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Details for Patent: 8,613,945

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Details for Patent: 8,613,945

Title:Stable pharmaceutical composition and methods of using same
Abstract: The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.
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)
Filing Date:Nov 26, 2012
Application Number:13/685,291
Claims:1. A method of treating high triglycerides in a subject receiving statin therapy comprising, administering to the subject daily for a period effective to reduce triglycerides in the subject a pharmaceutical composition comprising: an amount of eicosapentaenoic acid selected from the group consisting of about 1100 mg, about 1650 mg and about 2200 mg; and not more than about 20% docosahexaenoic acid, by weight of fatty acids present.

2. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce triglycerides by at least 10% in the subject.

3. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce triglycerides by at least 15% in the subject.

4. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce non-HDL-C in the subject.

5. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce non-HDL-C by at least about 5% in the subject.

6. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to increase HDL-C in the subject.

7. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce lipoprotein associated phospholipase A2 in the subject.

8. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce lipoprotein associated phospholipase A2 by at least 5% in the subject.

9. The method of claim 1 wherein the effective amount of eicosapentaenoic acid is about 1100 mg.

10. The method of claim 9 wherein said administration results in an increase in plasma eicosapentaenoic acid levels of at least 200% in the subject.

11. The method of claim 1 wherein the effective amount of eicosapentaenoic acid is about 1650 mg.

12. The method of claim 11 wherein said administration results in an increase in plasma eicosapentaenoic acid levels of at least 200% in the subject.

13. The method of claim 1 wherein the effective amount of eicosapentaenoic acid is about 2200 mg.

14. The method of claim 13 wherein said administration results in an increase in plasma eicosapentaenoic acid levels of at least 400% in the subject.

15. The method of claim 1 wherein the pharmaceutical composition comprises about 20%, by weight of total fatty acids, docosahexaenoic acid.

16. The method of claim 1 wherein the period is at least about 12 weeks.
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