Article detail · 2025
Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes
- Year
- 2025
- Type
- article
Data source split
- YÖKSİS YÖKSİS article record
- YÖKSİS venue New England Journal of Medicine
- Catalog match (ISSN) New England Journal of Medicine
- OpenAlex OpenAlex enrichment (abstract, citations, topics)
Abstract
OpenAlex · English
BACKGROUND: The cardiovascular safety of oral semaglutide, a glucagon-like peptide 1 receptor agonist, has been established in persons with type 2 diabetes and high cardiovascular risk. An assessment of the cardiovascular efficacy of oral semaglutide in persons with type 2 diabetes and atherosclerotic cardiovascular disease, chronic kidney disease, or both is needed. METHODS: In this double-blind, placebo-controlled, event-driven, superiority trial, we randomly assigned participants who were 50 years of age or older, had type 2 diabetes with a glycated hemoglobin level of 6.5 to 10.0%, and had known atherosclerotic cardiovascular disease, chronic kidney disease, or both to receive either once-daily oral semaglutide (maximal dose, 14 mg) or placebo, in addition to standard care. The primary outcome was major adverse cardiovascular events (a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke), assessed in a time-to-first-event analysis. The confirmatory secondary outcomes included major kidney disease events (a five-point composite outcome). RESULTS: Among the 9650 participants who had undergone randomization, the mean (±SD) follow-up was 47.5±10.9 months, and the median follow-up was 49.5 months. A primary-outcome event occurred in 579 of the 4825 participants (12.0%; incidence, 3.1 events per 100 person-years) in the oral semaglutide group, as compared with 668 of the 4825 participants (13.8%; incidence, 3.7 events per 100 person-years) in the placebo group (hazard ratio, 0.86; 95% confidence interval, 0.77 to 0.96; P = 0.006). The results for the confirmatory secondary outcomes did not differ significantly between the two groups. The incidence of serious adverse events was 47.9% in the oral semaglutide group and 50.3% in the placebo group; the incidence of gastrointestinal disorders was 5.0% and 4.4%, respectively. CONCLUSIONS: Among persons with type 2 diabetes and atherosclerotic cardiovascular disease, chronic kidney disease, or both, the use of oral semaglutide was associated with a significantly lower risk of major adverse cardiovascular events than placebo, without an increase in the incidence of serious adverse events. (Funded by Novo Nordisk; SOUL ClinicalTrials.gov number, NCT03914326.).
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369 citations
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10 publications in the local catalog that cite this work (OpenAlex reference match; not the full global list).
- Oral Semaglutide and Heart Failure Outcomes in Persons With Type 2 Diabetes 2026
- Oral Semaglutide and Heart Failure Outcomes in Persons With Type 2 Diabetes 2026
- Oral Semaglutide and Heart Failure Outcomes in Persons With Type 2 Diabetes 2026
- Impact of Oral Semaglutide on Kidney Outcomes in People With Type 2 Diabetes: Results From the SOUL Randomized Trial 2025
- Potential of the FOX gene family and LncRNAs as biomarkers in differentiated thyroid cancer treated with I-131 2025
- Oral Semaglutide and Change in Cardiovascular Risk Factors in High-Risk Type 2 Diabetes 2026
- Oral Semaglutide and Change in Cardiovascular Risk Factors in High-Risk Type 2 Diabetes 2026
- Oral Semaglutide and Change in Cardiovascular Risk Factors in High-Risk Type 2 Diabetes 2026
- CVOT Summit Report 2025: advances along the cardiovascular–kidney–metabolic disease continuum 2026
- Disease-modifying anti-diabetic drugs (DMADDs): bridging the SIMPLE approach to disease interception 2026