Semaglutide & Heart Health: SOUL Trial Results
- Chicago-The SOUL trial revealed that oral semaglutide considerably reduces major adverse cardiovascular events (MACE) by 14% in patients with type 2 diabetes (T2D) and high cardiovascular (CV) risk.
- The study, a double-blind, placebo-controlled phase 3b trial, demonstrated that the oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) lowered the risk of cardiovascular death, nonfatal myocardial infarction, and...
- McGuire, professor of medicine at UT Southwestern Medical Center and lead author, stated in a news release that addressing comorbidities like heart disease is crucial when treating patients...
Oral semaglutide demonstrates meaningful cardiovascular benefits, slashing major adverse cardiovascular events (MACE) by 14% in type 2 diabetes patients at high cardiovascular risk, according to the SOUL trial findings. This groundbreaking research, presented at the ADA Scientific Sessions, highlights oral semaglutide‘s potential as a vital treatment option and its accessibility compared to injectables.The study revealed that benefits persist irrespective of SGLT2i use, bolstering confidence in combining therapies. News Directory 3 provides comprehensive coverage of these impactful developments. Explore the implications for stroke prevention and optimal A1C goals. Discover what’s next …
Oral Semaglutide Shows Cardiovascular Benefits in Type 2 Diabetes Patients
Updated June 23, 2025
Chicago-The SOUL trial revealed that oral semaglutide considerably reduces major adverse cardiovascular events (MACE) by 14% in patients with type 2 diabetes (T2D) and high cardiovascular (CV) risk. The findings were presented at the American Diabetes Association (ADA) 85th Scientific Sessions.
The study, a double-blind, placebo-controlled phase 3b trial, demonstrated that the oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) lowered the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke across diverse patient populations.The research highlights the potential of oral semaglutide as a valuable treatment option for managing both diabetes and cardiovascular risk.
Darren K. McGuire, professor of medicine at UT Southwestern Medical Center and lead author, stated in a news release that addressing comorbidities like heart disease is crucial when treating patients with type 2 diabetes. He added that the findings suggest oral semaglutide is a promising option for managing both diabetes and cardiovascular risk.
An expert panel, including McGuire, Rodica Pop-busui, Nikolaus Marx, John B. Buse, Silvio E. Inzucchi, and John Deanfield, discussed the trial results. They proposed that oral semaglutide could be a more accessible choice to injectable GLP-1 receptor agonists for many patients.
The SOUL trial enrolled 9,650 individuals aged 50 and older with an A1C level between 6.5% and 10%. Participants were randomly assigned to receive once-daily oral semaglutide or a placebo, in addition to standard care.
Initial results showed MACE occured in 579 of 4,825 individuals in the semaglutide group, compared to 668 of 4,825 in the placebo group, yielding a hazard ratio of 0.86. While secondary outcomes did not show statistically notable differences, serious adverse events were slightly less frequent in the semaglutide group (47.9%) compared to the placebo group (50.3%).
Nikolaus Marx noted that oral semaglutide reduced MACE outcomes regardless of concomitant sodium-glucose cotransporter-2 inhibitor (SGLT2i) treatment.The safety profiles were similar with or without SGLT2i use.
“These findings provide clinicians further confidence to combine GLP-1 receptor agonists and SGLT2i with the aim of reducing cardiovascular events in this high-risk population,” Marx concluded.
Stroke outcomes, presented by Silvio E. Inzucchi, indicated that while oral semaglutide reduced MACE, the reduction in stroke alone was not statistically significant.However, he suggested that younger patients and those without hypertension might benefit from semaglutide for stroke prevention.
What’s next
Experts at the ADA meeting emphasized the importance of translating the SOUL trial findings into real-world clinical practice to improve care for high-risk patients with type 2 diabetes.Further research will explore optimal A1C thresholds for GLP-1 receptor agonist use.