4.6 Article

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

Journal

JOURNAL OF PEDIATRICS
Volume 230, Issue -, Pages 46-+

Publisher

MOSBY-ELSEVIER
DOI: 10.1016/j.jpeds.2020.09.068

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Funding

  1. Northsea Therapeutics
  2. Otsuka Pharmaceutical Company
  3. Alcresta
  4. Fresenius Kabi
  5. Food and Drug Administration Orphan Drug Development Grant Program
  6. March of Dimes
  7. FDA Orphan Drug Development Grant Program
  8. National Institutes of Health (NIH)/National Center for Advancing Translational Sciences (NCATS) [KL2TR000122]

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Children with intestinal failure-associated liver disease who received fish oil lipid emulsion (FOLE) had higher direct bilirubin levels, a higher rate of cholestasis resolution, lower aspartate aminotransferase to platelet ratio index scores, and fewer liver transplants compared to those who received soybean oil intravenous lipid emulsion (SOLE).
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.

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