Institut für Herzinfarktforschung, Klinikum Ludwigshafen, Bremserstraße 79, 67063, Ludwigshafen, Germany.
Institut für Herzinfarktforschung Ludwigshafen, Ludwigshafen, Germany.
Herz. 2024 Oct;49(5):385-392. doi: 10.1007/s00059-024-05248-z. Epub 2024 Apr 24.
Sacubitril/valsartan (Sac/Val) is the first angiotensin receptor-neprilysin inhibitor indicated for symptomatic chronic heart failure (HF) with reduced ejection fraction (HFrEF). Given most patients with HF in Germany are managed by general practitioners, AURORA-HF investigated the baseline characteristics and 1‑year follow-up of patients starting Sac/Val in primary care in Germany.
This was a prospective, multicenter, observational study, with all treatment decisions independent of participation. The only inclusion criteria were adults (age ≥ 18 years) with symptomatic HFrEF. The study comprised four groups, depending on therapy on entry: initiation of (1) Sac/Val or (2) other HF therapy; and no change in HF regimen that (3) included or (4) did not include Sac/Val. Baseline data were captured for all groups; 1‑year follow-up was recorded in groups 1 and 2.
Of 1278 patients in the baseline analyses, 513 (40.1%) had newly started Sac/Val (449 [87.5%] completing the 1‑year follow-up), 265 (20.7%) had newly started other HF regimens (245, 92.5%) with 1‑year follow-up, while 249 with Sac/Val (19.5%) and 251 without Sac/Val (19.6%) patients had unchanged therapies. Patients treated with Sac/Val had a higher New York Heart Association (NYHA) class at baseline and more often a left ventricular ejection fraction (LVEF) < 35%. The only baseline parameter significantly correlating with Sac/Val discontinuation during the 1‑year follow-up was diabetes mellitus (odds ratio: 2.44; 95% confidence interval: 1.14-5.24). In the Sac/Val group, 30.7% of patients were in NYHA class I/II on study entry, improving to 51.0% at 1‑year follow-up. In the no Sac/Val group, the corresponding rates of NYHA I and II classes were 49.8% and 58.2%, respectively. The overall adverse event profile of Sac/Val was good, with only 6.0% patients experiencing serious adverse events leading to permanent discontinuation.
In patients with symptomatic HFrEF treated in primary care, the group in whom Sac/Val was initiated was characterized by a higher NYHA class and lower LVEF compared to patients in whom Sac/Val was not initiated. Sac/Val was well tolerated, with a high proportion completing 1 year of therapy.
沙库巴曲缬沙坦（Sac/Val）是首个用于治疗射血分数降低的慢性心力衰竭（HFrEF）的血管紧张素受体-脑啡肽酶抑制剂。鉴于德国大多数心力衰竭患者由全科医生管理，AURORA-HF 研究了德国初级保健中开始使用 Sac/Val 的患者的基线特征和 1 年随访结果。
这是一项前瞻性、多中心、观察性研究，所有治疗决策均独立于参与研究。唯一的纳入标准是患有症状性 HFrEF 的成年人（年龄≥18 岁）。该研究包括四个组，根据进入时的治疗情况进行分组：开始（1）Sac/Val 或（2）其他心力衰竭治疗；以及心力衰竭治疗方案（3）不变，包括或（4）不包括 Sac/Val。所有组均记录基线数据；第 1 组和第 2 组记录 1 年随访结果。
在基线分析的 1278 例患者中，513 例（40.1%）开始新使用 Sac/Val（449 例[87.5%]完成 1 年随访），265 例（20.7%）开始新使用其他心力衰竭治疗方案（245 例，92.5%）并完成 1 年随访，而 249 例使用 Sac/Val（19.5%）和 251 例不使用 Sac/Val（19.6%）的患者未改变治疗方案。开始使用 Sac/Val 的患者基线时纽约心脏协会（NYHA）心功能分级更高，射血分数（LVEF）<35%的患者更多。唯一与 1 年随访期间 Sac/Val 停药显著相关的基线参数是糖尿病（比值比：2.44；95%置信区间：1.14-5.24）。在 Sac/Val 组中，30.7%的患者在研究入组时处于 NYHA I/II 级，1 年随访时改善至 51.0%。在无 Sac/Val 组中，NYHA I 和 II 级的相应比例分别为 49.8%和 58.2%。Sac/Val 的总体不良事件谱良好，仅有 6.0%的患者发生导致永久停药的严重不良事件。
在初级保健中治疗的有症状 HFrEF 患者中，与未开始使用 Sac/Val 的患者相比，开始使用 Sac/Val 的患者 NYHA 心功能分级更高，LVEF 更低。Sac/Val 耐受良好，有很高比例的患者完成 1 年治疗。
