Abstract
Introduction Primary prophylaxis of variceal haemorrhage with non-selective betablockers (NSBB) or variceal band ligation (VBL) is now standard of care. There has been debate with regards to the safety and efficacy of NSBB however it has more recently been hypothesised that NSBB may be associated with improved survival.1 2 The aim of this study was to assess mortality in a cohort of patients randomised to either NSBB or VBL. Methods We retrospectively analysed 146 patients recruited to a multi-centre RCT between 07/04/2000 and 24/06/2006 designed to assess the efficacy of VBL versus NSBB in preventing first variceal bleed.3 We used electronic records to undertake a long term follow-up (up to 20 years) of this patient group with the primary outcome of all-cause mortality andsecondary end-points of liver disease-related mortality and transplant-free survival in patients within each treatment arm. Results 146 patients were included in analysis with baseline characteristics well matched between the NSBB (n = 73) and VBL (n=73) group. Mean Child-Pugh score at inclusion was 8.01 in NSBB group and 8.31 in VBL group. 127 had died or undergone liver transplant (LT) in the follow up period. NSBB offers a significant survival advantage when all-cause mortality is assessed with median survival in NSBB group of 7.82 years (95% CI 5.54–10.16), whereas median survival in VBL group was 4.18 years (95% CI 2.91–5.46) [p = 0.027] as shown in figure 1. A significant survival benefit is maintained when transplant-free survival is assessed with median survival of 5.25 years (95% CI 2.54–7.96) in NSBB and 3.02 years (95% CI 2.48–3.56) in VBL group [p=0.049]. Significance does not extend to liver-related mortality with median survival 3.25 years (NSBB) and 2.33 years (VBL) [p = 0.238]. Conclusions These data suggests that NSBB offers a significant survival benefit for patients with liver cirrhosis and portal hypertension. The difference in all-cause and liver-related mortality suggests that this survival benefit may not be entirely liver related. References Sinha R, Lockman KA, Mallawaarachchi N, Robertson M, Plevris JN, Hayes PC. Carvedilol use is associated with improved survival in patients with liver cirrhosis and ascites. J Hepatol 2017 Jul;67(1):40–46 Facciorusso, A., Roy, S., Livadas, S. et al. Nonselective Beta-Blockers Do Not Affect Survival in Cirrhotic Patients with Ascites. Dig Dis Sci 2018;63:1737–1746 Tripathi D, Ferguson JW, Kochar N, et al. Randomized controlled trial of carvedilol versus variceal band ligation for the prevention of first variceal bleed. Hepatology 2009 Sep;50(3):825–33
Highlights
The clinical course of cirrhosis does not follow a predictable trajectory
Transient elastography is strongly associated with outcomes in two large contemporary cohorts of patients with advanced chronic liver disease (ACLD)
Identification of ACLD using Transient elastography (TE) is a rational basis for a national cirrhosis registry to facilitate quality improvement and clinical trials in patients with liver disease
Summary
The clinical course of cirrhosis does not follow a predictable trajectory. Multistate models of disease progression have been adopted to assess its’ natural history, mainly in cohorts with biopsy proven cirrhosis. The aim of this study was to assess survival and competing risk of liver and non-liver related events in a cohort of patients with advanced chronic liver disease (ACLD) defined by TE using electronic health record (EHR) data. In clinical studies and in clinical practice, response to primary biliary cholangitis (PBC) treatment has been assessed using dichotomous biochemical response criteria Achieving these criteria may be associated with improved clinical outcomes, the benefit in patients (pts) with an incomplete response to treatment may be underestimated. This analysis assessed the extent and durability of obeticholic acid (OCA) response in pts with PBC not achieving the dichotomous primary endpoint in the phase 3 POISE study through 72 months of OCA treatment. O24 Figure 1 Change from baseline in ALP and total bilirubin through 72 months of OCA treatment A13
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