Claims for Patent: 8,399,446

Summary for Patent: 8,399,446

Title:	Methods of treating hypertriglyceridemia
Abstract:	In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
Inventor(s):	Manku; Mehar (England, GB), Osterloh; Ian (Kent, GB), Wicker; Pierre (Mystic, CT), Braeckman; Rene (Richboro, PA), Soni; Paresh (Mystic, CT)
Assignee:	Amarin Pharmaceuticals Ireland Limited (Dublin, IE)
Application Number:	13/610,217
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,399,446
Patent Claims:	1. A method of reducing triglycerides in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl comprising: administering orally to the subject about 4 capsules per day, each capsule comprising about 900 mg to about 1 g of ethyl eicosapentaenoate and not more than about 3% docosahexaenoic acid or its esters, by weight of all fatty acids present, for a period of at least about 12 weeks to effect a reduction in triglycerides without substantially increasing LDL-C compared to placebo control. 2. The method of claim 1, wherein the subject has a fasting baseline LDL-C from about 40 mg/dl to about 115 mg/dl. 3. The method of claim 1, wherein subject has one or more of: a median baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a median baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a median baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a median baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl. 4. The method of claim 1, comprising administering to the subject said 4 capsules daily for the period of at least about 12 weeks to effect a reduction in fasting triglycerides of at least about 10% without substantially increasing LDL-C compared to placebo control. 5. The method of claim 1, comprising administering to the subject said 4 capsules daily for the period of at least about 12 weeks to effect a reduction in fasting triglycerides of at least about 25% without substantially increasing LDL-C compared to placebo control. 6. The method of claim 1, comprising administering to the subject said 4 capsules daily for the period of at least about 12 weeks to effect a reduction in apolipoprotein B compared to placebo control. 7. The method of claim 1, comprising administering to the subject said 4 capsules daily for the period of at least about 12 weeks to effect a reduction in VLDL-C compared to placebo control. 8. The method of claim 1 wherein each capsule comprises about 925 mg of ethyl eicosapentaenoate. 9. The method of claim 1 wherein each capsule comprises about 950 mg of ethyl eicosapentaenoate. 10. The method of claim 1 wherein each capsule comprises about 975 mg of ethyl eicosapentaenoate. 11. The method of claim 1 wherein each capsule comprises about 1 g of ethyl eicosapentaenoate.