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Claims for Patent: 8,617,594

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Claims for Patent: 8,617,594

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:13/777,412
Patent Claims: 1. A method of reducing triglycerides comprising, identifying a group of subjects having a median triglyceride level of at least 500 mg/dl and orally administering daily to at least one subject in the group of subjects about 2500 mg to about 5000 mg of ethyl eicosapentaenoate, present in one or more capsules, wherein upon 12 weeks of said administering the at least one subject exhibits a reduction in triglycerides of at least about 15% without an increase of LDL-C of more than 5%.

2. The method of claim 1, wherein the group of subjects has a median fasting baseline LDL-C from about 50 mg/dl to about 300 mg/dl.

3. The method of claim 1, wherein the group of subjects has one or more of: a median baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a median baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a median baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a median baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.

4. The method of claim 1, wherein 12 weeks of said administering is effective to reduce triglycerides by at least about 30% without increasing LDL-C in the at least one subject.

5. The method of claim 1, wherein 12 weeks of said administering is effective to reduce apolipoprotein B in the at least one subject.

6. The method of claim 1, wherein 12 weeks of said administering is effective to reduce VLDL-C in the at least one subject.

7. The method of claim 1, wherein the group of subjects has a median fasting baseline triglyceride level of 500 mg/dl to 1500 mg/dl.

8. The method of claim 1, wherein the ethyl eicosapentaenoate is present in one or more dosage units.

9. The method of claim 8, wherein the dosage units are capsules.

10. A method of reducing triglycerides comprising, identifying a group of subjects having a median triglyceride level of at least 500 mg/dl and orally administering daily to at least one subject in the group 4 capsules, each capsule comprising about 900 mg to about 1 g of ethyl eicosapentaenoate, wherein upon 12 weeks of said administering the at least one subject exhibits a reduction in triglycerides by at least 15% without an increase of LDL-C of more than 5%.

11. The method of claim 10, wherein the group of subjects has a median fasting baseline LDL-C from about 50 mg/dl to about 300 mg/dl.

12. The method of claim 10, wherein the group of subjects has one or more of: a median baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a median baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a median baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a median baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.

13. The method of claim 10, wherein 12 weeks of said administering is effective to reduce triglycerides by at least about 30% without increasing LDL-C in the at least one subject.

14. The method of claim 10, wherein 12 weeks of said administering is effective to reduce apolipoprotein B in the at least one subject.

15. The method of claim 10, wherein 12 weeks of said administering is effective to reduce VLDL-C in the at least one subject.

16. The method of claim 10, wherein the group of subjects has a median fasting baseline triglyceride level of 500 mg/dl to 1500 mg/dl.

17. A method of reducing triglycerides comprising, identifying a group of subjects having a median triglyceride level of at least 500 mg/dl, orally administering daily to at least one subject in the group about 4 g of fatty acids, at least about 90% by weight of which are ethyl eicosapentaenoate, wherein upon 12 weeks of said administering the at least one subject exhibits a reduction in triglycerides by at least 15% without an increase of LDL-C of more than 5%.

18. The method of claim 17, wherein the group of subjects has a median fasting baseline LDL-C from about 50 mg/dl to about 300 mg/dl.

19. The method of claim 17, wherein the group of subjects has one or more of: a median baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a median baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a median baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a median baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.

20. The method of claim 17, wherein 12 weeks of said administering is effective to reduce triglycerides by at least about 30% without increasing LDL-C in the at least one subject.

21. The method of claim 17, wherein 12 weeks of said administering is effective to reduce apolipoprotein B in the at least one subject.

22. The method of claim 17, wherein 12 weeks of said administering is effective to reduce VLDL-C in the at least one subject.

23. The method of claim 17, wherein the group of subjects has a median fasting baseline triglyceride level of 500 mg/dl to 1500 mg/dl.

24. The method of claim 17, wherein the fatty acids other than ethyl eicosapentaenoate comprise at least one fatty acid selected from the group consisting of linolenic acid, ethyl linolenic acid, arachidonic acid, ethyl arachidonic acid, stearadonic acid, ethyl stearadonic acid, eicosatrienoic acid, ethyl eicosatrienoic acid, docosapentaenoic acid, and ethyl docosapentaenoic acid.

25. The method of claim 17, wherein the fatty acids are present in one or more dosage units.

26. The method of claim 25, wherein the dosage units are capsules.
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