ANSWER
Trial question
What is the effect of long-term human albumin administration in patients with decompensated cirrhosis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 431
431 patients (135 female, 296 male).
Inclusion criteria: patients with decompensated cirrhosis.
Key exclusion criteria: refractory ascites; recent complications of cirrhosis; TIPS; active HCC; liver transplantation; ongoing alcohol abuse; extrahepatic organ failure; albumin use for the treatment of ascites.
Interventions
N=218 human albumin plus standard medical treatment (40 g twice weekly for 2 weeks and then 40 g weekly plus standard care for up to 18 months).
N=213 standard medical treatment alone (standard care indicated according to the clinical practice guidelines).
Primary outcome
Death at 18 months
23%
34%
34.0 %
25.5 %
17.0 %
8.5 %
0.0 %
Human albumin plus standard medical
treatment
Standard medical treatment
alone
Significant
decrease ▼
NNT = 9
Significant decrease in death at 18 months (23% vs. 34%; HR 0.62, 95% CI 0.4 to 0.95).
Secondary outcomes
Significant decrease in cumulative incidence of refractory ascites (0.25 vs. 0.48; HR 0.43, 95% CI 0.29 to 0.62).
Significant decrease in incidence of first paracentesis (38% vs. 66%; HR 0.48, 95% CI 0.35 to 0.54).
Significant decrease in the rate of cumulative incidence of the endpoint need for ≥ 3 paracenteses per month (12% vs. 29%; HR 0.33, 95% CI 0.19 to 0.58).
Safety outcomes
No significant difference in grade 3-4 non-liver related adverse events.
Conclusion
In patients with decompensated cirrhosis, human albumin plus standard medical treatment was superior to standard medical treatment alone with respect to death at 18 months.
Reference
Paolo Caraceni, Oliviero Riggio, Paolo Angeli et al. Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial. Lancet. 2018 Jun 16;391(10138):2417-2429.
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