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Claims for Patent: 8,415,335

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Claims for Patent: 8,415,335

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 Pharmaceutical Ireland Limited (Dublin, IE)
Application Number:13/349,157
Patent Claims: 1. A method of reducing triglycerides in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 2000 mg/dl comprising, administering to the subject about 4 g per day of a pharmaceutical composition comprising at least about 96%, by weight, ethyl eicosapentaenoate for a period of 12 weeks, effective to reduce fasting triglycerides by at least about 15% compared to a fasting triglyceride level at a baseline prior to initial administration of the pharmaceutical composition.

2. The method of claim 1 wherein upon administering about 4 g of the composition to the subject daily for said period the subject further exhibits at least one additional lipid outcome selected from (a) a greater than 5% reduction in fasting apolipoprotein B and (b) substantially no increase or a reduction in fasting LDL-C compared to a second subject having a baseline triglyceride level of 500 mg/dl to about 2000 mg/dl who has not received the pharmaceutical composition.

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

4. The method of claim 1 wherein the composition is present in a capsule.

5. The method of claim 1 wherein the subject has a baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl; a baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl; a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl; and a baseline fasting HDL-C of about 10 to about 80 mg/dl.

6. The method of claim 5 wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for said period the subject exhibits (a) a greater than 5% reduction in fasting apolipoprotein B and (b) substantially no increase or a reduction in fasting LDL-C, compared to a control subject having a baseline triglyceride level of 500 mg/dl to about 2000 mg/dl who has not received the pharmaceutical composition.

7. The method of claim 6 wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for said period the subject further exhibits a reduction in fasting VLDL-C compared to a fasting VLDL-C level at a baseline prior to initial administration of the pharmaceutical composition.

8. The method of claim 7 wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for said period the subject exhibits a reduction in fasting non-HDL-C compared to a fasting non-HDL-C level at a baseline prior to initial administration of the pharmaceutical composition.

9. The method of claim 8 wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for said period the subject exhibits a reduction in fasting total cholesterol compared to a fasting total cholesterol level at a baseline prior to initial administration of the pharmaceutical composition.

10. The method of claim 7 wherein the reduction in fasting VLDL-C is at least a 15% reduction compared to said baseline.

11. The method of claim 8 wherein the reduction in fasting non-HDL-C is at least a 15% reduction compared to said baseline.

12. The method of claim 9 wherein the reduction in fasting total cholesterol is at least a 5% reduction compared to said baseline.

13. The method of claim 1 wherein said period effective to reduce fasting triglycerides by at least about 15% compared to a fasting triglyceride level at a baseline prior to initial administration of the pharmaceutical composition comprises 12 weeks.

14. A method of reducing triglycerides and apolipoprotein B in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 2000 mg/dl and who is not on concomitant statin therapy comprising, administering to the subject about 4 g per day of a pharmaceutical composition comprising at least about 96%, by weight, ethyl eicosapentaenoate for a period of 12 weeks, effective to reduce fasting triglycerides by at least 25% and to reduce fasting apolipoprotein B, compared to a second subject having a baseline triglyceride level of 500 mg/dl to about 2000 mg/dl who has not received the pharmaceutical composition and is not on concomitant statin therapy.

15. The method of claim 14 wherein the composition is administered to the subject 1 to 4 times per day.

16. The method of claim 15 wherein the composition is present in a capsule.

17. The method of claim 14 wherein the subject and the second subject have a baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl; a baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl; a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl; and a baseline fasting HDL-C of about 10 to about 80 mg/dl.

18. The method of claim 17 wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for a period of 12 weeks the subject exhibits a reduction in fasting LDL-C compared to a fasting LDL-C level at a baseline prior to initial administration of the pharmaceutical composition.

19. The method of claim 18 wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for a period of 12 weeks the subject exhibits a reduction in fasting VLDL-C of at least 15% compared to a fasting VLDL-C level at a baseline prior to initial administration of the pharmaceutical composition.

20. The method of claim 19 wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for a period of 12 weeks the subject exhibits a reduction in fasting non-HDL-C of at least 5% compared to a fasting non-HDL-C level at a baseline prior to initial administration of the pharmaceutical composition.

21. The method of claim 20 wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for a period of 12 weeks the subject exhibits a reduction in total cholesterol of at least 5% compared to a total cholesterol level at a baseline prior to initial administration of the pharmaceutical composition.

22. A method of reducing triglycerides and apolipoprotein B in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 2000 mg/dl and who is not on concomitant lipid altering therapy comprising, administering to the subject about 4 g per day of a pharmaceutical composition comprising at least about 96%, by weight, ethyl eicosapentaenoate for a period of 12 weeks, wherein upon administering the composition to the subject daily for said period of 12 weeks the subject exhibits a reduction in fasting triglycerides of at least about 25% and a reduction in fasting apolipoprotein B compared to a control subject having a baseline triglyceride level of 500 mg/dl to about 2000 mg/dl who has not received the pharmaceutical composition and is not on concomitant lipid altering therapy.

23. The method of claim 22 wherein the composition is administered to the subject 1 to 4 times per day.

24. The method of claim 23 wherein the composition is present in a capsule.

25. The method of claim 22 wherein the subject has a baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl; a baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl; a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl; and a baseline fasting HDL-C of about 10 to about 80 mg/dl.

26. The method of claim 25 wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for the period of 12 weeks the subject exhibits a reduction in fasting LDL-C compared to a fasting LDL-C level at a baseline prior to initial administration of the pharmaceutical composition.

27. The method of claim 26 wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for the period of 12 weeks the subject exhibits a reduction in fasting VLDL-C of at least 15% compared to a fasting VLDL-C level at a baseline prior to initial administration of the pharmaceutical composition.

28. The method of claim 27 wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for the period of 12 weeks the subject exhibits a reduction in fasting non-HDL-C of at least 5% compared to a fasting non-HDL-C level at a baseline prior to initial administration of the pharmaceutical composition.

29. The method of claim 28 wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for the period of 12 weeks the subject exhibits a reduction in fasting total cholesterol of at least 5% compared to a fasting total cholesterol level at a baseline prior to initial administration of the pharmaceutical composition.
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