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Title: Omega-3 Lipid Emulsions Effective for Treatment of Parenteral Nutrition-Associated Liver Disease: Presented at PAS

"Omega-3 Lipid Emulsions Effective for Treatment of Parenteral Nutrition-Associated Liver Disease: Presented at PAS"

By Louise Gagnon TORONTO, CANADA -- May 7, 2007 -- Intravenous fish-oil based omega-3 lipids are both safe and effective for treatment of children with parenteral nutrition associated liver disease (PNALD), according to a small study presented here at the annual meeting of the Pediatric Academic Societies (PAS). Principal investigator Mark Puder, MD, PhD, assistant professor of surgery, Harvard Medical School, pediatric surgeon, Children's Hospital Boston, Boston, Massachusetts, United States, presented the results here at a poster session on May 5[^th.

The cause of PNALD is not known, but the composition of the intravenous fat emulsion (IFE) administered with IV nutrition may be thought to play a contributing role, Dr. Puder said.

The primary diagnoses of the children included necrotising entereocolitis, gastroschisis, intestinal atresia, and perforated small bowel obstruction.

Mortality rates in these infants can be as high as 70% if the condition worsens progressively, noted Dr. Puder

"It's a problem that needs to be addressed," said Dr. Puder, noting that omega-6 lipid emulsions are provided parenterally as standard nutritional support to pediatric patients with PNALD. "Once they develop cholestasis, they can't take parenteral feeds and the threat of mortality is high."

The investigators administered the omega-3 lipids emulsions to 18 infants, ranging in age from one to seven months, following a compassionate use protocol between September 2004 and August 2006.

Infants included in the study received fish-oil based IFE initially dosed at 0.2 to 0.5 g/kg/day, titrating to 1g/kg/day instead of their soy-based omega-6 emulsions. Infants who were eligible for the compassionate release of the substance included those who had a pre-parenteral nutrition dependence and cholestasis confirmed by liver biopsy or direct bilirubin greater than 2 mg/dL. Infants were excluded if there were other causes of chronic liver disease such as hepatitis C, cystic fibrosis, and biliary atresia.

After 91.5 days of therapy, all subjects had normalization of bilirubin (direct bilirubin < 2 mg/dL). Infants received varying degrees of enteral nutrition. Investigators observed no evidence of bleeding or essential fatty acid deficiency, and no complications related to infusion of omega-3 lipid emulsions.

Dr. Puder noted that 45 children have now been treated with omega-3 lipid emulsions under the hospital's compassionate use protocol.

The study was conducted independently.

The PAS meeting is sponsored by the American Pediatric Society, Society for Pediatric Research, and Ambulatory Pediatric Association.

American Academy of Pediatrics

[Presentation title: Parenteral Nutrition-Associated Liver Disease and Omega-3 Lipid Emulsions: Preliminary Findings on Safety and Efficacy. Abstract 5912.4, Poster Board 555

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