Novo Nordisk announced the headline results from the SOUL cardiovascular outcomes trial. The double-blinded, randomised trial compared oral semaglutide to placebo as an adjunct to standard of care for the prevention of major adverse cardiovascular events (MACE)

诺和诺德宣布了SOUR心血管结局试验的主要结果。

The trial enrolled 9,650 people with type 2 diabetes and established cardiovascular disease (CVD) and/or chronic kidney disease (CKD). As part of standard of care, 49% of patients received SGLT2i at some point during the trial.

该试验招募了9650名2型糖尿病患者，并确定了心血管疾病（CVD）和/或慢性肾病（CKD）。作为护理标准的一部分，49%的患者在试验期间的某个时候接受了SGLT2i。

The trial achieved its primary objective by demonstrating a statistically significant and superior reduction in MACE of 14% for people treated with oral semaglutide compared to placebo (Based on treatment policy estimand): treatment effect regardless of treatment adherence). The primary endpoint of the study was defined as the composite outcome of the first occurrence of MACE defined as cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.

该试验实现了其主要目标，证明与安慰剂相比，口服semaglutide治疗的患者MACE的统计学显着性和优越性降低了14%（基于治疗政策估计）：无论治疗依从性如何，治疗效果都是如此。该研究的主要终点定义为首次发生MACE的综合结果，定义为心血管死亡，非致命性心肌梗死或非致命性中风。

All three components of the primary endpoint contributed to the superior MACE reduction demonstrated by oral semaglutide..

主要终点的所有三个成分都有助于口服semaglutide证明MACE的优越减少。。

In the trial, oral semaglutide appeared to have a safe and well-tolerated profile in line with previous oral semaglutide trials.

在试验中，口服semaglutide似乎具有安全且耐受性良好的特征，与之前的口服semaglutide试验一致。

'We are pleased to see that the results from SOUL demonstrate that oral semaglutide reduces the risk of cardiovascular events and that the benefits of oral semaglutide come on top of standard of care,” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. “Approximately one in three adults with type 2 diabetes also have cardiovascular disease; therefore, it is crucial to have therapies that can address both conditions.”.

诺和诺德执行副总裁兼开发主管马丁·霍尔斯特·兰格（Martin Holst Lange）说：“我们很高兴看到，Soull的研究结果表明，口服semaglutide可以降低心血管事件的风险，口服semaglutide的益处优于标准护理。”。“大约三分之一的2型糖尿病成年人也患有心血管疾病；因此，至关重要的是要有能够解决这两种情况的疗法。”。

Novo Nordisk expects to file for regulatory approval of a label expansion for Rybelsus in both the US and EU around the turn of the year. The detailed results from SOUL will be presented at a scientific conference in 2025.

诺和诺德预计将于今年年初左右在美国和欧盟申请监管部门批准Rybelsus的标签扩展。。

About the SOUL trialSOUL was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase 3 cardiovascular outcomes trial with 9,650 people enrolled. It was conducted to assess the effect of oral semaglutide vs placebo on cardiovascular outcomes in people with type 2 diabetes and established CVD and/or CKD.

关于SOUR试验SOUL是一项多中心，国际性，随机，双盲，平行组，安慰剂对照，3期心血管结局试验，共有9650人参加。研究旨在评估口服semaglutide与安慰剂对2型糖尿病患者心血管结局的影响，并确定CVD和/或CKD。

The SOUL trial was initiated in 2019..

灵魂审判于2019年开始。。

The key objective of SOUL was to demonstrate that oral semaglutide lowers the risk of major adverse cardiovascular events (a composite endpoint consisting of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke) compared to placebo, both added to standard of care in patients with type 2 diabetes and established CVD and/or CKD..

SOUR的关键目标是证明，与安慰剂相比，口服semaglutide可降低主要不良心血管事件（由心血管死亡，非致命性心肌梗死和非致命性中风组成的复合终点）的风险，这两种药物均被添加到2型糖尿病患者的护理标准中，并已建立CVD和/或CKD。。

Condition: Diabetes Type 2 + CV Disease

病情：2型糖尿病+心血管疾病

Type: drug

类型：药物