加拿大阿尔伯塔大学Paul W. Armstrong研究团队近日取得一项新成果。经过不懈努力，他们探讨了Vericiguat治疗射血分数降低心力衰竭患者的疗效。2020年3月28日出版的《新英格兰医学杂志》发表了这项成果。

Vericiguat是一种新型口服可溶性鸟苷酸环化酶刺激剂，在近期住院或接受静脉利尿剂治疗的射血分数降低心力衰竭患者中，效果尚不明确。

在这项临床3期、随机、双盲、安慰剂对照试验中，研究组招募了5050例慢性心力衰竭（纽约心脏协会II，III或IV级）且射血分数小于45%的患者，在指南药物治疗的基础上，将其随机分组，其中2526例接受Vericiguat治疗，2524例接受安慰剂治疗。

中位随访10.8个月后，Vericiguat组中有897名患者（35.5%）发生心血管原因死亡或首次因心衰住院，安慰剂组中有972名（38.5%），风险比为0.90。Vericiguat组有691例患者（27.4%）因心力衰竭住院，安慰剂组有747例（29.6%），风险比为0.90。Vericiguat组有414例患者（16.4%）发生心血管原因死亡，安慰剂组有441例（17.5%），风险比为0.93。

Vericiguat组中有957名患者（37.9%）发生全因死亡或首次因心衰住院，安慰剂组有1032名（40.5%），风险比为0.90。Vericiguat组中有9.1%的患者出现症状性低血压，安慰剂组中有7.9%；Vericiguat组中有4.0%的患者发生晕厥，安慰剂组为3.5%。

总之，在高危心力衰竭患者中，Vericiguat治疗与安慰剂相比，可显著降低心血管原因死亡或因心力衰竭住院的风险。

附：英文原文

Title: Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction | NEJM

Author: Paul W. Armstrong, M.D.,, Burkert Pieske, M.D.,, Kevin J. Anstrom, Ph.D.,, Justin Ezekowitz, M.B., B.Ch.,, Adrian F. Hernandez, M.D., M.H.S.,, Javed Butler, M.D., M.P.H., M.B.A.,, Carolyn S.P. Lam, M.B., B.S., Ph.D.,, Piotr Ponikowski, M.D.,, Adriaan A. Voors, M.D., Ph.D.,, Gang Jia, Ph.D.,, Steven E. McNulty, M.S.,, Mahesh J. Patel, M.D.,, Lothar Roessig, M.D.,, Joerg Koglin, M.D., Ph.D.,, and Christopher M. O’Connor, M.D.

Issue&Volume: 2020-03-28

Abstract: Abstract

Background

The effect of vericiguat, a novel oral soluble guanylate cyclase stimulator, in patients with heart failure and reduced ejection fraction who had recently been hospitalized or had received intravenous diuretic therapy is unclear.

Methods

In this phase 3, randomized, double-blind, placebo-controlled trial, we assigned 5050 patients with chronic heart failure (New York Heart Association class II, III, or IV) and an ejection fraction of less than 45% to receive vericiguat (target dose, 10 mg once daily) or placebo, in addition to guideline-based medical therapy. The primary outcome was a composite of death from cardiovascular causes or first hospitalization for heart failure.

Results

Over a median of 10.8 months, a primary-outcome event occurred in 897 of 2526 patients (35.5%) in the vericiguat group and in 972 of 2524 patients (38.5%) in the placebo group (hazard ratio, 0.90; 95% confidence interval [CI], 0.82 to 0.98; P=0.02). A total of 691 patients (27.4%) in the vericiguat group and 747 patients (29.6%) in the placebo group were hospitalized for heart failure (hazard ratio, 0.90; 95% CI, 0.81 to 1.00). Death from cardiovascular causes occurred in 414 patients (16.4%) in the vericiguat group and in 441 patients (17.5%) in the placebo group (hazard ratio, 0.93; 95% CI, 0.81 to 1.06). The composite of death from any cause or hospitalization for heart failure occurred in 957 patients (37.9%) in the vericiguat group and in 1032 patients (40.9%) in the placebo group (hazard ratio, 0.90; 95% CI, 0.83 to 0.98; P=0.02). Symptomatic hypotension occurred in 9.1% of the patients in the vericiguat group and in 7.9% of the patients in the placebo group (P=0.12), and syncope occurred in 4.0% of the patients in the vericiguat group and in 3.5% of the patients in the placebo group (P=0.30).

Conclusions

Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo.

DOI: 10.1056/NEJMoa1915928

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1915928