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Claims for Patent: 8,318,715

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Claims for Patent: 8,318,715

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:13/282,145
Patent Claims: 1. A method of reducing triglycerides and 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 triglycerides and apolipoprotein B in the subject compared to a triglyceride level and apolipoprotein B level in 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 composition is administered to the subject 1 to 4 times per day.

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

4. The method of claim 1 comprising administering the composition to the subject daily for a period of 12 weeks to effect a reduction in apolipoprotein B and substantially no increase in LDL-C levels compared to the second subject.

5. The method of claim 1 comprising administering 4 g of the composition to the subject daily for a period of 12 weeks to effect at least a 5% reduction in triglyceride levels compared to a triglyceride level in the second subject.

6. The method of claim 1 comprising administering 4 g of the composition to the subject daily for a period of 12 weeks to effect at least a 5% reduction in VLDL-C levels compared to a VLDL-C level in the second subject.

7. The method of claim 1 comprising administering 4 g of the composition to the subject daily for a period of 12 weeks to effect a reduction in non-HDL-C levels compared to a non-HDL-C level in the second subject.

8. The method of claim 1 comprising administering 4 g of the composition to the subject daily for a period of 12 weeks to effect a reduction in triglycerides of at least about 25% and a reduction in non-HDL C of at least about 5% as compared to the second subject.

9. The method of claim 1 comprising administering 4 g of the composition to the subject daily for a period of 12 weeks to effect a reduction in Lp-PLA2 of at least about 15% as compared a Lp-PLA2 level in the second subject.

10. The method of claim 9 comprising administering 4 g of the composition to the subject daily for a period of 12 weeks to effect a reduction in total cholesterol of at least about 15% as compared a total cholesterol level in the second subject.

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

12. The method of claim 1 wherein the concomitant lipid-altering therapy is a statin.

13. A method of reducing triglycerides 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 statistically significant reduction in triglycerides without effecting a statistically significant increase in LDL-C or apolipoprotein B in the subject.

14. The method of claim 13 comprising administering to the subject about 4 g per day of the pharmaceutical composition to effect a statistically significant reduction in triglycerides and apolipoprotein B without effecting a statistically significant increase of in the subject.

15. The method of claim 13 wherein the subject and the second subject consume a Western diet.

16. The method of claim 13 wherein the concomitant lipid-altering therapy is a statin.

17. A method of reducing triglycerides and 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 reduction in triglycerides and apolipoprotein B in the subject compared to a triglyceride level and an apolipoprotein B level at a baseline prior to initial administration of the pharmaceutical composition.

18. The method of claim 17 wherein the subject and the second subject consume a Western diet.

19. The method of claim 17 wherein the concomitant lipid-altering therapy is a statin.
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