Claims for Patent: 9,566,260

Summary for Patent: 9,566,260

Title:	Treatment and prevention of liver disease associated with parenteral nutrition (PN)
Abstract:	The present invention is based on the discovery that parenteral nutrition (PN) induced liver disease, e.g. fatty liver disease, can be prevented and even reversed by administration of primarily omega-3-fatty acid with PN rather than the administration of the standard intravenous lipid emulsions that contain primarily plant derived omega-6 fatty acid. Thus, the present invention provides a method for treating or preventing liver disease in a human patient obtaining nutritional support through PN. The method comprises intravenous administration of an effective amount of an omega-3-fatty acid emulsion to the patient, wherein the patient is not administered phytosterols or plant derived fatty acids, e.g. omega-6 fatty acids derived from a plant source, and wherein the administration of the omega-3-fatty acid emulsion to the patient is for a period greater than three weeks. Preferably, the administration is for a period of greater than six weeks. More preferably, the administration is for a period greater than three months.
Inventor(s):	Puder; Mark (Medfield, MA), Gura; Kathleen M. (Norfolk, MA)
Assignee:	Children's Medical Center Corporation (Boston, MA)
Application Number:	11/267,663
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,566,260
Patent Claims:	1. A method for treating liver disease in a human patient in need thereof comprising intravenous administration of a lipid emulsion to the human patient, wherein the patient is obtaining nutritional requirements solely through total parenteral nutrition, and the lipid emulsion consists essentially of an effective amount of fish oil rich in omega-3-fatty acids and does not contain plant derived omega-6-fatty acids, wherein the patient is administered the lipid emulsion for a period greater than three weeks, wherein the patient is not administered any other form of lipid parenteral emulsion during the period of treatment, and wherein said human patient is a child under the age of 12. 2. A method of treatment of parenteral nutrition associated liver disease (PNALD) in a human infant having short-bowel syndrome, wherein the human infant is obtaining nutritional requirements solely through total parenteral nutrition, comprising administering to said infant having short-bowel syndrome an intravenous lipid emulsion consisting of fish oil-derived omega-3 fatty acids, wherein the infant having short-bowel syndrome is not administered phytosterols or plant derived fatty acids during said treatment of PNALD. 3. A method of treatment of parenteral nutrition associated liver disease (PNALD) in a human infant having short-bowel syndrome, wherein the human infant is obtaining nutritional requirements solely through total parenteral nutrition, the method comprising replacing a plant-derived lipid emulsion being intravenously administered to the human infant having short-bowel syndrome with an intravenous lipid emulsion consisting of fish oil-derived omega-3 fatty acids, wherein the infant having short-bowel syndrome is not administered phytosterols or plant-derived fatty acids during said treatment of PNALD. 4. The method of claim 1 or 2, wherein the administration of the omega-3-fatty acid lipid emulsion to the patient is for a period greater than 6 weeks. 5. The method of claim 1 or 2, wherein the administration of the omega-3-fatty acid lipid emulsion to the patient is for a period greater than 3 months. 6. The method of claim 1 or 2, wherein the liver disease is fatty liver disease. 7. The method of claim 1, 2 or 3, wherein the omega-3-fatty acid emulsion is prepared using an emulsifying agent selected from the group consisting of egg phosphatidylcholine, egg lecithin, L-.alpha.-dipalmitoyl phosphatidylcholine (DPPC), DL-.alpha.-dipalmitoyl phosphatidylethanolamine (DPPE), and dioleoyl phosphatidylcholine (DOPC). 8. The method of claim 1 or 2, wherein the omega-3-fatty acid lipid emulsion is administered until said patient is capable of receiving adequate nutrition from enteral food intake. 9. The method of claim 1 or 2, wherein the omega-3-fatty acid is administered at a dose of 0.2 g/kg/day to 3.0 g/kg/day. 10. The method of claim 1 or 2, wherein the omega-3-fatty acid is administered at a dose of 0.5 g/kg/day to 1.0 g/kg/day. 11. The method as in claim 1, wherein the child under the age of 12 is an infant.