Long-term albumin improves the outcomes of patients with decompensated cirrhosis and diabetes mellitus: Post hoc analysis of the ANSWER trial
Enrico Pompili and Maurizio Baldassarre—co-first authors.
Investigators of the Human Albumin for the Treatment of Ascites in Patients with Hepatic Cirrhosis (ANSWER) Trial are listed in the supplementary information.
Handling Editor: Alejandro Forner.
Abstract
Type-2 diabetes mellitus is a frequent comorbidity of cirrhosis independently associated with cirrhosis-related complications and mortality. This post hoc analysis of the ANSWER trial database assessed the effects of long-term human albumin (HA) administration on top of the standard medical treatment (SMT) on the clinical outcomes of a subgroup of 85 outpatients with liver cirrhosis, uncomplicated ascites and insulin-treated diabetes mellitus type 2 (ITDM). Compared to patients in the SMT arm, the SMT + HA group showed a better overall survival (86% vs. 57%, p = .016) and lower incidence rates of paracenteses, overt hepatic encephalopathy, bacterial infections, renal dysfunction and electrolyte disorders. Hospital admissions did not differ between the two arms, but the number of days spent in hospital was lower in the SMT + HA group. In conclusion, in a subgroup of ITDM outpatients with decompensated cirrhosis and ascites, long-term HA administration was associated with better survival and a lower incidence of cirrhosis-related complications.
CONFLICT OF INTEREST STATEMENT
MBa is part of the speakers' bureau for Octapharma AG, outside the submitted work. SP is consultant for PPTA, Resolution Therapeutics and Boehringer Ingelheim, and part of the speakers' bureau for Grifols and Mallinckrodt outside the submitted work. CA is consultant for Alfasigma, outside the submitted work. PC is part of the speakers' bureau for Grifols SA, Kedrion Biopharma SpA and Sobi SA, and reports research grants from Grifols SA and Octapharma SA, outside the submitted work. MBe is part of the speakers' bureau for Grifols SA, Octapharma AG, Takeda, CSL Behring GmbH and PPTA, and is a consultant for CLS Behring GmbH, Grifols SA and Takeda, outside the submitted work. GZ is part of the speakers' bureau for Grifols SA and Octapharma AG, and scientific consultant for PPTA, outside the submitted work. EP, GI, SNa, SNe, FGF and FL declare no potential competing interests.
Open Research
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
