Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results evaluating VERQUVO

默克公司（纽约证券交易所代码：MRK），在美国和加拿大以外地区称为MSD，今天公布了评估VERQUVO的结果。

(vericiguat) in adult patients with stable chronic heart failure and reduced ejection fraction (HFrEF). The Phase 3 VICTOR trial comparing the efficacy of VERQUVO to placebo in patients with HFrEF without a recent worsening heart failure event treated with guideline-directed medical therapy (GDMT) did not reach statistical significance for its primary endpoint of combined time to first event of cardiovascular death or hospitalization for heart failure.

在患有稳定型慢性心力衰竭且射血分数降低（HFrEF）的成年患者中使用维利西呱（vericiguat）。III期VICTOR试验比较了VERQUVO与安慰剂在未发生近期心力衰竭恶化的HFrEF患者中的疗效，这些患者接受了指南导向的药物治疗（GDMT），但其主要终点——心血管死亡或因心力衰竭住院的首次事件联合时间——未达到统计学显著性。

In a separate pre-specified pooled analysis of patient-level data from the complementary Phase 3 VICTOR and VICTORIA trials, VERQUVO reduced the risk of the composite primary endpoint of cardiovascular death or heart failure hospitalization across these patients with a broad range of disease severity.

在针对补充的 VICTOR 和 VICTORIA 三期试验的患者层面数据进行的单独预先指定的汇总分析中，VERQUVO 降低了这些涵盖广泛疾病严重程度的患者发生心血管死亡或心力衰竭住院的主要复合终点的风险。

Results from both analyses were presented today at the European Society of Cardiology (ESC) Congress 2025 in a Hot Line session and simultaneously published in .

两项分析的结果今天在欧洲心脏病学会（ESC）2025年大会的热门会议环节上公布，并同时发表在 。

VERQUVO was initially studied and approved in patients with worsening chronic heart failure and ejection fraction less than 45% following a worsening heart failure event based on the pivotal Phase 3 VICTORIA trial. Participants in the VICTOR trial represented a well-treated group of ambulatory HFrEF patients on GDMT and 47.5% of participants had no history of hospitalization for heart failure.

VERQUVO 最初在射血分数小于 45% 的慢性心力衰竭恶化的患者中进行了研究，并基于关键的 III 期 VICTORIA 试验，在心力衰竭事件恶化后获得批准。VICTOR 试验的参与者代表了一组接受 GDMT 治疗的门诊 HFrEF 患者，其中 47.5% 的参与者没有因心力衰竭住院的历史。

Results showed that VERQUVO did not significantly reduce the risk of the primary composite outcome of time to cardiovascular death or hospitalization for heart failure, which occurred in 18% (n=549/3,053) of patients treated with VERQUVO compared to 19.1% (n=584/3,052) in the placebo group (hazard ratio [HR] 0.93; 95% confidence interval [CI] 0.83-1.04; p=0.22).

结果显示，与安慰剂组相比，VERQUVO 并未显著降低心血管死亡或因心力衰竭住院的主要复合终点事件时间风险。在 VERQUVO 治疗的患者中，18%（549/3,053）发生主要终点事件，而安慰剂组为 19.1%（584/3,052）（风险比 [HR] 0.93；95% 置信区间 [CI] 0.83-1.04；p=0.22）。

For the key secondary endpoints, cardiovascular death was numerically lower with VERQUVO (9.6%) compared to placebo (11.3%) (HR 0.83; 95% CI 0.71-0.97) and heart failure hospitalization occurred in 11.4% of patients receiving VERQUVO and 11.9% of patients receiving placebo (HR 0.95; 95% CI 0.82–1.10)..

对于关键的次要终点，与安慰剂（11.3%）相比，VERQUVO（9.6%）的心血管死亡率在数值上较低（HR 0.83；95% CI 0.71-0.97），接受VERQUVO治疗的患者中有11.4%发生心力衰竭住院，而接受安慰剂治疗的患者中有11.9%发生心力衰竭住院（HR 0.95；95% CI 0.82–1.10）。

The overall safety profile of VERQUVO in the VICTOR trial was consistent with previous clinical trials.

