Clinical Trial: A Multicentre Randomised Controlled Trial of Carvedilol Versus Variceal Band Ligation in Primary Prevention of Variceal Bleeding in Liver Cirrhosis (CALIBRE Trial)
GastroenterologiaResumo original em inglês
O que aconteceu
The superior efficacy of non-selective beta-blockers (NSBB) compared with variceal band ligation (VBL) in the primary prevention of variceal bleeding is uncertain.
To compare carvedilol versus VBL for primary prevention of variceal bleeding.
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.
ISRCTN73887615.
O que encontraram
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.
Por que isso importa
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.
Resumo publicado sob licença CC BY. A tradução para o português ainda não chegou a este estudo.
O estudo original
Clinical Trial: A Multicentre Randomised Controlled Trial of Carvedilol Versus Variceal Band Ligation in Primary Prevention of Variceal Bleeding in Liver Cirrhosis (CALIBRE Trial)
Dhiraj Tripathi, Kelly Handley, Lisa Holden, Zainab Abdali, Sue Jowett, Jonathan Mathers, Christopher Poyner, Paul Richardson, James Ferguson, Ian Rowe et al.
Descritores MeSH
- Liver Cirrhosis
- Gastrointestinal Hemorrhage
- Esophageal and Gastric Varices
- Primary Prevention
- Adrenergic beta-Antagonists
- Carvedilol
- Male
- Middle Aged
- Quality of Life
- Treatment Outcome