SOUL Trial Shows 14% Reduction in Cardiovascular Events with Oral Semaglutide in Type 2 Diabetes
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The SOUL cardiovascular outcomes trial was a double-blinded, randomised trial that compared oral semaglutide to placebo as an adjunct to standard of care for the prevention of major adverse cardiovascular events (MACE). The trial enrolled 9,650 people with type 2 diabetes and established cardiovascular disease (CVD) and/or chronic kidney disease (CKD). As part of standard of care, 49% of patients received SGLT2i at some point during the trial.
The trial achieved its primary objective by demonstrating a statistically significant and superior reduction in major adverse cardiovascular events of 14% for people treated with oral semaglutide compared to placebo. The primary endpoint of the study was defined as the composite outcome of the first occurrence of major adverse cardiovascular events defined as cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. All three components of the primary endpoint contributed to the superior major adverse cardiovascular events reduction demonstrated by oral semaglutide.
In the trial, oral semaglutide appeared to have a safe and well-tolerated profile in line with previous oral semaglutide trials.
SOUL was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase 3 cardiovascular outcomes trial with 9,650 people enrolled. It was conducted to assess the effect of oral semaglutide vs placebo on cardiovascular outcomes in people with type 2 diabetes and established Cardiovascular disease and/or chronic kidney disease. The SOUL trial was initiated in 2019.
The key objective of SOUL was to demonstrate that 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 patients with type 2 diabetes and established Cardiovascular disease and/or chronic kidney disease.
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