Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes
Open accessAbstract
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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The SOUL trial demonstrated a significant reduction in MACE compared to placebo among individuals with type 2 diabetes and high cardiovascular or renal risk.
“Cardiovascular safety was first established in the PIONEER 6 trial,98 with the more recent SOUL trial demonstrating a significant reduction in MACE compared to placebo among individuals with type 2 diabetes and high cardiovascular or renal risk.99”
From The expanding role of GLP-1 receptor agonists: a narrative review of current evidence and future directions (2025) · cites this paper as [99]
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SGLT2 inhibitors and the risk of hepatocellular carcinoma in patients with MASLD and Type 2 diabetes
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Pharmacologic Therapies for Type 2 Diabetes
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- Authors
- McGuire, D. K., Marx, N., Mulvagh, S. L., Deanfield, J. E., Inzucchi, S. E., Pop-Busui, R., Mann, J. F. E., Emerson, S. S., Poulter, N. R., Engelmann, M. D. M., Ripa, M. S., Hovingh, G. K., Brown-Frandsen, K., Bain, S. C., Cavender, M. A., Gislum, M., David, J.-P., & Buse, J. B.
- Affiliations
- Parkland Health & Hospital System (US)
- Universitätsklinikum Aachen (DE)
- Dalhousie University (CA)
- University College London (GB)
- Yale University (US)
- Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland
- Friedrich-Alexander-Universität Erlangen-Nürnberg (DE)
- University of Washington (US)
- Imperial College London (GB)
- Novo Nordisk (Denmark) (DK)
- Novo Nordisk, Søborg, Denmark
- Swansea University (GB)
- University of North Carolina at Chapel Hill (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2025-05-29
- Volume
- 392
- Issue
- 20
- Pages
- 2001-2012
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4408960945
- Cited by
- 416
- References
- 23
- Citations by year
- 2026: 263 · 2025: 153
- FWCI
- 283.71
- Type
- journal article
- Language
- en
- Open access
- green
- pure.amsterdamumc.nl
- Licence
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, other-oa)
- RWTH Publications (RWTH Aachen) (submittedVersion)
- Funders
- Novo Nordisk (n/a)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- oral semaglutide, type 2 diabetes, major adverse cardiovascular events, atherosclerotic cardiovascular disease, chronic kidney disease, GLP-1 receptor agonists, cardiovascular safety, kidney disease progression, serious adverse events, gastrointestinal adverse effects, older adults, HbA1c, myocardial infarction, stroke, cardiovascular mortality
- MeSH terms
- Glucagon-Like Peptide-1 Receptor Agonists, Semaglutide, Administration, Oral, Aged, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Follow-Up Studies, Glycated Hemoglobin, Humans, Male, Middle Aged, Atherosclerosis, Renal Insufficiency, Chronic, Glucagon-Like Peptide 1
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