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沙库巴曲缬沙坦对射血分数降低的心力衰竭的肾脏作用:一项真实世界的 1 年随访研究。

Renal effects of Sacubitril/Valsartan in heart failure with reduced ejection fraction: a real life 1-year follow-up study.

机构信息

Internal Medicine and Geriatrics, IRCCS-INRCA, Ancona, Italy.

Department of Clinical and Molecular Sciences, University "Politecnica Delle Marche", Ancona, Italy.

出版信息

Intern Emerg Med. 2019 Nov;14(8):1287-1297. doi: 10.1007/s11739-019-02111-6. Epub 2019 May 30.

Abstract

Real-life data confirming the favourable renal outcome in patients with heart failure (HF) treated with Sacubitril/Valsartan, previously found in several trials (RCTs), are still scant. We evaluated the renal effects of Sacubitril/Valsartan in a real-life sample of HF patients. Observational analysis of 54 consecutive outpatients affected by HF with reduced ejection fraction (HFrEF) and clinical indication for Sacubitril/Valsartan. Patients were evaluated at baseline (T0) and after six (T6) and twelve (T12) months after initiating Sacubitril/Valsartan and compared with a group of 30 historical controls. Mean age: 65.5 ± 11.7 years. Older patients: 29 (53.7%). Mean baseline estimated glomerular filtration rate (eGFR): 59.4 ± 19.2 ml/min/1.73 m. Patients with chronic kidney disease (CKD), defined by an eGFR < 60 ml/min/1.73 m, were 29 (53.7%). Sacubitril/Valsartan was less titrated in both older patients and patients with CKD. There were no changes in diuretics during follow-up. Systolic blood pressure (BP) decreased during follow-up (p = 0.014), while left ventricular ejection fraction (LVEF) slighly increased (p < 0.001). Renal function improved after 12 months compared to historical controls (p for interaction < 0.001) and a greater benefit was found in subjects aged < 65 years (p for interaction = 0.002) and patients with CKD (p for interaction = 0.009). A statistically (p = 0.009), but not clinically significant increase in serum potassium was also found, regardless of age and CKD. This is the first study focused on the renal effects of Sacubitril/Valsartan in HFrEF patients followed for 12 months in a real-life clinical context. The improved eGFR, despite lower BP, represents an important confirmation outside the peculiar world of RCTs.

摘要

尽管在真实世界的临床试验环境中观察到 12 个月,但此前在几项试验(RCT)中发现,沙库巴曲缬沙坦治疗心力衰竭(HF)患者的有利肾脏结局的真实数据仍然很少。我们评估了沙库巴曲缬沙坦在 HF 患者真实样本中的肾脏作用。对 54 例连续接受射血分数降低的心力衰竭(HFrEF)且临床指征适合沙库巴曲缬沙坦的门诊患者进行观察性分析。患者在开始沙库巴曲缬沙坦时(T0)和 6 个月(T6)和 12 个月(T12)后进行评估,并与 30 名历史对照者进行比较。平均年龄:65.5±11.7 岁。老年患者:29 例(53.7%)。基线估算肾小球滤过率(eGFR)平均值:59.4±19.2ml/min/1.73m。有 29 例(53.7%)患者患有慢性肾脏病(CKD),定义为 eGFR<60ml/min/1.73m。在老年患者和 CKD 患者中,沙库巴曲缬沙坦的滴定剂量较低。随访期间利尿剂没有变化。随访期间收缩压(BP)下降(p=0.014),左心室射血分数(LVEF)略有升高(p<0.001)。与历史对照相比,12 个月后肾功能改善(交互作用 p<0.001),年龄<65 岁的患者获益更大(交互作用 p=0.002),CKD 患者获益更大(交互作用 p=0.009)。无论年龄和 CKD 如何,还发现血钾水平呈统计学意义上(p=0.009)但无临床意义的升高。这是第一项在真实临床环境中对 12 个月内 HFrEF 患者沙库巴曲缬沙坦肾脏作用进行研究的研究。尽管血压较低,但 eGFR 的改善是 RCT 特有领域之外的一个重要确认。

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