Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial.

TLDR: Long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis in this trial.

About: This article is published in The Lancet.The article was published on 2018-06-16 and is currently open access. It has received 290 citations till now. The article focuses on the topics: Survival rate & Hepatorenal syndrome.

Figures

Figure 3: Overall survival Kaplan-Meier estimates for the probability of overall survival in the modified intention-to-treat population of SMT and SMT plus HA groups. The p value was calculated by the log-rank test. HA=human albumin. SMT=standard medical treatment.

Figure 2: Serum albumin concentration throughout the study period Serum albumin concentration in patients receiving SMT or SMT plus HA. Dots are mean values and bars are SD. HA=human albumin. SMT=standard medical treatment.

Figure 4: Competing risks analyses for 18-month all-cause mortality (A) Cumulative incidence of death and TIPS placement or liver transplantation in SMT and SMT plus HA groups. (B) CHR with bars indicating 95% CI and SHR with 95% CI, according to the competing risk multivariable model in which TIPS placement or liver transplantation are competing events. Age (5-year increase), viral cause of cirrhosis (yes or no), Child-Pugh score (1-point increase), and MELD-Na score (1-point increase) were independent predictors of all-cause mortality, whereas SMT plus HA (yes or no) was the sole variable associated with survival. TIPS=transjugular intrahepatic portosystemic shunt. SMT=standard medical treatment. HA=human albumin. CHR=cause-specific hazard ratio. SHR=subdistribution hazard ratio. MELD-Na=Model for End-Stage Liver Disease score incorporating serum sodium concentration.

Table 3: Summary of grade 3–4 non-liver-related adverse events according to the Common Terminology Criteria for Adverse Events version 4.0 classification

Figure 1: Trial profile For the SMT group, wrong inclusions were one advanced hepatocellular carcinoma, one neoplastic ascites, and two refractory ascites. For the SMT plus HA group, wrong inclusions were one advanced hepatocellular carcinoma and one refractory ascites. HA=human albumin. SMT=standard medical treatment.

Figure 5: Competing risks analysis for 18-month liver-related and non-liver-related mortality (A) Cumulative incidence of liver-related deaths, non-liver-related deaths, and TIPS placement or liver transplantation in SMT and SMT plus HA groups. (B) CHR with bars indicating 95% CI and SHR with 95% CI, according to the competing risk multivariable model in which liver-related deaths, non-liver-related deaths, and TIPS placement or liver transplantation are competing events. Age (5-year increase), viral cause of cirrhosis (yes or no), Child-Pugh score (1-point increase), and MELD-Na score (1-point increase) were independent predictors of liver-related mortality, whereas SMT plus HA (yes or no) was the sole variable associated with survival. Instead, age was the sole independent predictor of non-liver-related mortality. TIPS=transjugular intrahepatic portosystemic shunt. SMT=standard medical treatment. HA=human albumin. CHR=cause-specific hazard ratio. SHR=subdistribution hazard ratio. MELD-Na=Model for End-Stage Liver Disease score incorporating serum sodium concentration.

Frequently asked questions

Q1. What is the main endpoint of the study?

In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis. 

Q2. What was the primary endpoint of the study?

The primary endpoint was 18-month mortality, evaluated as difference of events and analysis of survival time in patients included in the modified intention-to-treat and per-protocol populations.