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Cited by 9Diabetes Treatment and ManagementDiabetes, Cardiovascular Risks, and LipoproteinsHeart Failure Treatment and Management

Effects of oral semaglutide on cardiovascular outcomes: A systematic review and meta-analysis

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Rebelo, Thiago Gorayeb, de Araujo Paysano, Maria Lúcia Brito, Matheus, Gustavo Tadeu Freitas Uchôa, Ribeiro, Danilo Monteiro, Said, Thomas Benevides, Kelly, Francinny Alves·2025·International Journal of Cardiology
DOI 10.1016/j.ijcard.2025.133683
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Abstract

Background Cardiovascular disease remains a leading cause of morbidity and mortality in type 2 diabetic mellitus (T2DM) patients. While injectable GLP-1 RAs have demonstrated efficacy in reducing cardiovascular risk, an oral formulation of semaglutide was developed to improve accessibility and treatment adherence, however, its therapeutic potential has yet to be fully elucidated. This meta-analysis evaluates the efficacy of oral semaglutide on cardiovascular outcomes to better inform clinical decision-making. Methods A systematic search was conducted in major databases for randomized controlled trials (RCTs) up to May 2025, with a primary outcome of cardiovascular events, expanded outcomes included nonfatal stroke, death from cardiovascular cause, and nonfatal myocardial infarction, and the secondary outcome was all-cause mortality. Statistical analysis was performed using RStudio, with heterogeneity assessed via I 2 statistics. Results A total of 13,875 patients were included, of whom 6935 received oral semaglutide and 6940 received placebo from the 5 eligible studies. A significant difference was observed for cardiovascular events with a risk ratio (RR) of 0.86 (95 % CI: 0.78–0.95; p = 0.0029; I 2 = 0 %) and hazard ratio (HR) of 0.85 (95 % CI: 0.77–0.95), respectively. In contrast, no significant difference was found for nonfatal stroke, all-cause mortality, death from cardiovascular causes, and nonfatal myocardial infarction. Conclusion The meta-analysis revealed that oral semaglutide was cardioprotective in T2DM patients with consistent reductions in cardiovascular event risk. However, the lack of significance in the remaining outcomes underscores the need for further investigation.

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Authors
Rebelo, T. G., de Araujo Paysano, M. L. B., Matheus, G. T. F. U., Ribeiro, D. M., Said, T. B., & Kelly, F. A.
Affiliations
  • University of Ottawa (CA)
  • Universidade Federal do Triângulo Mineiro (BR)
  • Anhembi Morumbi University (BR)
  • Universidade Federal do Amazonas (BR)
  • Instituto Dante Pazzanese de Cardiologia (BR)
Corresponding author
Rebelo, Thiago Gorayeb
ORCID
Venue
International Journal of Cardiology
Publisher
Elsevier BV
Published
2025-12
Volume
440
Pages
133683
ISSN
0167-5273 (ISSN-L)
DOI
10.1016/j.ijcard.2025.133683
OpenAlex
W4412791569
Cited by
9
References
19
Citations by year
2026: 6 · 2025: 3
FWCI
1.24
Type
journal article
Language
en
Open access
Licence
Locations
  • International Journal of Cardiology (publishedVersion, cc-by)
  • PubMed (publishedVersion)
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 › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
Keywords
oral semaglutide, cardiovascular outcomes, type 2 diabetes, GLP-1 receptor agonists, cardiovascular events, myocardial infarction, stroke, all-cause mortality, cardiovascular mortality, cardioprotection
MeSH terms
Semaglutide, Administration, Oral, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Glucagon-Like Peptides, Humans, Hypoglycemic Agents, Randomized Controlled Trials as Topic, Treatment Outcome, Glucagon-Like Peptide 1

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