《新英格兰医学杂志》重磅研究：口服司美格鲁肽为高风险2型糖尿病患者带来心血管福音

Core Viewpoint - The article discusses the significant cardiovascular benefits of oral semaglutide for high-risk type 2 diabetes patients, highlighting its potential to reduce major adverse cardiovascular events (MACE) and improve treatment adherence compared to injectable forms [4][5][15]. Summary by Sections Global Diabetes Statistics - Over 828 million people globally have diabetes, with more than 90% being type 2 diabetes patients, who face increased cardiovascular disease risks [4]. Clinical Research Overview - The SOUL study, published in the New England Journal of Medicine, involved a large-scale, international, multi-center, randomized controlled trial focusing on high-risk type 2 diabetes patients with a history of atherosclerotic cardiovascular disease or chronic kidney disease [4][7]. Study Design and Methodology - The study recruited 9,650 participants aged 50 and older with HbA1c levels between 6.5% and 10.0%, excluding those with end-stage renal disease [8]. - Participants were randomly assigned to receive either oral semaglutide (starting at 3 mg and increasing to 14 mg daily) or a placebo, with all patients receiving standard treatment [9][10]. Key Findings - Oral semaglutide significantly reduced the incidence of MACE: 12.0% in the treatment group compared to 13.8% in the control group [13]. - The study also reported a 26% reduction in non-fatal myocardial infarction risk and a 12% reduction in stroke risk [17]. Safety and Efficacy - The incidence of serious adverse events was lower in the treatment group (47.9% vs. 50.3%), while gastrointestinal reactions were slightly higher (5.0% vs. 4.4%) [14]. - The renal protective effect did not reach statistical significance, indicating a need for further research in patients with poorer baseline kidney function [15]. Implications for Treatment - The findings suggest that oral semaglutide could reshape diabetes treatment paradigms by providing a convenient oral option that maintains efficacy comparable to injectable forms, particularly in reducing non-fatal myocardial infarction risk [15]. - The study emphasizes the importance of further research to explore the drug's effects on renal outcomes in different patient populations [15].