Abstract

The PREDESCI trial,1 published in The Lancet , is the first randomised controlled trial (RCT) to evaluate the efficacy of non-selective beta-blockers in the primary prevention of hepatic decompensation in patients with compensated cirrhosis and clinically significant portal hypertension (CSPH). Two hundred and one patients with compensated cirrhosis and CSPH (baseline hepatic venous pressure gradient (HVPG) ≥10 mm Hg), no previous decompensation and no high-risk oesophageal varices were recruited. Acute HVPG responders to intravenous propranolol were randomised to propranolol or placebo and non-responders to carvedilol or placebo. The primary endpoint was decompensation (ascites, variceal bleeding or overt encephalopathy) or liver-related death. Decompensation or death occurred in 16% (16/100) in the beta-blocker group versus 27% (27/101) in the placebo group (HR 0.51, 95% CI 0.26 to 0.97, p=0.04). This difference was largely attributable to a significant reduction in the incidence of ascites (HR 0.42, 95% CI 0.19 to 0.92, p=0.03). There was a greater reduction in HVPG in the carvedilol group compared to propranolol (16% vs 10%, p=0.036) and no significant reduction in the placebo group. The development …

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