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ToolsCALIBRE trial collaborative group (2025) Clinical Trial: A Multicentre Randomised Controlled Trial of Carvedilol Versus Variceal Band Ligation in Primary Prevention of Variceal Bleeding in Liver Cirrhosis (CALIBRE Trial). Alimentary Pharmacology and Therapeutics, 61 (11). pp. 1740-1754. ISSN 0269-2813
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Abstract
Background: The superior efficacy of non-selective beta-blockers (NSBB) compared with variceal band ligation (VBL) in the primary prevention of variceal bleeding is uncertain. Aim: To compare carvedilol versus VBL for primary prevention of variceal bleeding. Methods: CALIBRE was an investigator-initiated, multicentre, randomised, controlled, open-label trial. Participants were randomly assigned to 12.5 mg 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-effectiveness and adverse events. Recruitment closed early, mainly due to the impact of the pandemic. Results: 265 participants (10% of the intended sample size) from 52 sites were randomised to carvedilol (n = 133) or VBL (n = 132) 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]; 0.17–1.41); risk difference − 0.038 (95% CI; −0.094—0.017)). Serious adverse events occurred in one participant in each treatment arm, with no treatment-related deaths. Of the secondary outcomes, there were no statistically significant differences. Carvedilol was cheaper and resulted in slightly more quality-adjusted life years than VBL. Conclusions: The early terminated and, thus, underpowered CALIBRE trial showed no difference between carvedilol and VBL in the primary prevention of variceal bleeding in patients with cirrhosis and medium-to large-sized oesophageal varices. No untoward safety concerns were noted. Trial Registration: ISRCTN73887615.
| Item Type: | Article |
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| Additional Information: | All data requests should be submitted to the corresponding author. Access to anonymised data may be granted following review. A Data Sharing agreement may be required before data can be released. We are most grateful to the participants who have consented to participate in CALIBRE. We thank the British Society of Gastroenterology (BSG) and the British Association for the Study of the Liver (BASL) for their support of CALIBRE and for reviewing the protocol. We greatly appreciate the support of the Clinical Research Network (CRN) National Specialty Leads for hepatology, Professor William Rosenberg and Dr. Lynsey Corless, and the CRN network for supporting CALIBRE. |
| Uncontrolled Keywords: | gastrointestinal bleeding,liver cirrhosis,oesophageal varices,portal hypertension,hepatology,gastroenterology,pharmacology (medical) ,/dk/atira/pure/subjectarea/asjc/2700/2721 |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School Faculty of Medicine and Health Sciences > School of Health Sciences |
| UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Groups > Gastroenterology and Gut Biology Faculty of Medicine and Health Sciences > Research Centres > Metabolic Health |
| Related URLs: | |
| Depositing User: | LivePure Connector |
| Date Deposited: | 02 Jul 2026 09:29 |
| Last Modified: | 02 Jul 2026 09:29 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/103598 |
| DOI: | 10.1111/apt.70080 |
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