Claims for Patent: 8,440,650
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Summary for Patent: 8,440,650
| 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), Breackman; Rene (Richboro, PA), Soni; Paresh (Mystic, CT) |
| Assignee: | Amarin Pharmaceuticals Ireland Limited (Dublin, IE) |
| Application Number: | 13/711,324 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 8,440,650 |
| 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 g per day of a pharmaceutical composition comprising at least about 90% ethyl eicosapentaenoate, by weight of total fatty acids present, and not more than about 3% docosahexaenoic acid or its esters, by weight of total fatty acids
present, for a period of 12 weeks to effect a reduction in triglycerides in the subject.
2. The method of claim 1 wherein the subject has a fasting baseline LDL-C from about 50 mg/dl to about 300 mg/dl. 3. The method of claim 1, wherein the subject has one or more of: a baseline fasting non-HDL-C of about 200 mg/dl to about 400 mg/dl, a baseline fasting total cholesterol of about 250 mg/dl to about 400 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a baseline fasting HDL-C of about 10 mg/dl to about 60 mg/dl. 4. The method of claim 1, wherein said administering effects a reduction in fasting triglycerides of at least about 10% without increasing LDL-C by more than 5% in the subject. 5. The method of claim 1, wherein said administering effects a reduction in apolipoprotein B in the subject. 6. The method of claim 1, wherein said administering effects a reduction in VLDL-C in the subject. 7. The method of claim 1, wherein said administering effects reduction in fasting triglycerides of at least about 20% without increasing LDL-C in the subject. 8. 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 g per day of a pharmaceutical composition comprising at least about 90% ethyl eicosapentaenoate, by weight of total fatty acids present, and not more than about 3% docosahexaenoic acid or its esters, by weight of total fatty acids present, for a period of 12 weeks to effect a reduction in triglycerides in the subject compared to placebo control. 9. The method of claim 8 wherein the subject has a fasting baseline LDL-C from about 50 mg/dl to about 300 mg/dl. 10. The method of claim 8, wherein the subject has one or more of: a baseline fasting non-HDL-C of about 200 mg/dl to about 400 mg/dl, a baseline fasting total cholesterol of about 250 mg/dl to about 400 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a baseline fasting HDL-C of about 10 mg/dl to about 60 mg/dl. 11. The method of claim 8, wherein said administering effects a reduction in fasting triglycerides of at least about 10% without increasing LDL-C by more than 5% in the subject compared to placebo control. 12. The method of claim 8, wherein said administering effects a reduction in apolipoprotein B in the subject compared to placebo control. 13. The method of claim 8, wherein said administering effects a reduction in VLDL-C in the subject compared to placebo control. 14. The method of claim 8, wherein said administering effects a reduction in fasting triglycerides of at least about 20% without increasing LDL-C in the subject compared to placebo control. |
