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Generated: August 21, 2017

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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 (Birmingham, 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:Apr 23, 2014
Application Number:14/259,724
Claims:1. A method of lowering non-HDL-C in a subject having triglycerides of 200 mg/dl or greater who is receiving statin therapy comprising, administering to the subject daily for a period effective to reduce non-HDL-C 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 docosahexaenoic acid in an amount up to about 20%, by weight of fatty acids present, and docosapentaenoic acid in an amount up to about 10% 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 non-HDL-C by at least about 3% in the subject.

3. 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.

4. The method of claim 2 wherein the reduction is relative to placebo control.

5. The method of claim 3 wherein the reduction is relative to placebo control.

6. The method of claim 2 wherein the reduction is relative to a baseline non-HDL-C level in the subject.

7. The method of claim 3 wherein the reduction is relative to a baseline non-HDL-C level in the subject.

8. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to decrease triglycerides in the subject.

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

10. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce total cholesterol in the subject.

11. The method of claim 1 wherein the eicosapentaenoic acid is present in an amount of about 1100 mg.

12. The method of claim 1 wherein the eicosapentaenoic acid is present in an amount of about 1650 mg.

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

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

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

16. The method of claim 1 wherein the composition is administered to the subject in one or more dosage units per day.
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