VERQUVO在VICTOR试验中的总体安全性与之前的临床试验一致。

“By studying patients without recent heart failure hospitalizations, the Phase 3 VICTOR trial expands our understanding of VERQUVO across the full spectrum of chronic heart failure patients with reduced ejection fraction,” said Dr. Joerg Koglin, senior vice president and head of general medicine, global clinical development, Merck Research Laboratories.

“通过研究近期没有因心力衰竭住院的患者，III 期 VICTOR 试验加深了我们对 VERQUVO 在全范围慢性射血分数减少的心力衰竭患者中的理解，”默克研究实验室高级副总裁兼全球临床开发普通医学主管 Joerg Koglin 博士表示。

“Together with the previously communicated results in VICTORIA in patients with worsening chronic heart failure and ejection fraction less than 45% following a worsening heart failure event, the results today provide valuable information and add to our understanding of heart failure and VERQUVO. We are grateful to the patients and investigators for their participation in these studies and remain confident in the role of VERQUVO for its approved indication for patients with HFrEF following a recent heart failure event and with ejection fraction less than 45% based on the pivotal Phase 3 VICTORIA trial.”.

“结合之前在VICTORIA试验中针对慢性心力衰竭恶化且射血分数低于45%的心衰事件后患者的结果，今天的结果提供了宝贵的信息，并增进了我们对心力衰竭和VERQUVO的理解。我们感谢参与这些研究的患者和研究人员，并基于关键的III期VICTORIA试验，继续对VERQUVO在近期心衰事件后、射血分数低于45%的HFrEF患者中的获批适应症保持信心。”

The Phase 3 VICTORIA trial focused exclusively on a population with worsening chronic HFrEF at high risk for cardiovascular mortality and repeated heart failure hospitalizations. In a separate pre-specified pooled analysis across VICTOR and VICTORIA, VERQUVO’s benefit was examined in a large and broad cohort.

VICTORIA 三期试验专门针对慢性 HFrEF 恶化且心血管死亡和心力衰竭反复住院风险高的群体。在对 VICTOR 和 VICTORIA 数据进行的预先设定的汇总分析中，VERQUVO 的益处在更大、更广泛的人群队列中得到了验证。

In this pooled analysis of 11,155 HFrEF patients, VERQUVO showed a statistically significant risk reduction across the primary composite endpoint of cardiovascular death or heart failure hospitalization and its components as secondary endpoints, in a broad spectrum of patients with HFrEF. No new safety signals, beyond those reported in the individual trials, emerged in the pooled analysis..

在对11,155名HFrEF患者进行的汇总分析中，VERQUVO在广泛HFrEF患者群体中显示出对主要复合终点（心血管死亡或心力衰竭住院）及其各组成部分的统计学显著风险降低，作为次要终点。除了个别试验中报告的安全性信号外，汇总分析中未出现新的安全性问题。

“While the VICTOR trial did not meet its primary endpoint, the separate pooled analysis across both VICTOR and VICTORIA did demonstrate a statistically significant reduction in the primary composite endpoint of heart failure hospitalization and cardiovascular deaths in patients with heart failure and reduced ejection fraction across the disease severity,” said Javed Butler, MD, MPH, MBA, President of the Baylor Scott and White Research Institute and Professor of Medicine at University of Mississippi in Jackson, Mississippi..

“虽然VICTOR试验未达到其主要终点，但对VICTOR和VICTORIA两项试验的汇总分析确实显示，在不同疾病严重程度的心力衰竭和射血分数降低的患者中，主要复合终点（心力衰竭住院和心血管死亡）有统计学意义上的显著减少，”德克萨斯州贝勒斯科特和怀特研究所总裁兼密西西比州杰克逊市密西西比大学医学教授Javed Butler博士表示。

The positive benefit-risk profile of VERQUVO in its approved indication in patients with HFrEF following a recent heart failure event based on the pivotal Phase 3 VICTORIA trial remains unchanged. In the U.S., VERQUVO is approved for the reduction of risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%..

