Novo Nordisk has released the full results of its landmark SOUL clinical trial, confirming that oral semaglutide not only helps manage blood sugar but also significantly reduces the risk of major cardiovascular events in people with type 2 diabetes who also suffer from heart or kidney disease. The findings were presented at the American College of Cardiology’s Annual Scientific Session in Chicago and published in The New England Journal of Medicine.

According to the trial data, oral semaglutide reduced the combined risk of heart attack, stroke, and death from heart-related causes by 14 per cent compared to a placebo. More specifically, the study reported a 26 per cent reduction in non-fatal heart attacks, a 12 per cent decrease in non-fatal strokes, and a 7 per cent drop in heart-related deaths. Notably, participants from Asian countries saw a 27 per cent overall reduction in cardiovascular risk, indicating even greater benefits in certain populations.

Experts from Dr Mohan’s Diabetes Specialities Centre hailed the results as a significant breakthrough. “This is a major step forward in treating people with type 2 diabetes. Oral semaglutide not only helps manage blood sugar but also protects the heart. This makes it an excellent choice for people with high heart risk,” they stated.

A key takeaway from the trial is that oral semaglutide proved effective regardless of whether participants were also taking other common diabetes medications such as SGLT2 inhibitors. This suggests that the drug can work in combination with existing treatments, offering a more holistic approach to diabetes care.

Experts at G D Hospital and Diabetes Institute in Kolkata echoed the sentiment, explaining that oral semaglutide should be considered earlier in the treatment plan for patients with high cardiovascular risk. “It is more than just a sugar-lowering medicine. It helps protect the heart too,” they said.

The safety profile of oral semaglutide remained consistent with previous studies. The medication showed no new safety concerns during the trial and has already been safely used worldwide, with clinical data representing over 33 million patient-years.

Novo Nordisk has filed for regulatory approval in both the U.S. and Europe to update the labelling of oral semaglutide to reflect its cardiovascular benefits. A decision is anticipated in 2025.

Company representatives stated that these results underscore Novo Nordisk’s commitment to addressing a wider spectrum of health issues related to metabolism and cardiovascular health. They believe oral semaglutide represents a major advancement in providing integrated care for patients with type 2 diabetes and heart disease.

With these findings, millions of people living with type 2 diabetes may soon have access to a single medicine that manages blood sugar while also lowering the risk of life-threatening heart complications.

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