{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T03:39:54Z","timestamp":1785901194487,"version":"3.56.0"},"reference-count":31,"publisher":"The Endocrine Society","license":[{"start":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T00:00:00Z","timestamp":1784592000000},"content-version":"am","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Novo Nordisk A\/S"},{"DOI":"10.13039\/501100004191","name":"Novo Nordisk","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004191","id-type":"DOI","asserted-by":"publisher"}]},{"name":"SOUL Steering Committee"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Context<\/jats:title>\n                    <jats:p>In the SOUL trial (NCT03914326), oral semaglutide reduced risk of major adverse cardiovascular (CV) events (MACE) by 14%. Whether baseline or changes in HbA1c or BMI are associated with these CV benefits is not known.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>We evaluated whether CV benefits of oral semaglutide are associated with baseline or in-trial reductions in HbA1c or BMI.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Post hoc analysis of SOUL, a double-blind, placebo-controlled trial (2019-2024).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>International, 444 sites.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Adults aged \u226550 years, with type 2 diabetes and atherosclerotic CV disease and\/or chronic kidney disease.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention(s)<\/jats:title>\n                    <jats:p>Oral semaglutide or placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcome measures<\/jats:title>\n                    <jats:p>Three-point MACE (CV death, nonfatal myocardial infarction, or nonfatal stroke) analyzed by baseline and in-trial changes in HbA1c and BMI (weeks 13; 52).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 9650 adults randomized 1:1 to oral semaglutide or placebo were followed for 47.5 months. Median (IQR) age was 66 (61-72) years, mean (\u00b1SD) HbA1c 8.0 (1.1)% (63.5 \u00b1 12.5\u2005mmol\/mol) and BMI 31.1 (5.8) kg\/m2. MACE benefits from oral semaglutide were significantly different across baseline HbA1c categories (P-interaction = .04), suggesting greater risk reduction at higher baseline HbA1c, but were consistent across baseline BMI categories. Greater in-trial HbA1c reductions were associated with larger decreases in MACE risk with oral semaglutide at 13 and 52 weeks (P-interactions = .005 and &amp;lt; .001, respectively), whereas BMI changes showed consistency (P-interactions = .88 and .64, respectively).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In SOUL, CV benefits of oral semaglutide appeared more pronounced among participants with higher baseline HbA1c and greater HbA1c reductions, but were consistent across baseline or changes in BMI.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1210\/clinem\/dgag290","type":"journal-article","created":{"date-parts":[[2026,7,18]],"date-time":"2026-07-18T11:40:21Z","timestamp":1784374821000},"source":"Crossref","is-referenced-by-count":1,"title":["Oral semaglutide and CV benefits in the SOUL trial: how do baseline or changes in HbA1c and BMI affect clinical outcomes?"],"prefix":"10.1210","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1254-6636","authenticated-orcid":false,"given":"Silvio E","family":"Inzucchi","sequence":"first","affiliation":[{"name":"Section of Endocrinology, Yale University School of Medicine , New Haven, CT 06520-8020 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3520-8472","authenticated-orcid":false,"given":"Rohana","family":"Abdul Ghani","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, Universiti Teknologi MARA (UiTM) , Shah Alam, Selangor 47000 ,","place":["Malaysia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Deanfield","sequence":"additional","affiliation":[{"name":"Institute of Cardiovascular Sciences, University College London , London WC1E 6DD ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott","family":"Emerson","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, University of Washington , Seattle, WA 98195 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mads D M","family":"Engelmann","sequence":"additional","affiliation":[{"name":"Medical & Translational Science, Novo Nordisk A\/S , S\u00f8borg 2860 ,","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8145-1676","authenticated-orcid":false,"given":"G Kees","family":"Hovingh","sequence":"additional","affiliation":[{"name":"Medical & Translational Science, Novo Nordisk A\/S , S\u00f8borg 2860 ,","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ole