基于关键的 III 期 VICTORIA 试验，VERQUVO 在近期发生心力衰竭事件的 HFrEF 患者中的获益-风险特征仍保持不变。在美国，VERQUVO 适用于降低有症状的慢性心力衰竭成人患者因心力衰竭住院或需要门诊静脉注射利尿剂后的心血管死亡和心力衰竭住院的风险，这些患者的射血分数低于 45%。

About VICTOR

关于VICTOR

VICTOR in adults with Chr

VICTOR在患有慢性肾病的成年人中

nic heart failure and educed ejection fraction) (NCT05093933) was a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase 3 study investigating the efficacy and safety of VERQUVO in adult patients with symptomatic chronic heart failure (New York Heart Association [NYHA] class II-IV) and a left ventricular ejection fraction (LVEF) of 40% or less.

尼可心力衰竭和射血分数降低 (NCT05093933）是一项随机、双盲、安慰剂对照、多中心、事件驱动的III期研究，评估了VERQUVO在患有症状性慢性心力衰竭（纽约心脏病协会[NYHA]分级II-IV级）且左心室射血分数（LVEF）为40%或更低的成年患者中的疗效和安全性。

It enrolled 6,105 patients with chronic heart failure with reduced ejection fraction (HFrEF), who had not had a recent hospitalization for heart failure within 6 months or the need for outpatient intravenous diuretics within 3 months before randomization. Patients receiving contemporary guideline-directed medical therapy (GDMT), including SGLT2-inhibitors and angiotensin receptor-neprilysin inhibitor (ARNI), were randomized to receive either VERQUVO or placebo.

该研究纳入了6,105名射血分数降低的慢性心力衰竭（HFrEF）患者，这些患者在入组前6个月内未因心力衰竭住院，或在随机分组前3个月内未需门诊静脉注射利尿剂。接受当代指南指导的药物治疗（GDMT）的患者，包括SGLT2抑制剂和血管紧张素受体-脑啡肽酶抑制剂（ARNI），被随机分配接受VERQUVO或安慰剂。

VICTOR was the first large event-driven HFrEF trial performed in the contemporary era of quadruple foundational GDMT, in a compensated ambulatory heart failure population. Merck and Bayer AG are co-developers of the VICTOR trial. The study was executed by Merck..

VICTOR 是在当代四联基础 GDMT 时代进行的首个大型事件驱动型 HFrEF 试验，针对代偿性门诊心力衰竭人群。默克公司和拜耳公司是 VICTOR 试验的共同开发者。该研究由默克公司执行。

About VICTORIA

关于VICTORIA

VICTORIA (

维多利亚 (

NCT02861534

NCT02861534

) was a randomized, placebo-controlled, parallel-group, multi-center, double-blind, Phase 3 study of VERQUVO versus placebo when given in combination with available heart failure therapies in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF) following a decompensation event, defined as heart failure hospitalization or receiving an intravenous diuretic for heart failure without hospitalization.

）是一项随机、安慰剂对照、平行组、多中心、双盲的三期临床研究，评估了VERQUVO与安慰剂在慢性心力衰竭伴射血分数降低（HFrEF）病情恶化的患者中的效果。这些患者在失代偿事件后，同时接受现有的心力衰竭治疗。失代偿事件定义为因心力衰竭住院或未住院情况下接受静脉注射利尿剂治疗的心力衰竭。

The primary endpoint of the study was the composite of time to first occurrence of cardiovascular death or heart failure hospitalization. Secondary endpoints included time to occurrence of cardiovascular death, time to first occurrence of heart failure hospitalization, time to total heart failure hospitalizations (including first and recurrent events), time to the composite of all-cause mortality or heart failure hospitalization, and time to all-cause mortality.

