.62-1.38) with an absolute rate difference (ARD) of -0.02 (95% CI, -0.07 to +0.03) per 100 patient-years, whereas it increased AKI (62/446 vs. 38/445 events in the standard group; HR, 1.73; 95% CI, 1.12-2.66) with an ARD of +1.93 (95% CI, +1.88 to +1.97) per 100 patient-years.

CONCLUSIONS

Intensive BP control may provide little or no benefit and even be harmful for patients with moderate-to-advanced chronic kidney disease.

摘要

背景

收缩压干预试验(SPRINT;ClinicalTrials.gov,NCT01206062)报告称,在没有糖尿病的高血压患者中,通过强化血压(BP)控制可降低心血管事件。然而,强化 BP 控制的风险效益特征可能因估计肾小球滤过率(eGFR)水平而异。

方法

这是 SPRINT 的事后分析。2010 年 11 月至 2013 年 3 月,来自美国 102 个机构的 9361 名患有 eGFR >20 mL/min/1.73 m 的非糖尿病高血压成年人被纳入研究,并随访至 2015 年 8 月(中位随访时间 3.26 年)。患者被随机分配至收缩压目标值<120mmHg 或<140mmHg(分别为强化治疗和标准治疗)。感兴趣的结局为(i)致命和非致命的主要心血管事件,以及(ii)急性肾损伤(AKI)。

结果

随着 eGFR 降低,强化治疗的心血管获益减弱(P=0.019),而 eGFR 并未改变对 AKI 的不利影响(P=0.179)。在 eGFR<45 mL/min/1.73 m 的 891 名参与者中,强化治疗并未降低心血管结局(标准组分别为 54/446 例事件和 54/445 例事件;风险比 [HR],0.92;95%CI,0.62-1.38),每 100 患者年的绝对差值(ARD)为-0.02(95%CI,-0.07 至 +0.03),而 AKI 增加(标准组分别为 62/446 例事件和 38/445 例事件;HR,1.73;95%CI,1.12-2.66),每 100 患者年的 ARD 为+1.93(95%CI,+1.88 至 +1.97)。

结论

强化 BP 控制可能对中重度慢性肾脏病患者几乎没有益处,甚至可能有害。

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