{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,10]],"date-time":"2026-01-10T00:46:53Z","timestamp":1768006013591,"version":"3.49.0"},"reference-count":13,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T00:00:00Z","timestamp":1764547200000},"content-version":"vor","delay-in-days":325,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,1,10]],"date-time":"2025-01-10T00:00:00Z","timestamp":1736467200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc."},{"DOI":"10.13039\/100004319","name":"Pfizer Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,3,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>In VERTIS CV, ertugliflozin was associated with a 30% risk reduction for adjudication-confirmed, first and total hospitalizations for heart failure (HHF) in participants with type 2 diabetes and atherosclerotic cardiovascular disease. We evaluated the impact of ertugliflozin on the broader spectrum of all reported heart failure (HF) events independent of adjudication confirmation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and results<\/jats:title>\n                    <jats:p>Data from participants who received ertugliflozin (5 or 15\u2009mg) were pooled and compared versus placebo. HF events included all investigator-reported HF adverse events (AEs) and serious AEs (SAEs) based on the narrow standardized Medical Dictionary for Regulatory Activities (MedDRA) query \u2018cardiac failure\u2019. Terms for orthopnoea, dyspnoea, and peripheral oedema were evaluated separately. The effect of ertugliflozin on the first HF event was assessed by Cox proportional hazard models. Total HF events were assessed by Andersen\u2013Gill models to account for first and recurrent events. A total of 8238 participants received \u22651 dose of ertugliflozin or placebo (mean follow-up 3.5\u2009years). Investigator-reported HF events and AE capture yielded 420 first and 627 total HF events (vs. 238 and 345 adjudication-confirmed HHF events, respectively, in the primary analyses). Ertugliflozin reduced the risk for first (hazard ratio [HR] 0.69; 95% confidence interval [CI] 0.57\u20130.84; p\u2009&amp;lt;\u20090.001) and total HF AEs (HR 0.66; 95% CI 0.57\u20130.78; p\u2009&amp;lt;\u20090.001), with similar results for first and total HF SAEs. Additionally, ertugliflozin reduced oedema risk, but not orthopnoea\/dyspnoea.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The effect of ertugliflozin was consistent across the spectrum of total investigator-reported HF AEs and was similar in magnitude to adjudicated HHF events.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ejhf.3511","type":"journal-article","created":{"date-parts":[[2025,1,10]],"date-time":"2025-01-10T11:03:18Z","timestamp":1736506998000},"page":"521-526","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Heart Failure Outcomes Captured by Adverse Event Reporting in Participants with Type 2 Diabetes and Atherosclerotic Cardiovascular Disease: Observations from the VERTIS CV Trial"],"prefix":"10.1093","volume":"27","author":[{"given":"Ambarish","family":"Pandey","sequence":"first","affiliation":[{"name":"Division of Cardiology, Department of Internal Medicine, UT Southwestern Medical Center , Dallas, TX ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ahmed A.","family":"Kolkailah","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Internal Medicine, UT Southwestern Medical Center , Dallas, TX ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Darren K.","family":"McGuire","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Internal Medicine, UT Southwestern Medical Center , Dallas, TX ,","place":["USA"]},{"name":"Parkland Health System , Dallas, TX ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert C.","family":"Frederich","sequence":"additional","affiliation":[{"name":"Pfizer Inc. , Groton, CT ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nilo B.","family":"Cater","sequence":"additional","affiliation":[{"name":"Pfizer Inc , New York, NY ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesco","family":"Cosentino","sequence":"additional","affiliation":[{"name":"Unit of Cardiology, Karolinska University Hospital Solna , Stockholm ,","place":["Sweden"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard E.","family":"Pratley","sequence":"additional","affiliation":[{"name":"AdventHealth Translational Research Institute , Orlando, FL ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samuel","family":"Dagogo-Jack","sequence":"additional","affiliation":[{"name":"University of Tennessee Health Science Center , Memphis, TN ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David Z.I.","family":"Cherney","sequence":"additional","affiliation":[{"name":"University of Toronto , Toronto, ON ,","place":["Canada"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Willy","family":"Wynant","sequence":"additional","affiliation":[{"name":"Biostatistics, Syneos Health , Morrisville, NC ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ira","family":"Gantz","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. , Rahway, NJ ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James P.","family":"Mancuso","sequence":"additional","affiliation":[{"name":"Pfizer Inc. , Groton, CT ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Urszula","family":"Masiukiewicz","sequence":"additional","affiliation":[{"name":"Pfizer Inc. , Groton, CT ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher P.","family":"Cannon","sequence":"additional","affiliation":[{"name":"Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School , Boston, MA ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2025,1,10]]},"reference":[{"key":"2026010913024262000_ejhf3511-bib-0001","doi-asserted-by":"crossref","first-page":"2117","DOI":"10.1056\/NEJMoa1504720","article-title":"Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes","volume":"373","author":"Zinman","year":"2015","journal-title":"N Engl J Med"},{"key":"2026010913024262000_ejhf3511-bib-0002","doi-asserted-by":"crossref","first-page":"644","DOI":"10.1056\/NEJMoa1611925","article-title":"Canagliflozin and cardiovascular and renal events in type 2 diabetes","volume":"377","author":"Neal","year":"2017","journal-title":"N Engl J 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