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Publication Type: Journal article
Publication year: 2026
Book Volume: 11
Pages Range: 427-437
Journal Issue: 5
DOI: 10.1001/jamacardio.2026.0245
Importance: Individuals with type 2 diabetes (T2D) are at high risk of atherosclerotic cardiovascular disease (ASCVD). In the SOUL randomized clinical trial, once-daily oral semaglutide reduced risk of major adverse cardiovascular (CV) events by 14% vs placebo in people with T2D and ASCVD and/or chronic kidney disease (CKD) receiving standard of care (SoC); however, whether oral semaglutide modifies recognized CV risk factors in the long term is unclear. Objective: To investigate whether treatment with oral semaglutide was associated with changes in ASCVD risk factors vs placebo. Design, Setting, and Participants: This secondary analysis comprises post hoc intention-to-treat analyses of the SOUL (A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes) double-blind multicenter randomized clinical trial (randomization 1:1 to oral semaglutide or placebo) among adults with T2D and ASCVD and/or CKD receiving SoC. Participants underwent randomization from June 2019 to March 2021, with a mean (SD) of 47.5 (10.9) months of follow-up, and data were analyzed from February to December 2025. Intervention(s): Participants were treated with either once-daily oral semaglutide (maximum dose, 14 mg) or placebo, in addition to standard care. Main Outcomes and Measures: The primary outcome was the association of oral semaglutide vs placebo with glycated hemoglobin (HbA
APA:
Mulvagh, S.L., Inzucchi, S.E., Marx, N., Poulter, N.R., Deanfield, J.E., Pop-Busui, R.,... Murray, A.V. (2026). Oral Semaglutide and Change in Cardiovascular Risk Factors in High-Risk Type 2 Diabetes: A Post Hoc Secondary Analysis of the SOUL Randomized Clinical Trial. JAMA Cardiology, 11(5), 427-437. https://doi.org/10.1001/jamacardio.2026.0245
MLA:
Mulvagh, Sharon L., et al. "Oral Semaglutide and Change in Cardiovascular Risk Factors in High-Risk Type 2 Diabetes: A Post Hoc Secondary Analysis of the SOUL Randomized Clinical Trial." JAMA Cardiology 11.5 (2026): 427-437.
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