PIONEER-HF 试验中达到的剂量水平下沙库巴曲缬沙坦的疗效和安全性。
Efficacy and Safety of Sacubitril/Valsartan by Dose Level Achieved in the PIONEER-HF Trial.
机构信息
TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
出版信息
JACC Heart Fail. 2020 Oct;8(10):834-843. doi: 10.1016/j.jchf.2020.06.008. Epub 2020 Aug 12.
OBJECTIVES
This study sought to evaluate the efficacy and safety of sacubitril/valsartan according to dose level achieved in the PIONEER-HF (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode) trial.
BACKGROUND
In patients hospitalized for acute decompensated heart failure (ADHF), in-hospital initiation and continuation of sacubitril/valsartan as compared with enalapril is well tolerated, achieves a greater reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP), and reduces the risk of cardiovascular death or rehospitalization for HF through 8 weeks. However, not all patients achieve the target dose of sacubitril/valsartan, and its efficacy and safety in such patients are of interest.
METHODS
PIONEER-HF was a randomized, double-blind, active-controlled trial of sacubitril/valsartan versus enalapril in 881 patients stabilized during hospitalization for ADHF. Blinded study medication was administered for 8 weeks, with initial dosing selected based on the systolic blood pressure at randomization and titrated toward a target of sacubitril/valsartan 97/103 mg twice daily, or enalapril 10 mg twice daily, with an algorithm based on systolic blood pressure and the investigator's assessment of tolerability.
RESULTS
At 4 weeks, 199 (55%) patients allocated to sacubitril/valsartan and 211 (60%) patients allocated to enalapril were dispensed the target dose. Baseline characteristics were similar in the 2 treatment groups within each dose level. There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
CONCLUSIONS
In hemodynamically stabilized patients with ADHF, the efficacy and safety of sacubitril/valsartan are generally consistent across dose levels. (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode [PIONEER-HF]; NCT02554890).
目的
本研究旨在评估依那普利相比，达格列净在射血分数降低的心力衰竭（HF）患者中的疗效和安全性。
背景
在因急性失代偿性心力衰竭（ADHF）住院的患者中，与依那普利相比，住院期间起始并持续应用沙库巴曲缬沙坦可更好耐受，降低 N 末端 B 型利钠肽前体（NT-proBNP）水平，降低 HF 再住院或心血管死亡风险，持续 8 周。然而，并非所有患者均能达到沙库巴曲缬沙坦的目标剂量，因此该药物在这类患者中的疗效和安全性值得关注。
方法
PIONEER-HF 是一项沙库巴曲缬沙坦对比依那普利治疗 ADHF 患者的随机、双盲、阳性对照试验，共纳入 881 例患者。患者随机分组后，接受盲法研究药物治疗 8 周，起始剂量根据随机时的收缩压选择，并滴定至沙库巴曲缬沙坦 97/103mg，每日 2 次，或依那普利 10mg，每日 2 次的目标剂量。滴定方案基于收缩压和研究者对耐受性的评估。
结果
4 周时，沙库巴曲缬沙坦组 199 例（55%）和依那普利组 211 例（60%）患者达到目标剂量。两组中，每个剂量水平内的患者基线特征相似。不同剂量水平下，沙库巴曲缬沙坦对 NT-proBNP 降低的影响（p=0.69）、心血管死亡或 HF 再住院的降低（p=0.42）以及 8 周内特定不良事件的发生率无差异。
结论
在血流动力学稳定的 ADHF 患者中，沙库巴曲缬沙坦的疗效和安全性与剂量水平相关。
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