Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIB-SantPau, CIBERCV, Universidad Autónoma de Barcelona, Calle Sant Antoni Maria Claret 167, 08025, Barcelona, Spain.
Cardiovasc Drugs Ther. 2019 Jun;33(3):307-314. doi: 10.1007/s10557-019-06858-0.
Sacubitril/valsartan reduced heart failure (HF) admissions and cardiovascular mortality in the PARADIGM-HF trial. However, real-life studies are scarce comparing daily practice patients with those of the trial. The aim of our study was to analyze the efficacy and safety of the drug in an advanced heart failure cohort and to review systematically the previous real-life studies published to date.
We performed a retrospective analysis of consecutive patients prescribed sacubitril/valsartan in a single tertiary HF clinic between September 2016 and February 2018. HF admissions before and after the initiation of the drug were assessed in a paired fashion. A systematic review of real-life studies published to date was also conducted.
Sacubitril/valsartan was started in 108 patients who were in a more advanced NYHA class and more frequently treated with mineral receptor antagonists, internal cardiac defibrillator, and cardiac resynchronization therapy than in the PARADIGM-HF trial. After a 6-month follow-up, we observed a significant reduction in the HF hospitalizations, median levels of NT-proBNP, and need for levosimendan ambulatory perfusion. Likewise, we found a significant improvement in mean LVEF and end diastolic left ventricle diameter. Regarding safety, sacubitril/valsartan was well-tolerated without any severe adverse effect.
Sacubitril/valsartan in real-life is prescribed to a more advanced HF population, which could be responsible for the difficulties in reaching high doses of the drug. However, after a 6-month follow-up, sacubitril/valsartan significantly reduces HF hospitalization and induces cardiac reverse remodeling, without remarkable adverse events.
沙库巴曲缬沙坦在 PARADIGM-HF 试验中降低了心力衰竭（HF）住院率和心血管死亡率。然而，比较试验患者和实际患者的真实世界研究很少。我们的研究目的是分析该药物在晚期心力衰竭患者中的疗效和安全性，并系统回顾迄今为止发表的真实世界研究。
我们对 2016 年 9 月至 2018 年 2 月期间在一家三级 HF 诊所连续接受沙库巴曲缬沙坦治疗的患者进行了回顾性分析。采用配对方式评估药物治疗前后 HF 住院情况。还对迄今为止发表的真实世界研究进行了系统回顾。
沙库巴曲缬沙坦开始应用于 108 例患者，这些患者的 NYHA 分级更高，更频繁地接受了矿物质受体拮抗剂、心脏内部除颤器和心脏再同步治疗，与 PARADIGM-HF 试验相比。经过 6 个月的随访，我们观察到 HF 住院率、NT-proBNP 中位数水平和左心室舒张末期直径的显著降低。同样，我们发现平均 LVEF 显著改善。关于安全性，沙库巴曲缬沙坦耐受性良好，无严重不良事件。
真实世界中沙库巴曲缬沙坦用于更晚期 HF 患者，这可能是难以达到药物高剂量的原因。然而，经过 6 个月的随访，沙库巴曲缬沙坦显著降低 HF 住院率，并诱导心脏逆重构，无显著不良事件。
