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真实世界环境中沙库巴曲缬沙坦治疗高血压合并心力衰竭患者的有效性和安全性:中国的一项回顾性研究。

Effectiveness and safety of sacubitril/valsartan for patients with hypertension and heart failure in the real-world setting: A retrospective study in China.

机构信息

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

出版信息

J Clin Pharm Ther. 2022 Oct;47(10):1539-1547. doi: 10.1111/jcpt.13699. Epub 2022 Jun 1.

Abstract

WHAT IS KNOWN AND OBJECTIVE

Hypertension (HP) is associated with heart failure (HF). Sacubitril/valsartan (sac/val) has been approved for primary HP by China Food and Drug Administration (CFDA) in June 2021. The present study aimed to provide evidence on the effectiveness and safety of sac/val in Chinese patients complicated with HP and HF.

METHODS

This retrospective study was conducted on adult patients diagnosed with HP and HF and treated with sac/val between July 2020 and December 2020. The potential risk factors for the discontinuation events caused by sac/val-related adverse events (AEs) were explored. The data, including blood pressure (BP), cardiac indicators, corresponding values on echocardiographic parameters, unplanned visits, and AEs throughout 3-12 months, were collected.

RESULTS AND DISCUSSION

A total of 446 eligible patients were included in this study. The discontinuation events of sac/val were mainly attributed to its AEs (hypotension, hyperkalemia, and deterioration in kidney function). Univariate analysis revealed that history of chronic kidney disease, atrial fibrillation, higher values of serum creatinine, serum uric acid, serum N-terminal pro B-type natriuretic peptide, and lower estimated glomerular filtration rate were potential risk factors for discontinuation. Patients who maintained sac/val therapy throughout 3-12 months showed significantly improved values of clinical BP, cardiac indicators, and echocardiographic parameters compared to those at baseline (p < 0.0001).

WHAT IS NEW AND CONCLUSION

Sac/val was effective on BP and improved cardiac function in patients complicated with HP and HF. The physicians should focus on patients with renal dysfunction to take timely precautions to improve tolerability for sac/val.

摘要

已知和目的

高血压(HP)与心力衰竭(HF)有关。沙库巴曲缬沙坦(sac/val)已于 2021 年 6 月被中国食品药品监督管理局(CFDA)批准用于原发性 HP。本研究旨在为 sac/val 在中国 HP 和 HF 合并患者中的疗效和安全性提供证据。

方法

本回顾性研究纳入了 2020 年 7 月至 2020 年 12 月期间接受 sac/val 治疗的成人 HP 和 HF 患者。探讨了因 sac/val 相关不良反应(AE)导致停药事件的潜在危险因素。收集了 3-12 个月期间的血压(BP)、心脏指标、超声心动图参数的相应值、未计划就诊和 AE 等数据。

结果与讨论

共纳入 446 例符合条件的患者。sac/val 的停药事件主要归因于其 AE(低血压、高钾血症和肾功能恶化)。单因素分析显示,慢性肾脏病史、心房颤动、血清肌酐、血尿酸、血清 N 端脑利钠肽前体、估算肾小球滤过率较高是停药的潜在危险因素。与基线相比,3-12 个月内维持 sac/val 治疗的患者临床 BP、心脏指标和超声心动图参数均显著改善(p<0.0001)。

创新与结论

sac/val 对 HP 和 HF 合并患者的 BP 有效,改善了心脏功能。医生应关注肾功能障碍患者,及时采取预防措施,提高对 sac/val 的耐受性。

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