Department of Cardiovascular Medicine, Faculty of Medical Sciences, Kyushu University.
Saitama Citizens Medical Center.
Circ J. 2021 Apr 23;85(5):584-594. doi: 10.1253/circj.CJ-20-0854. Epub 2021 Mar 16.
In the Prospective Comparison of angiotensin receptor neprilysin inhibitor (ARNI) With ACEi to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) study, treatment with sacubitril/valsartan reduced the primary outcome of cardiovascular (CV) death and heart failure (HF) hospitalization compared with enalapril in patients with chronic HF and reduced ejection fraction (HFrEF). A prospective randomized trial was conducted to assess the efficacy and safety of sacubitril/valsartan in Japanese HFrEF patients.
In the Prospective comparison of ARNI with ACEi to determine the noveL beneficiaL trEatment vaLue in Japanese Heart Failure patients (PARALLEL-HF) study, 225 Japanese HFrEF patients (New York Heart Association [NYHA] class II-IV, left ventricular ejection fraction [LVEF] ≤35%) were randomized (1 : 1) to receive sacubitril/valsartan 200 mg bid or enalapril 10 mg bid. Over a median follow up of 33.9 months, no significant between-group difference was observed for the primary composite outcome of CV death and HF hospitalization (HR 1.09; 95% CI 0.65-1.82; P=0.6260). Early and sustained reductions in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline were observed with sacubitril/valsartan compared with enalapril (between-group difference: Week 2: 25.7%, P<0.01; Month 6: 18.9%, P=0.01, favoring sacubitril/valsartan). There was no significant difference in the changes in NYHA class and Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score at Week 8 and Month 6. Sacubitril/valsartan was well tolerated with fewer study drug discontinuations due to adverse events, although the sacubitril/valsartan group had a higher proportion of patients with hypotension.
In Japanese patients with HFrEF, there was no difference in reduction in the risk of CV death or HF hospitalization between sacubitril/valsartan and enalapril, and sacubitril/valsartan was safe and well tolerated.
在血管紧张素受体脑啡肽酶抑制剂（ARNI）与血管紧张素转换酶抑制剂（ACEi）治疗心力衰竭患者的前瞻性比较（PARADIGM-HF）研究中，与依那普利相比，沙库巴曲缬沙坦可降低慢性射血分数降低的心力衰竭（HFrEF）患者的主要心血管（CV）死亡和心力衰竭（HF）住院复合终点。一项前瞻性随机试验旨在评估沙库巴曲缬沙坦在日本 HFrEF 患者中的疗效和安全性。
在评估 ARNI 与 ACEi 在日本心力衰竭患者中的新型治疗获益的前瞻性比较（PARALLEL-HF）研究中，225 例日本 HFrEF 患者（纽约心脏协会[NYHA]心功能 II-IV 级，左心室射血分数[LVEF]≤35%）按 1:1 随机分为沙库巴曲缬沙坦 200 mg 每日两次或依那普利 10 mg 每日两次。中位随访 33.9 个月，CV 死亡和 HF 住院的主要复合终点无显著组间差异（HR 1.09；95%CI 0.65-1.82；P=0.6260）。与依那普利相比，沙库巴曲缬沙坦可早期和持续降低 N 末端脑钠肽前体（NT-proBNP）基线水平（组间差异：第 2 周：25.7%，P<0.01；第 6 个月：18.9%，P=0.01，沙库巴曲缬沙坦组更优）。第 8 周和第 6 个月时，NYHA 心功能分级和堪萨斯城心肌病问卷（KCCQ）临床综合评分的变化无显著差异。沙库巴曲缬沙坦耐受性良好，因不良事件导致的停药率较低，尽管沙库巴曲缬沙坦组低血压患者比例较高。
在日本 HFrEF 患者中，与依那普利相比，沙库巴曲缬沙坦并未降低 CV 死亡或 HF 住院风险，且沙库巴曲缬沙坦安全且耐受良好。
