e full results from the SOUL cardiovascular outcomes trial, investigating the effects of Rybelsus (semaglutide) tablets 14 mg on reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and ASCVD and/or CKD, achieved its primary endpoint demonstrating a 14% reduction in risk of MACE (2% absolute risk reduction at 3 years) compared to placebo (579 vs 668 events; hazard ratio: 0.86 [0.77; 0.96]; p=0.0055).
SOUL is a randomised, double-blind, parallel-group, placebo-controlled, event-driven CV outcomes trial which enrolled 9,650 adults with type 2 diabetes and ASCVD and/or CKD. The primary endpoint was time from randomisation to first occurrence of a major adverse CV event (a composite of CV death, nonfatal myocardial infarction or nonfatal stroke).
The overall safety profile of oral semaglutide 14 mg in SOUL was consistent with that seen in previous trials, and no new safety signals were observed. The incidence of serious adverse events (SAEs) was lower in participants receiving oral semaglutide 14 mg than those receiving placebo, mostly due to the higher rate of cardiovascular events and infections in the placebo group. The most common SAEs were cardiac disorders (17.8% and 19.8%, respectively) and infections/infestations (15.0% and 16.5%, respectively).
Serious adverse events were less common with oral semaglutide 14 mg (47.9%) than with placebo (50.3%), although there was a higher incidence of gastrointestinal disorders with oral semaglutide 14 mg (5.0% versus 4.4%). Adverse events leading to permanent treatment discontinuation were more common for oral semaglutide 14 mg than placebo (749 [15.5%] and 559 [11.6%], respectively), comprising mainly gastrointestinal disorders in both arms (310 [6.4%] and 98 [2.0%], respectively). Additionally, the placebo group had 96 cases (2.0%) of infections and infestations leading to treatment discontinuation (versus 63 [1.3%] with oral semaglutide 14 mg).
Based on data from the SOUL clinical trial, Novo Nordisk submitted a label extension application for Rybelsus (semaglutide) tablets 14 mg which has been accepted for review by the FDA. A decision is anticipated in 2025.
The key objective of the SOUL trial was to demonstrate that oral semaglutide 14 mg helps lower 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 patients with type 2 diabetes and ASCVD and/or CKD.
"The significant reduction in risk of composite endpoint of heart attack, stroke, or death seen in the SOUL trial in adults with type 2 diabetes highlights the cardiovascular impact of oral semaglutide in adult patients with cardiometabolic conditions such as type 2 diabetes and atherosclerotic cardiovascular disease and/or chronic kidney disease," said Dr John B Buse, Distinguished Professor of Medicine, Director of UNC Diabetes Care Center, Steering Committee Co-Chair of the SOUL trial. "Given the cardiovascular outcomes seen in SOUL, the trial represents important data for a community who may need options that also address common and serious comorbidities of type 2 diabetes, like cardiovascular disease."
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