SOUL Trial Journal Club
We break down evidence-based medicine so you don't have to! This journal club will discuss the new SOUL trial that is hot in the medical literature right now.
The New England Journal of Medicine published the SOUL trial in March 2025. This journal club post breaks down the SOUL trial and what change it may bring to our clinical practice.
Link to the trial on NEJM: https://www.nejm.org/doi/full/10.1056/NEJMoa2501006Background/Overview
Title: Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes
Citation: McGuire DK, Marx N, Mulvagh SL, et al. Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes. N Engl J Med. Mar 29, 2025; Online before publication
Gap in literature addressed: Cardiovascular efficacy has been established for injectable semaglutide in people with type 2 diabetes (T2DM) and cardiovascular disease (CVD) or high risk of CVD and in people with T2DM and chronic kidney disease (CKD). Only CV safety, not efficacy, has been established for oral semaglutide in people with T2DM and high risk of CVD
Objective: To assess the cardiovascular efficacy of oral semaglutide in persons with type 2 diabetes and established atherosclerotic cardiovascular disease, chronic kidney disease, or both
Primary Efficacy Measure: Major adverse cardiovascular events (a three-point composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke), assessed in an analysis of the time from randomization to the first event