Abstract
No therapies have been proven to increase survival after a hepatic encephalopathy (HE) episode. We hypothesize that two doses of albumin could improve 90-day survival rates after a HE episode. Methods: (1) A randomized double-blind, placebo-controlled trial (BETA) was conducted in 12 hospitals. The effect of albumin (1.5 g/kg at baseline and 1 g/kg on day 3) on 90-day survival rates after a HE episode grade II or higher was evaluated. (2) A meta-analysis of individual patient’s data for survival including two clinical trials (BETA and ALFAE) was performed. Results: In total, 82 patients were included. Albumin failed to increase the 90-day transplant-free survival (91.9% vs. 80.5%, p = 0.3). A competing risk analysis was performed, observing a 90-day cumulative incidence of death of 9% in the albumin group vs. 20% in the placebo (p = 0.1). The meta-analysis showed a benefit in the albumin group, with a lower rate of clinical events (death or liver transplant) than patients in the placebo (HR, 0.44; 95% CI, 0.21–0.82), when analyzed by a competing risk analysis (90-days mortality rate of 11% in the albumin group vs. 30% in the placebo, p = 0.02). Conclusions: Repeated doses of albumin might be beneficial for patient’s survival as an add-on therapy after an HE episode, but an adequately powered trial is needed.
Highlights
Hepatic encephalopathy (HE) is a life-threatening complication of cirrhosis
A tendency towards a better survival outcome was observed within the albumin group
The only difference between the ALFAE and the BETA studies was the lack of MELD restrictions in the ALFAE study, as well as the definition of ACLF that has changed over the years
Summary
Hepatic encephalopathy (HE) is a life-threatening complication of cirrhosis. HE has 90-day mortality rates of 20% in patients with grade II and 45% in patients with grade III or IV [1]. The results of the ALFAE study [11] were especially encouraging since the albumin group exhibited a decrease of 29% in mortality rate. None of these two studies were designed to address survival. Another recent study failed to demonstrate an effect of albumin to increase in-hospital survival, a lower frequency of infections and a higher survival rate were observed within the treatment group [12]; in a similar manner, another randomized trial failed to prevent decompensation (i.e., infections, kidney disfunction) or death among hospitalized cirrhotic patients [13]. We aimed at investigating whether albumin could increase 90-day survival rates after an acute HE episode
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