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Claims for Patent: 8,293,727

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Claims for Patent: 8,293,727

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:12/702,889
Patent Claims: 1. A method of lowering apolipoprotein B in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl, who does not receive a concurrent lipid altering therapy, comprising administering orally to the subject about 4 g per day of a pharmaceutical composition comprising at least about 96% by weight, ethyl eicosapentaenoate (ethyl-EPA) and substantially no docosahexaenoic acid (DHA) or its esters for a period of at least 12 weeks to effect a reduction in apolipoprotein B of at least 5% without substantially increasing LDL-C compared to a second subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl, who does not receive a concurrent lipid altering therapy, and who has not received the pharmaceutical composition.

2. The method of claim 1 wherein the pharmaceutical composition is administered to the subject 1 to 4 times per day.

3. The method of claim 1 wherein the pharmaceutical composition is present in one or more capsules.

4. The method of claim 1 wherein the concurrent lipid-altering therapy comprises a statin.

5. The method of claim 1 wherein the subject and the second subject have one or more of: a baseline non-HDL-C of about 200 mg/dl to about 300 mg/dl; a baseline total cholesterol of about 250 mg/dl to about 300 mg/dl; a baseline vLDL-C of about 140 mg/dl to about 200 mg/dl; and/or a baseline HDL-C of about 10 to about 80 mg/dl.

6. The method of claim 1 comprising: administering to the subject about 4 g per day of the pharmaceutical composition for a period of 12 weeks to effect a reduction in: triglycerides compared to said second subject.

7. The method of claim 6 comprising administering to the subject about 4 g of the pharmaceutical composition daily for a period of 12 weeks to effect a reduction in: triglycerides of at least about 25% as compared to said second subject.

8. The method of claim 1 wherein the pharmaceutical composition is packaged together with instructions for using the composition to treat a cardiovascular disorder.

9. The method of claim 3, wherein the pharmaceutical composition is packaged in blister packages of about 1 to about 20 capsules per sheet.

10. The method of claim 1 comprising administering to the subject about 4 g of the pharmaceutical composition daily for a period of 12 weeks to effect a reduction in Lp-PLA2 of at least 5% compared to said second subject.

11. The method of claim 6 comprising administering to the subject about 4 g of the pharmaceutical composition daily for 12 weeks to effect a reduction in non-HDL-C levels of at least 5% compared to said second subject.

12. The method of claim 1 wherein the subject and the second subject have a fasting baseline triglyceride level of about 750 mg/dl to about 1500 mg/dl.

13. The method of claim 1 comprising administering to the subject about 4 g of the pharmaceutical composition daily for a period of 12 weeks to effect a reduction in total cholesterol of at least 5% compared to said second subject.

14. The method of claim 1 wherein the subject and the second subject consume a Western diet.

15. The method of claim 1 or 14, wherein no fatty acid of the pharmaceutical composition, except for ethyl-EPA, comprises more than about 0.6% by weight of all fatty acids combined.

16. A method of lowering apolipoprotein B in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl, who does not receive a concurrent lipid altering therapy, comprising administering orally to the subject about 4 g per day of a pharmaceutical composition comprising at least about 96% by weight, ethyl eicosapentaenoate and substantially no docosahexaenoic acid or its esters for a period of at least 12 weeks effective to reduce in a first patient population receiving 4 g per day of said composition, members of which first population have a baseline triglyceride level of about 500 mg/dl to about 1500 mg/dl and who do not receive a concurrent lipid altering therapy, a median apolipoprotein B level by at least 5%, compared to a median apolipoprotein B level, observed in a second patient population, members of which second population have a baseline triglyceride level of 500 mg/dl to about 1500 mg/dl, who do not receive a concurrent lipid altering therapy, and who have not received the pharmaceutical composition.

17. The method of claim 16 wherein the concurrent lipid altering therapy comprises statin therapy.
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