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Claims for Patent: 8,617,593

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Claims for Patent: 8,617,593

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)
Application Number:13/768,869
Patent Claims: 1. A method of treating hypertriglyceridemia in a subject on statin therapy comprising, administering to the subject daily a pharmaceutical composition comprising about 2500 mg to about 5000 mg of ethyl eicosapentaenoate and not more than about 5% docosahexaenoic acid or its esters, by weight of all fatty acids.

2. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in LDL-C of at least 5% compared to placebo control.

3. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting triglycerides of at least 15% compared to baseline.

4. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting apolipoprotein B compared to baseline.

5. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting VLDL-C compared to baseline.

6. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting VLDL-C of at least 5% compared to baseline.

7. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in hs-CRP compared to baseline.

8. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in non-HDL-C compared to baseline.

9. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in total cholesterol compared to baseline.

10. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in non-HDL-C, triglycerides and VLDL-C compared to baseline.

11. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in oxidized LDL-C compared to baseline.

12. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in lipoprotein associated phospholipase A2 compared to baseline.

13. The method of claim 1 wherein the ethyl eicosapentaenoate is administered to the subject in dosage units each comprising about 500 mg to about 1.5 g of ethyl eicosapentaenoate.

14. The method of claim 13 wherein the dosage units are capsules.

15. The method of claim 1 wherein the ethyl eicosapentaenoate is administered to the subject in dosage units each comprising about 900 mg to about 1 g of ethyl eicosapentaenoate.

16. The method of claim 15 wherein the dosage units are capsules.

17. The method of claim 1 wherein the ethyl eicosapentaenoate is administered to the subject in dosage units each comprising about 1 g of ethyl eicosapentaenoate.

18. The method of claim 17 wherein the dosage units are capsules.

19. The method of claim 1 wherein the ethyl eicosapentaenoate comprises at least about 90%, by weight, of all fatty acids.

20. The method of claim 1 wherein the fatty acid composition is added to the statin administration after the statin administration has been deemed inadequate.
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