K","family":"Jeppesen","sequence":"additional","affiliation":[{"name":"Medical & Translational Science, Novo Nordisk A\/S , S\u00f8borg 2860 ,","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monika","family":"Kellerer","sequence":"additional","affiliation":[{"name":"Center for Internal Medicine I, Marienhospital Stuttgart , Stuttgart 70199 ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kabirdev","family":"Mandavya","sequence":"additional","affiliation":[{"name":"Medical Affairs, Novo Nordisk Service Centre India Pvt Ltd , Bangalore 560 066 ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johannes F","family":"Mann","sequence":"additional","affiliation":[{"name":"Department of Nephrology & Hypertension, Friedrich Alexander University of Erlangen , Erlangen 91054 ,","place":["Germany"]},{"name":"KfH Kidney Center , Munich 80804 ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6141-634X","authenticated-orcid":false,"given":"Nikolaus","family":"Marx","sequence":"additional","affiliation":[{"name":"Clinic for Cardiology, Angiology, and Intensive Care Medicine, RWTH Aachen University, University Hospital Aachen , Aachen 52074 ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chantal","family":"Mathieu","sequence":"additional","affiliation":[{"name":"Clinical and Experimental Endocrinology, UZ Leuven , Leuven 3000 ,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darren K","family":"McGuire","sequence":"additional","affiliation":[{"name":"Clinic for Cardiology, Angiology, and Intensive Care Medicine, University of Texas Southwestern Medical Center , Dallas, TX 75390 ,","place":["USA"]},{"name":"Internal Medicine\/Cardiology, Parkland Health System , Dallas, TX 75235 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5038-6210","authenticated-orcid":false,"given":"Viswanathan","family":"Mohan","sequence":"additional","affiliation":[{"name":"Madras Diabetes Research Foundation (ICMR Collaborating Centre of Excellence) , Chennai 603103 ,","place":["India"]},{"name":"Dr Mohan's Diabetes Specialties Centre (IDF Centre of Excellence in Diabetes) , Chennai 600086 ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharon L","family":"Mulvagh","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Cardiology, Dalhousie University , Halifax, NS B3H 4R2 ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodica","family":"Pop-Busui","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Diabetes and Clinical Nutrition, Oregon Health & Science University , Portland, OR 97239 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neil R","family":"Poulter","sequence":"additional","affiliation":[{"name":"Imperial Clinical Trials Unit, School of Public Health, Imperial College London , London SW7 2AZ ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1269-3580","authenticated-orcid":false,"given":"Neda","family":"Rasouli","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Metabolism and Diabetes, University of Colorado School of Medicine , Aurora, CO 80045 ,","place":["USA"]},{"name":"Research Service, VA Eastern Colorado Health Care , Aurora, CO 80012 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Sejersten Ripa","sequence":"additional","affiliation":[{"name":"Medical & Translational Science, Novo Nordisk A\/S , S\u00f8borg 2860 ,","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriela","family":"Roman","sequence":"additional","affiliation":[{"name":"Department of Diabetes, Nutrition and Metabolic Diseases, Iuliu Hatieganu University of Medicine and Pharmacy , Cluj-Napoca 400347 ,","place":["Romania"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R\u00f3binson","family":"S\u00e1nchez Garc\u00eda","sequence":"additional","affiliation":[{"name":"Clinical Cardiology, Cardiovascular Foundation of Colombia , Bucaramanga 681011 ,","place":["Colombia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Shechter","sequence":"additional","affiliation":[{"name":"The Leviev Cardiothoracic & Vascular Center, Sheba Medical Center , Ramat Gan 5265601 ,","place":["Israel"]},{"name":"Faculty of Medicine, Tel Aviv University , Tel Aviv-Yafo 6997801 ,","place":["Israel"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John B","family":"Buse","sequence":"additional","affiliation":[{"name":"Division of Endocrinology and Metabolism, University of North Carolina School of Medicine , Chapel Hill, NC 27514 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"80","published-online":{"date-parts":[[2026,7,21]]},"reference":[{"issue":"Suppl 1","key":"2026080411511496700_dgag290-B1","doi-asserted-by":"crossref","first-page":"S183","DOI":"10.2337\/dc26-S009","article-title":"9. 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