METHODS OF TREATING HYPERTRIGLYCERIDEMIA

• US 20130171250A1
• Filed: 02/25/2013
• Published: 07/04/2013
• Est. Priority Date: 02/10/2009
• Status: Active Grant

• Current Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Original Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Inventors: Manku, Mehar, Osterloh, Ian, Wicker, Pierre, Braeckman, Rene, Soni, Paresh
• Granted Patent: US 8,546,372 B2
• Time in Patent Office: Days
• US Class Current: 424/451
• CPC Class Codes: A61K 31/202 having three or more double bonds, e.g. linolenic eicosanoids, e.g. leukotrienes A61K31/557
• CPC Class Codes: A61K 31/232 having three or more double bonds, e.g. etretinate
• CPC Class Codes: A61K 31/397 having four-membered rings, e.g. azetidine
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 7/00 Drugs for disorders of the blood or the extracellular fluid
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

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.

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 a pharmaceutical composition comprising about 4 g of ethyl eicosapentaenoate and not more than about 4% docosahexaenoic acid or its esters, by weight of all fatty acids, for a period of 12 weeks to reduce fasting triglycerides in the at least one subject.

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 composition 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 four capsules per day, each capsule comprising about 900 mg to about 1 g of ethyl eicosapentaenoate and not more than about 4% docosahexaenoic acid or its esters, by weight of all fatty acids, for a period of 12 weeks to reduce fasting triglycerides in the at least one subject.

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 and orally administering daily to at least one subject in the group a pharmaceutical composition comprising about 4 g of a pharmaceutical composition comprising at least about 90% ethyl eicosapentaenoate and not more than about 4% docosahexaenoic acid or its esters, by weight of all fatty acids, for a period of 12 weeks to reduce fasting triglycerides in the at least one subject.

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 composition is present in one or more dosage units.

25. The method of claim 24, wherein the dosage units are capsules.