{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T11:00:47Z","timestamp":1792839647744,"version":"4.5.0"},"reference-count":25,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2025,4,16]],"date-time":"2025-04-16T00:00:00Z","timestamp":1744761600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health and Care Research","doi-asserted-by":"publisher","award":["16\/99\/02"],"award-info":[{"award-number":["16\/99\/02"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The superior efficacy of non\u2010selective beta\u2010blockers (NSBB) compared with variceal band ligation (VBL) in the primary prevention of variceal bleeding is uncertain.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To compare carvedilol versus VBL for primary prevention of variceal bleeding.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>CALIBRE was an investigator\u2010initiated, multicentre, randomised, controlled, open\u2010label trial. Participants were randomly assigned to 12.5\u2009mg carvedilol once daily or VBL. Inclusion criteria were cirrhosis and medium to large oesophageal varices that had not bled. The primary outcome is any variceal bleeding within 1 year of randomisation. Secondary outcomes include survival, other complications of cirrhosis, quality of life, cost\u2010effectiveness and adverse events. Recruitment closed early, mainly due to the impact of the pandemic.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>265 participants (10% of the intended sample size) from 52 sites were randomised to carvedilol (<jats:italic>n<\/jats:italic>\u2009=\u2009133) or VBL (<jats:italic>n<\/jats:italic>\u2009=\u2009132) between 22 January 2019 and 31 August 2022. 5\/133 participants (3.8%) in the carvedilol arm vs. 10\/132 participants (7.6%) in the VBL arm experienced variceal bleeding (risk ratio 0.50 (95% confidence interval [CI]; 0.17\u20131.41); risk difference\u2009\u2212\u20090.038 (95% CI; \u22120.094\u20140.017)). Serious adverse events occurred in one participant in each treatment arm, with no treatment\u2010related deaths. Of the secondary outcomes, there were no statistically significant differences. Carvedilol was cheaper and resulted in slightly more quality\u2010adjusted life years than VBL.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The early terminated and, thus, underpowered CALIBRE trial showed no difference between <jats:bold>c<\/jats:bold>arvedilol and VBL in the primary prevention of variceal bleeding in patients with cirrhosis and medium\u2010to large\u2010sized oesophageal varices. No untoward safety concerns were noted.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p>ISRCTN73887615<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.70080","type":"journal-article","created":{"date-parts":[[2025,4,17]],"date-time":"2025-04-17T02:20:31Z","timestamp":1744856431000},"page":"1740-1754","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Clinical Trial: A Multicentre Randomised Controlled Trial of Carvedilol Versus Variceal Band Ligation in Primary Prevention of Variceal Bleeding in Liver Cirrhosis (<scp>CALIBRE<\/scp> Trial)"],"prefix":"10.1111","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9043-6382","authenticated-orcid":false,"given":"Dhiraj","family":"Tripathi","sequence":"first","affiliation":[{"name":"Liver Unit University Hospitals Birmingham NHS Foundation Trust, Birmingham Health Partners  Birmingham UK"},{"name":"Immunology and Immunotherapy, College of Medicine and Health University of Birmingham, Birmingham Health Partners  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelly","family":"Handley","sequence":"additional","affiliation":[{"name":"Birmingham Clinical Trials Unit University of Birmingham  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Holden","sequence":"additional","affiliation":[{"name":"Birmingham Clinical Trials Unit University of Birmingham  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zainab","family":"Abdali","sequence":"additional","affiliation":[{"name":"Health Economics Unit, Department of Applied Health Sciences University of Birmingham  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sue","family":"Jowett","sequence":"additional","affiliation":[{"name":"Health Economics Unit, Department of Applied Health Sciences University of Birmingham  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Mathers","sequence":"additional","affiliation":[{"name":"Applied Health Sciences School of Health Sciences College of Medicine and Health University of Birmingham  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6271-2626","authenticated-orcid":false,"given":"Christopher","family":"Poyner","sequence":"additional","affiliation":[{"name":"School of Social Policy and Society University of Birmingham  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Richardson","sequence":"additional","affiliation":[{"name":"The Royal Liverpool Hospital NHS Foundation Trust  Liverpool UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2529-0409","authenticated-orcid":false,"given":"James","family":"Ferguson","sequence":"additional","affiliation":[{"name":"Liver Unit University Hospitals Birmingham NHS Foundation Trust, Birmingham Health Partners  Birmingham UK"},{"name":"Immunology and Immunotherapy, College of Medicine and Health University of Birmingham, Birmingham Health Partners  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1288-0749","authenticated-orcid":false,"given":"Ian","family":"Rowe","sequence":"additional","affiliation":[{"name":"Leeds institute for Medical Research, University of Leeds  Leeds UK"},{"name":"Leeds Liver Unit Leeds Teaching Hospitals NHS Trust  Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"CALIBRE trial collaborative group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,4,16]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl\u20102015\u2010309262"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.dld.2013.12.010"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen\u20102015\u2010010902"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2012-304038"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/MEG.0b013e3283367a99"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.23045"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2013.11.019"},{"key":"e_1_2_12_9_1","article-title":"Banding Ligation Versus Beta\u2010Blockers for Primary Prevention in Oesophageal Varices in Adults","volume":"8","author":"Gluud L. 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