研究的主要终点是心血管死亡或心力衰竭住院首次发生的时间的复合终点。次要终点包括心血管死亡发生的时间、心力衰竭住院首次发生的时间、总心力衰竭住院时间（包括首次和复发事件）、全因死亡率或心力衰竭住院的复合终点时间，以及全因死亡时间。

The study enrolled 5,050 patients who were randomized to receive either VERQUVO once daily (titrated up to 10 mg) or placebo when given in combination with available heart failure therapies. The study, which was co-sponsored by Merck and Bayer, was conducted in collaboration with the Canadian VIGOUR Centre and the Duke Clinical Research Institute in more than 600 centers in 42 countries..

该研究招募了5050名患者，他们被随机分配每天一次接受VERQUVO（剂量调整至10毫克）或安慰剂，同时联合现有的心力衰竭疗法。这项研究由默克和拜耳共同赞助，与加拿大VIGOUR中心和杜克临床研究所合作，在42个国家的600多个中心进行。

About VERQUVO

关于VERQUVO

VERQUVO is an oral once daily stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling.

VERQUVO 是一种口服的每日一次可溶性鸟苷酸环化酶（sGC）刺激剂，sGC 是一氧化氮（NO）信号通路中的重要酶。当 NO 与 sGC 结合时，该酶会催化细胞内环鸟苷酸单磷酸（cGMP）的合成，cGMP 是一种在血管张力、心肌收缩力和心脏重塑调节中起作用的第二信使。

Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction. By directly stimulating sGC, independently of and synergistically with NO, VERQUVO augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation..

心力衰竭与一氧化氮（NO）合成受损和可溶性鸟苷酸环化酶（sGC）活性降低有关，这可能导致心肌和血管功能障碍。VERQUVO通过直接刺激sGC，独立于并协同于NO，增加细胞内环磷酸鸟苷（cGMP）水平，从而导致平滑肌松弛和血管扩张。

VERQUVO is FDA-approved to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for HF or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.

VERQUVO 获得 FDA 批准，用于降低成人慢性心力衰竭（HF）患者在因 HF 住院或需要门诊静脉注射利尿剂后，发生心血管死亡和心力衰竭（HF）住院的风险，适用于有症状的慢性 HF 且射血分数小于 45% 的患者。

Selected Safety Information for VERQUVO (vericiguat) tablets (2.5 mg, 5 mg, and 10 mg)

VERQUVO（维利西胍）片剂（2.5毫克、5毫克和10毫克）的精选安全信息

About the Worldwide Collaboration between Merck and Bayer

关于默克和拜耳之间的全球合作

Since October 2014, Bayer and Merck (known as MSD outside the U.S. and Canada) have pursued a worldwide collaboration in the field of sGC modulators. The collaboration brings together two leading companies that have stated their intent to fully evaluate this therapeutic class in areas of unmet medical need.

自2014年10月以来，拜耳和默克（在美国和加拿大以外地区称为MSD）在全球范围内展开了关于sGC调节剂的合作。此次合作汇集了两家领先公司，它们表示有意在未满足医疗需求的领域全面评估这一治疗类别。

The vericiguat program is being co-developed by Bayer and MSD. MSD has the commercial rights to vericiguat in the U.S. and Bayer has the exclusive commercial rights in the rest of world. The companies share equally the costs of the development of vericiguat..

维立西呱项目由拜耳和默克公司共同开发。默克公司拥有维立西呱在美国的商业权利，而拜耳则在世界其他地区拥有独家商业权利。两家公司平分维立西呱的开发成本。

About Merck

关于默克

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines.

在默克（美国和加拿大以外地区称为MSD），我们围绕一个使命团结一致：我们利用前沿科学的力量，拯救生命并改善世界各地人们的生活。130多年来，我们通过研发重要药物和疫苗，为人类带来了希望。

We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

我们立志成为全球首屈一指的研究密集型生物制药公司——今天，我们站在研究的最前沿，提供创新的健康解决方案，推动人类和动物疾病预防与治疗的进步。我们培养多元化和包容性的全球员工队伍，并每天负责任地运营，以确保为所有人和社区创造一个安全、可持续和健康的未来。