Fish Oil Emulsion Reduces Liver Injury and Liver Transplantation in Children with Intestinal Failure-Associated Liver Disease: A Multicenter Integrated Study

J Pediatr. 2021 Mar;230:46-54.e2. doi: 10.1016/j.jpeds.2020.09.068. Epub 2020 Oct 8.

Abstract

Objective: To compare the aspartate aminotransferase to platelet ratio index, liver transplantation, and mortality rates between children with intestinal failure-associated liver disease who received fish oil lipid emulsion (FOLE) or soybean oil intravenous lipid emulsion (SOLE).

Study design: In this multicenter integrated analysis, FOLE recipients (1 g/kg/d) (n = 189) were compared with historical controls administered SOLE (≤3 g/kg/d) (n = 73).

Results: Compared with SOLE, FOLE recipients had a higher direct bilirubin level at baseline (5.8 mg/dL vs 3.0 mg/dL; P < .0001). Among FOLE recipients, 65% experienced cholestasis resolution vs 16% of SOLE recipients (P < .0001). The aspartate aminotransferase to platelet ratio index scores improved in FOLE recipients (1.235 vs 0.810 and 0.758, P < .02) but worsened in SOLE recipients (0.540 vs 2.564 and 2.098; P ≤ .0003) when baseline scores were compared with cholestasis resolution and end of study, respectively. Liver transplantation was reduced in FOLE vs SOLE (4% vs 12%; P = .0245). The probability of liver transplantation in relation to baseline direct or conjugated bilirubin (DB) was lower in FOLE vs SOLE recipients (1% vs 9% at DB of 2 mg/dL; 8% vs 35% at DB of 12.87 mg/dL; P = .0022 for both). Death rates were similar (FOLE vs SOLE: 10% vs 14% at DB of 2 mg/dL; 17% vs 23% at a DB of 12.87 mg/dL; P = .36 for both).

Conclusions: FOLE recipients experienced a higher rate of cholestasis resolution, lower aspartate aminotransferase to platelet ratio index, and fewer liver transplants compared with SOLE. This study demonstrates that FOLE may be the preferred parenteral lipid emulsion in children with intestinal failure-associated liver disease when DB reaches 2 mg/dL.

Trial registration: Clinicaltrials.gov: NCT00910104 and NCT00738101.

Keywords: APRI score; Omegaven; intestinal failure associated liver disease; intravenous lipid emulsion; liver transplant; soybean oil.

Publication types

  • Multicenter Study

MeSH terms

  • Aspartate Aminotransferases / blood
  • Case-Control Studies
  • Cholestasis / etiology
  • Cholestasis / mortality
  • Cholestasis / therapy*
  • Fat Emulsions, Intravenous / administration & dosage*
  • Female
  • Fish Oils / administration & dosage*
  • Fish Oils / pharmacology
  • Humans
  • Infant
  • Infant, Newborn
  • Intestinal Diseases / complications
  • Liver Transplantation / statistics & numerical data
  • Male
  • Parenteral Nutrition, Total / adverse effects*
  • Soybean Oil / administration & dosage
  • Soybean Oil / adverse effects

Substances

  • Fat Emulsions, Intravenous
  • Fish Oils
  • Soybean Oil
  • Aspartate Aminotransferases

Associated data

  • ClinicalTrials.gov/NCT00910104
  • ClinicalTrials.gov/NCT00738101