Methods of treating hypertriglyceridemia

• US 8,431,560 B1
• Filed: 12/11/2012
• Issued: 04/30/2013
• 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
• Primary Examiner(s): Sznaidman, Marcos
• Application Number:
  US13/711,329
• Publication Number:
  US 20130096197A1
• Time in Patent Office: 140 Days
• Field of Search: 514/183, 514/549, 424/451
• US Class Current: 514/183
• 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 in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl comprising, administering orally to the subject 4 capsules per day, each capsule comprising about 900 mg to about 1 g of ethyl eicosapentaenoate and not more than about 3% docosahexaenoic acid or its esters, by weight of total fatty acids present, for a period of 12 weeks to effect a reduction in triglycerides in the subject.

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

3. The method of claim 1, wherein the subject has one or more of:

a baseline fasting non-HDL-C of about 200 mg/dl to about 400 mg/dl, a baseline fasting total cholesterol of about 250 mg/dl to about 400 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a baseline fasting HDL-C of about 10 mg/dl to about 60 mg/dl.

4. The method of claim 1, wherein said administering effects a reduction in fasting triglycerides of at least about 10% without increasing LDL-C by more than 5% in the subject.

5. The method of claim 1, wherein said administering effects a reduction in apolipoprotein B in the subject.

6. The method of claim 1, wherein said administering effects a reduction in VLDL-C in the subject.

7. The method of claim 1, wherein said administration effects reduction in fasting triglycerides of at least about 20% without increasing LDL-C in the subject.

8. The method of claim 1, wherein each capsule comprises about 950 mg of ethyl eicosapentaenoate.

9. The method of claim 1, wherein each capsule comprises about 975 mg of ethyl eicosapentaenoate.

10. The method of claim 1, wherein each capsule comprises about 1 g of ethyl eicosapentaenoate.

11. A method of reducing triglycerides in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl comprising, administering orally to the subject 4 capsules per day, each capsule comprising about 900 mg to about 1 g of ethyl eicosapentaenoate and not more than about 3% docosahexaenoic acid or its esters, by weight of total fatty acids present, for a period of 12 weeks to effect a reduction in triglycerides in the subject compared to placebo control.

12. The method of claim 11 wherein the subject has a fasting baseline LDL-C from about 50 mg/dl to about 300 mg/dl.

13. The method of claim 11, wherein the subject has one or more of:

a baseline fasting non-HDL-C of about 200 mg/dl to about 400 mg/dl, a baseline fasting total cholesterol of about 250 mg/dl to about 400 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a baseline fasting HDL-C of about 10 mg/dl to about 60 mg/dl.

14. The method of claim 11, wherein said administering effects a reduction in fasting triglycerides of at least about 10% without increasing LDL-C by more than 5% in the subject compared to placebo control.

15. The method of claim 11, wherein said administering effects a reduction in apolipoprotein B in the subject compared to placebo control.

16. The method of claim 11, wherein said administering effects a reduction in VLDL-C in the subject compared to placebo control.

17. The method of claim 11, wherein said administering effects reduction in fasting triglycerides of at least about 20% without increasing LDL-C in the subject compared to placebo control.

18. The method of claim 11, wherein each capsule comprises about 950 mg of ethyl eicosapentaenoate.

19. The method of claim 11, wherein each capsule comprises about 975 mg of ethyl eicosapentaenoate.

20. The method of claim 11, wherein each capsule comprises about 1 g of ethyl eicosapentaenoate.