Parenteral fish oil improves outcomes in patients with parenteral nutrition-associated liver injury.
OBJECTIVE
The objective was to determine the safety and efficacy of a fish oil-based intravenous lipid emulsion (ILE) in the treatment of parenteral nutrition-associated liver disease (PNALD).


BACKGROUND
PNALD can be a lethal complication in children with short bowel syndrome (SBS). ILE based on soybean oil administered with parenteral nutrition (PN) may contribute to its etiology.


METHODS
We performed an open-labeled trial of a fish oil-based ILE in 42 infants with SBS who developed cholestasis (serum direct bilirubin >2 mg/dL) while receiving soybean oil-based ILE. Safety and efficacy outcomes were compared with those from a contemporary cohort of 49 infants with SBS and cholestasis whose PN course included soybean ILE only. The primary efficacy end-point was time to reversal of cholestasis (direct bilirubin <=2 mg/dL).


RESULTS
Three deaths and 1 liver transplantation occurred in the fish oil cohort, compared with 12 deaths and 6 transplants in the soybean oil cohort (P = 0.005). Among survivors not transplanted during PN, cholestasis reversed while receiving PN in 19 of 38 patients in the fish oil cohort versus 2 of 36 patients in the soybean oil cohort. Based on Cox models, subjects receiving fish oil-based ILE experienced reversal of cholestasis 6 times faster (95% CI: 2.0-37.3) than those receiving soybean oil-based ILE. The provision of fish oil-based ILE was not associated with hypertriglyceridemia, coagulopathy, or essential fatty acid deficiency. Moreover, hypertriglyceridemic events and abnormal international normalized ratio levels were more common among controls.


CONCLUSIONS
Fish oil-based ILE is safe, may be effective in treating PNALD, and may reduce mortality and organ transplantation rates in children with SBS.
Puder
Mark
M
Department of Surgery, Children's Hospital Boston and Harvard Medical School, Boston, MA, USA. mark.puder@childrens.harvard.edu
Valim
Clarissa
C
Meisel
Jonathan A
JA
Le
Hau D
HD
de Meijer
Vincent E
VE
Robinson
Elizabeth M
EM
Zhou
Jing
J
Duggan
Christopher
C
Gura
Kathleen M
KM
D002779:Cholestasis / Q000209:etiology / Q000628:therapy*; D003627:Data Interpretation, Statistical; D005217:Fat Emulsions, Intravenous / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005395:Fish Oils / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D008111:Liver Function Tests; D016031:Liver Transplantation / Q000706:statistics & numerical data; D008297:Male; D010288:Parenteral Nutrition / Q000009:adverse effects / Q000379:methods*; D011446:Prospective Studies; D012778:Short Bowel Syndrome / Q000150:complications* / Q000628:therapy*; D013024:Soybean Oil / Q000009:adverse effects*; D015996:Survival Rate; D016896:Treatment Outcome
D005217:Fat Emulsions, Intravenous; D005395:Fish Oils; D013024:Soybean Oil