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沙库巴曲缬沙坦用于高血压合并心力衰竭患者:不同年龄、药物剂量和肾功能的真实世界经验

Sacubitril/Valsartan in Heart Failure with Hypertension Patients: Real-World Experiences on Different Ages, Drug Doses, and Renal Functions.

作者信息

Guan Yingyun, Li Xiaoye, Li Hui, Ren Jinmei, Tang Kouming, Zhang Chi, Gu Zhichun, Li Xiaoyu, Lv Qianzhou, Bian Xiaolan

机构信息

Department of Pharmacy, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200025, China.

Department of Pharmacy, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.

出版信息

High Blood Press Cardiovasc Prev. 2023 Nov;30(6):561-572. doi: 10.1007/s40292-023-00606-0. Epub 2023 Nov 18.

Abstract

INTRODUCTION

Hypertension is a significant risk factor in heart failure for worldwide patients. More than half of hypertensive patients suffer from heart failure. Recently, sacubitril/valsartan (sac/val) has been approved as an antihypertensive agent in China and Japan. Additionally, it is not approved for treating hypertension in Europe or the USA.

AIM

To accumulate more real-world experiences to investigate the effectiveness and optimize clinical medication of sac/val in hypertensive patients with heart failure.

METHODS

We retrospectively enrolled adult patients diagnosed with hypertension (HTN) and heart failure (HF) and newly treated with sac/val. The baseline characteristics and clinical outcomes were retrospectively extracted from electronic medical records (EMR) in three centers. The efficacy and safety of sac/val were first analyzed in all enrolled patients. Stratified analyses were conducted in patients with different ages (≥ 65, < 65), maximum tolerated doses (≥ 200 mg/days, < 200 mg/days), and renal functions (e-GFR ≥ 60 ml/min/1.73 m, < 60 ml/min/1.73 m).

RESULTS

Overall, 794 patients diagnosed with both HF and HTN were included in our study. During follow-up, significant reductions were found in blood pressure (BP) (SBP 12.8 ± 21.2 mmHg, P < 0.001, DBP 7.1 ± 16.5 mmHg, P < 0.001), and cardiac biomarkers (cardiac troponin 1.78 ± 19.1 ng/mL, P < 0.001, NT-proBNP 1403 ± 6937 pg/mL, P < 0.001) from baseline. In stratification analyses, the lower dosage group earned a higher BP control rate (83.4% vs. 75.6%, P = 0.025) and an overall improvement rate of cardiac indicators (61.3% vs. 48.0%, P = 0.002). The younger patients' group had significantly less cumulative hazard of recurrent cerebral-cardiovascular events than the elder group (log-rank P value < 0.001). Patients with renal dysfunction were observed with more AE incidences.

CONCLUSIONS

Sac/val could reduce BP and improve cardiac structural and functional parameters in hypertensive patients with HF, even with less than target doses. However, more attention should be paid to older patients and renal dysfunction patients when using sac/val because of additional risks in adverse events.

摘要

引言

高血压是全球心力衰竭患者的一个重要危险因素。超过一半的高血压患者患有心力衰竭。最近,沙库巴曲缬沙坦(沙库/缬)在中国和日本已被批准作为一种抗高血压药物。此外,它在欧洲或美国未被批准用于治疗高血压。

目的

积累更多真实世界经验,以研究沙库/缬在高血压合并心力衰竭患者中的有效性并优化临床用药。

方法

我们回顾性纳入了诊断为高血压(HTN)和心力衰竭(HF)并新接受沙库/缬治疗的成年患者。从三个中心的电子病历(EMR)中回顾性提取基线特征和临床结局。首先在所有纳入患者中分析沙库/缬的疗效和安全性。对不同年龄(≥65岁、<65岁)、最大耐受剂量(≥200mg/天、<200mg/天)和肾功能(估算肾小球滤过率[e-GFR]≥60ml/min/1.73m²、<60ml/min/1.73m²)的患者进行分层分析。

结果

总体而言,我们的研究纳入了794例同时诊断为HF和HTN的患者。在随访期间,发现血压(BP)(收缩压[SBP]12.8±21.2mmHg,P<0.001,舒张压[DBP]7.1±16.5mmHg,P<0.001)和心脏生物标志物(心肌肌钙蛋白1.78±19.1ng/mL,P<0.001,N末端脑钠肽前体[NT-proBNP]1403±6937pg/mL,P<0.001)较基线有显著降低。在分层分析中,较低剂量组的血压控制率更高(83.4%对75.6%,P=0.025),心脏指标总体改善率更高(61.3%对48.0%,P=0.002)。年轻患者组复发性心脑血管事件的累积风险显著低于老年组(对数秩检验P值<0.001)。观察到肾功能不全患者的不良事件发生率更高。

结论

沙库/缬可降低高血压合并HF患者的血压,并改善心脏结构和功能参数。即使剂量未达到目标剂量,也有此效果。然而,在使用沙库/缬时,由于不良事件存在额外风险,应更多关注老年患者和肾功能不全患者。

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