Oral Semaglutide Reduces Risk of MACE for Patients With Type 2 Diabetes
Oral semaglutide had a safe and well-tolerated profile for individuals with type 2 diabetes, which is in line with those previously reported for the drug in other trials.
Oral semaglutide (Novo Nordisk) reduced the risk of major adverse cardiovascular events (MACE) for adults with type 2 diabetes, according to results from the SOUL (NCT03914326) trial. The double-blinded, randomized study compared oral semaglutide with placebo as an adjunct to the standard of care for MACE.1
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"We are pleased to see that the results from SOUL demonstrate that oral semaglutide reduces the risk of cardiovascular events and that the benefits of oral semaglutide come on top of standard of care,” Martin Holst Lange, executive vice president and head of Development at Novo Nordisk, said in a news release. “Approximately 1 in 3 adults with type 2 diabetes also have cardiovascular disease; therefore, it is crucial to have therapies that can address both conditions.”1
In the study, individuals took 1 tablet of either the placebo or oral semaglutide on an empty stomach and did not eat or drink anything for at least 30 minutes. The study lasted for 3.5 to 5 years, according to the clinical trial information. Individuals had 25 clinic visits and 1 phone call with the study physician throughout the study. Investigators included individuals with type 2 diabetes, hemoglobin A1c, aged 50 years or older at time of consent, and had at least 1 of the following conditions: coronary heart disease, cerebrovascular disease, symptomatic peripheral artery disease, or chronic kidney disease.2
The primary outcome included the time to first occurrence of MACE from week zero up to 61 months or more. The secondary outcome included time to first occurrence of a composite end point, time to occurrence of cardiovascular death, time toe first occurrence of major adverse lib events, time to first occurrence of an expanded MACE composite end point, time to first occurrence of a composite heart failure end point, and time to first occurrence of a composite chronic kidney disease end point.2
In the new analysis, there were 9650 individuals included who had with T2D and established cardiovascular disease and/or chronic kidney disease. The standard of care included 49% of individuals receiving a sodium-glucose cotransporter-2 (SGLT2) inhibitors.1
Investigators also reported that oral semaglutide had a safe and well-tolerated profile in line with those previously reported for the drug in other trials.1
In a previous report of the study, investigators reported the most frequently used antihyperglycaemic medication, including metformin, insulin and insulin analogues, sulphonylureas, SGLT2 inhibitors, and dipeptidyl peptidase-4 inhibitors. At randomization, 70.7% of individuals had coronary artery disease, 42.3% had chronic kidney disease, 21.1% had cerebrovascular disease, and 15.7% had symptomatic peripheral artery disease. The prevalence of heart failure was 23% among the participants.3
Investigators concluded that the study would provide evidence on the cardiovascular benefits of oral semaglutide for individuals with type 2 diabetes and atherosclerotic cardiovascular disease and/or chronic kidney disease.3
REFERENCES
1. 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. News release. Novo Nordisk. October 21, 2024. Accessed October 24, 2024. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=171480
2. A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes (SOUL). ClinicalTrials.gov identification: NCT03914326. Updated October 15, 2024. Accessed October 24, 2024. https://clinicaltrials.gov/study/NCT03914326
3. McGuire DK, Busui RP, Deanfield J, et al. 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. Diabetes Obes Metab. 2023;25(7):1932-1941. doi:10.1111/dom.15058
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