缬沙坦与氨氯地平的疗效及血压降低对终末期肾病发病率的影响：VALUE试验

Effects of valsartan vs amlodipine and achieved lower blood pressure on the incidence of end-stage kidney disease: The VALUE Trial.

作者信息

Olsen Eirik, Jamerson Kenneth, Schmieder Roland E, Søraas Camilla L, Mariampillai Julian E, Mancia Giuseppe, Kjeldsen Sverre E, Heimark Sondre, Mehlum Maria H, Liestøl Knut, Larstorp Anne C K, Halvorsen Lene V, Høieggen Aud, Burnier Michel, Rostrup Morten, Julius Stevo, Weber Michael A

机构信息

The Norwegian University of Science and Technology, Trondheim, Norway; St. Olav´s University Hospital, Trondheim, Norway.

University of Michigan, Ann Arbor, MI, USA.

出版信息

Eur J Intern Med. 2025 Mar;133:55-63. doi: 10.1016/j.ejim.2024.12.021. Epub 2024 Dec 18.

DOI:10.1016/j.ejim.2024.12.021

PMID:39694747

Abstract

BACKGROUND

There is a paucity of data investigating the impact of antihypertensive drug classes and blood pressure (BP) treatment targets on the incidence of end-stage kidney disease (ESKD). In patients with high-risk hypertension aged 50-80 years or above, we aimed to, 1) compare effects of valsartan, an angiotensin receptor blocker, with amlodipine, a calcium channel blocker and, 2) assess the effect of achieving systolic BP <135 vs ≥135 mmHg on the ESKD incidence.

METHODS

The VALUE Trial was a multicenter prospective double-blinded randomized clinical trial in patients with essential hypertension and high cardiovascular risk including known coronary disease, left ventricular hypertrophy and previous stroke, in which ESKD was a secondary endpoint defined as progression to kidney transplant and/or dialysis. Patients were randomized to either valsartan or amlodipine, with other anti-hypertensive medications as add-on if needed to reach the systolic BP target of <140 mmHg. Cox proportional hazards ratio (HR) was used to compare different treatment groups and achieved systolic BP <135 with ≥135 mmHg, during 3-6 years of follow-up.

RESULTS

15,245 patients were randomized and followed until 63,631 patient-years with only 90 patients lost to follow-up. The primary outcome, a composite of cardiac morbidity and mortality, was neutral between valsartan and amlodipine. On valsartan 47 patients (0.61 %) and on amlodipine 50 patients (0.66 %) developed ESKD (HR=1.02, 95 % CI 0.68-1.52, p =0.94). Achieved SBP <135 mmHg was strongly related to less ESKD (n =9/5036 patients, 0.2 %) compared with achieved SBP ≥135 mmHg (n =73/8766 patients, 0.8 %) (HR=0.28, CI 0.14-0.58, p <0.001).

CONCLUSIONS

In hypertensive patients with a high cardiovascular risk, valsartan and amlodipine have a similar impact on the incidence of end-stage kidney disease. Achieving SBP <135 mmHg, averaging 128.8/77.3 mmHg, is highly efficacious in kidney protection.

摘要

背景

关于抗高血压药物类别和血压（BP）治疗目标对终末期肾病（ESKD）发病率影响的数据较少。在年龄50 - 80岁及以上的高危高血压患者中，我们旨在：1）比较血管紧张素受体阻滞剂缬沙坦与钙通道阻滞剂氨氯地平的效果；2）评估收缩压（SBP）降至<135 mmHg与≥135 mmHg对ESKD发病率的影响。

方法

VALUE试验是一项针对原发性高血压和高心血管风险患者（包括已知冠心病、左心室肥厚和既往中风患者）的多中心前瞻性双盲随机临床试验，其中ESKD是一个次要终点，定义为进展至肾移植和/或透析。患者被随机分为缬沙坦组或氨氯地平组，必要时可加用其他抗高血压药物以达到收缩压<140 mmHg的目标。在3 - 6年的随访期间，使用Cox比例风险比（HR）来比较不同治疗组以及收缩压<135 mmHg与≥135 mmHg的情况。

结果

15245例患者被随机分组并随访至63631患者年，仅90例患者失访。主要结局，即心脏发病率和死亡率的综合指标，在缬沙坦组和氨氯地平组之间无差异。缬沙坦组有47例患者（0.61%）发生ESKD，氨氯地平组有50例患者（0.66%）发生ESKD（HR = 1.02，95%CI 0.68 - 1.52，p = 0.94）。与收缩压≥135 mmHg（8766例患者中有73例，0.8%）相比，收缩压<135 mmHg与较少的ESKD发生密切相关（5036例患者中有9例，0.2%）（HR = 0.28，CI 0.14 - 0.58，p < 0.001）。