Rybelsus® (semaglutide tablets, 14mg) reduced the risk of major adverse cardiovascular events in adults with type 2 diabetes and cardiovascular disease and/or chronic kidney disease.
Novo Nordisk presented the full results from the SOUL cardiovascular outcomes trial during a late-breaking clinical trial session at the American College of Cardiology’s (ACC) Annual Scientific Session and Expo in Chicago, US.
The SOUL trial achieved its primary endpoint, demonstrating a 14 per cent reduction (hazard ratio 0.86 (95 per cent CI, 0.77-0.96) (p value = 0.006)) in risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and cardiovascular disease (CVD) and/or chronic kidney disease (CKD) when treated with semaglutide tablets at 14mg, compared to placebo (n:579 vs 668 for semaglutide and placebo, respectively).
Each component of MACE (CV death, nonfatal myocardial infarction and nonfatal stroke) contributed to the risk reduction (at three years (pre-specified analysis) the Absolute Risk Reduction (ARR) was two per cent, and Numbers Needed to Treat (NNT) 50 persons (95 per cent CI 31-125)).
Cardiometabolic diseases span a wide range of conditions, including type 2 diabetes and kidney disease, with cardiovascular diseases representing the leading cause of death globally.
Having type 2 diabetes directly increases the risk of developing associated cardiometabolic diseases, while also contributing to the progression of other cardiovascular risk factors. Nearly one in three adults living with type 2 diabetes also live with cardiovascular disease.
“I welcome these full results presented at ACC, which share new details concerning the trialled efficacy and safety profile of semaglutide tablets in people living with type 2 diabetes and established cardiovascular or chronic kidney disease. Cardiovascular disease is a significant health challenge for many people living with type 2 diabetes, and these data provide meaningful scientific insights in this area of unmet need,” said Steve Bain, Assistant Medical Director for Research & Development for Swansea Bay University Health Board and Clinical Director of the Diabetes Research Unit in Swansea University.
The overall safety profile of semaglutide tablets, 14mg in SOUL was consistent with that seen in previous semaglutide trials, and no new safety signals were observed. The incidence of serious adverse events (SAEs) was lower in participants receiving semaglutide tablets than those receiving placebo, with a higher rate of cardiovascular events and infections observed in the placebo group. The most common SAEs were cardiac disorders (17.8 per cent and 19.8 per cent, respectively) and infections/infestations (15.0 per centand 16.5 per cent, respectively) in the semaglutide tablet, and placebo arms.
Based on data from the SOUL clinical trial, Novo Nordisk submitted a label extension application for Rybelsus®, which has been accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). A decision is anticipated in 2025.
SOUL was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase three cardiovascular outcomes trial with 9,650 people enrolled.
It was conducted to assess the effect of semaglutide tablets vs placebo on cardiovascular outcomes in people with type 2 diabetes and established CVD and/or CKD.
The key objective of SOUL was to investigate whether 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 people with type 2 diabetes and established CVD and/or CKD.
In the UK Rybelsus® (semaglutide tablets) is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise
- As monotherapy when metformin is considered inappropriate due to intolerance or contraindications
- In combination with other medicinal products for the treatment of diabetes.
Photo by James Yarema on Unsplash
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