Novartis Pharma AG, Basel, Switzerland.
Novartis Healthcare Pvt Ltd., Hyderabad, India.
Int J Cardiol. 2021 May 15;331:164-171. doi: 10.1016/j.ijcard.2021.01.061. Epub 2021 Feb 3.
PARADIGM-HF demonstrated superiority of sacubitril/valsartan (sac/val) over enalapril in patients with heart failure with reduced ejection fraction (HFrEF). However, patients in clinical practice may differ in their characteristics and overall risk compared with patients in clinical trials, and additional outcomes can be observed in real world (RW). Hence, a systematic review was conducted to identify and describe RW data on sac/val.
RW studies evaluating the effects of sac/val in adult patients with HFrEF with a sample size ≥100 were identified via MEDLINE® and Embase® from 2015 to January 2020. Citations were screened, critically appraised and relevant data were extracted.
A total of 68 unique studies were identified. Nearly half of the studies were conducted in Europe (n = 34), followed by the US (n = 15) and Asia (n = 11). Median follow-up period varied from 1 to 19 months. Mean age ranged between 48.7 and 79.0 years; patients were mostly male and in New York Heart Association (NYHA) functional class II/III, and mean left ventricular ejection fraction varied between 23%and 38%. Of studies performing comparisons, most reported superior efficacy of sac/val in reducing the risk of HF hospitalisations, all-cause hospitalisations, and all-cause mortality as compared to standard-of-care. Many studies reported significant improvements in NYHA functional class and reduction in biomarker levels post sac/val. Hypotension and hyperkalaemia were the most frequently reported adverse events.
This comprehensive overview of currently available RW evidence on sac/val complements the evidence from randomised controlled trials, substantiating its effectiveness in heterogeneous real-world HF populations.
PARADIGM-HF 研究表明，对于射血分数降低的心力衰竭（HFrEF）患者，沙库巴曲缬沙坦（sac/val）优于依那普利。然而，与临床试验中的患者相比，临床实践中的患者在特征和总体风险方面可能存在差异，并且在真实世界（RW）中可以观察到其他结果。因此，进行了系统评价，以确定和描述 RW 中关于 sac/val 的数据。
通过 MEDLINE®和 Embase®从 2015 年到 2020 年 1 月，检索评价沙库巴曲缬沙坦在样本量≥100 名 HFrEF 成年患者中的效果的 RW 研究。筛选引文，进行批判性评价，并提取相关数据。
共确定了 68 项独特的研究。近一半的研究在欧洲（n=34）进行，其次是美国（n=15）和亚洲（n=11）。中位随访时间从 1 至 19 个月不等。平均年龄在 48.7 至 79.0 岁之间；患者主要为男性，纽约心脏协会（NYHA）功能分级 II/III 级，平均左心室射血分数在 23%至 38%之间。进行比较的研究中，大多数报告沙库巴曲缬沙坦在降低心力衰竭住院、全因住院和全因死亡率风险方面优于标准治疗。许多研究报告沙库巴曲缬沙坦后 NYHA 功能分级显著改善，生物标志物水平降低。低血压和高钾血症是最常报告的不良事件。
本研究对目前 RW 中关于 sac/val 的证据进行了全面综述，补充了随机对照试验的证据，证实了其在异质性真实世界 HF 人群中的有效性。
