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Topline results from the Semaglutide cardiOvascular oUtcomes triaL (SOUL) have been reported, showing that oral semaglutide, a long-acting Glucagon-Like Peptide-1 (GLP-1) receptor agonist, significantly reduces the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes (T2D) who have established atherosclerotic cardiovascular disease (ASCVD) and\/or chronic kidney disease (CKD).1<\/sup><\/span><\/p>\n The phase 3, randomized, double-blind, parallel-group, placebo-controlled cardiovascular outcomes trial (<\/span>NCT03914326)<\/span><\/a> enrolled 9,650 adults aged 50 years or older. Participants were randomly assigned to receive either 14 mg of oral semaglutide or a placebo, in addition to standard care. Over the course of the trial, which began in 2019 and completed in 2021, oral semaglutide demonstrated a 14% reduction in the risk of MACE compared to placebo. In this study, MACE included cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.2<\/sup><\/span><\/p>\n The study\u2019s primary outcome was the time from randomization to the first occurrence of MACE, with a target of 1,225 adjudication-confirmed events. The population was primarily male (71.1%) and predominantly White (68.9%), with a mean age of 66.1 years and a mean diabetes duration of 15.4 years. Participants had an average BMI of 31.3 kg\/m\u00b2 and an HbA1c of 63.5 mmol\/mol. At randomization, most patients had coronary artery disease (70.7%), with 42.3% having chronic kidney disease (CKD), 21.1% cerebrovascular disease and 15.7% symptomatic peripheral arterial disease (PAD). Prevalent heart failure was reported in 23% of participants. The majority of participants also had a history of hypertension and were taking at least one antihypertensive medication, with an average blood pressure of 135\/77 mmHg. Additionally, approximately 88% of participants were receiving LDL cholesterol-lowering treatments, and their LDL cholesterol levels were generally controlled, ranging from moderate to well.2<\/sup><\/span><\/p>\n These topline results will be followed by the full trial data, which are expected to be presented at a scientific congress in 2025. This presented data may not only add to a growing body of evidence supporting the cardiovascular efficacy of GLP-1 receptor agonists but also highlight the potential of an oral GLP-1RA in achieving these outcomes.<\/span><\/p>\n References:<\/b><\/p>\n GlobalNewswire. Novo Nordisk A\/S: Oral semaglutide demonstrates a 14% reduction in risk of major adverse cardiovascular events in adults with type 2 diabetes in the SOUL trial. 2024. [Press release]. Available at:<\/span> https:\/\/www.globenewswire.com\/news-release\/2024\/10\/21\/2965998\/0\/en\/Novo-Nordisk-A-S-Oral-semaglutide-demonstrates-a-14-reduction-in-risk-of-major-adverse-cardiovascular-events-in-adults-with-type-<\/span>2<\/span>-diabetes-in-the-SOUL-trial.html<\/span><\/a> (accessed 21 October 2024).<\/span><\/p>\n McGuire DK, Busui RP, Deanfield J, Inzucchi SE, Mann JFE, Marx N, Mulvagh SL, Poulter N, Engelmann MDM, Hovingh GK, Ripa MS, Gislum M, Brown-Frandsen K, Buse JB. <\/span>Effects of oral semaglutide on cardiovascular outcomes in individuals with type 2 diabetes and established atherosclerotic cardiovascular disease and\/or chronic kidney disease: Design and baseline characteristics of SOUL, a randomized trial.<\/span><\/a> Diabetes Obes Metab. 2023 Jul;25(7):1932-1941. doi: 10.1111\/dom<\/span><\/p>\n