Methods of reducing RLP-C

• US 10,561,631 B2
• Filed: 06/11/2015
• Issued: 02/18/2020
• Est. Priority Date: 06/11/2014
• Status: Active Grant

• Current Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Original Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Inventors: Osterloh, Ian, Wicker, Pierre, Braeckman, Rene, Soni, Paresh, Manku, Mehar
• Primary Examiner(s): Rao, Savitha M
• Assistant Examiner(s): Polansky, Gregg
• Application Number:
  US14/737,115
• Publication Number:
  US 20150359775A1
• Time in Patent Office: 1,713 Days
• Field of Search: None
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/232 having three or more double bonds, e.g. etretinate

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 an RLP-C level of a subject on a statin therapy, having a baseline RLP-C level of at least 35 mg/dl, and having fasting baseline triglycerides of at least 500 mg/dl, the method comprising administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of ethyl eicosapentaenoate per day to effect the reduction of the subject'"'"'s RLP-C level compared to control subjects having fasting triglycerides of at least 500 mg/dl, wherein the control subjects received the statin therapy but not the pharmaceutical composition.

2. The method of claim 1, wherein the RLP-C level is reduced by at least about 15%.

3. The method of claim 1, wherein the RLP-C level is reduced by at least about 25%.

4. The method of claim 1, wherein about 2 g per day of ethyl eicosapentaenoate is administered to the subject.

5. The method of claim 1, wherein about 3.8 g to about 4 g per day of ethyl eicosapentaenoate is administered to the subject.

6. The method of claim 1, wherein the pharmaceutical composition is administered to the subject daily for a period of 1 to about 12 weeks.

7. The method of claim 1, wherein the pharmaceutical composition comprises at least about 95%, by weight of all fatty acids present, ethyl eicosapentaenoate.

8. The method of claim 1, wherein the pharmaceutical composition comprises no more than about 10%, by weight of all fatty acids present, docosahexaenoic acid or a derivative thereof, if any.

9. The method of claim 1, wherein the pharmaceutical composition comprises at least about 95%, by weight of all fatty acids present, ethyl eicosapentaenoate and no more than about 2%, by weight of all fatty acids present, docosahexaenoic acid or a derivative thereof, if any.

10. The method of claim 1, wherein the statin therapy is selected from the group consisting of 5 to 10 mg rosuvastatin, 10 to 20 mg atorvastatin, 20 to 40 mg simvastatin, and 10 to 20 mg simvastatin plus 5 to 10 mg ezetimibe.

11. The method of claim 1, wherein the statin therapy is selected from the group consisting of 20 to 40 mg rosuvastatin, 40 to 80 mg atorvastatin, 80 mg simvastatin, and 40 to 80 mg simvastatin plus 5 to 10 mg ezetimibe.

12. The method of claim 1, wherein administration of the pharmaceutical composition further effects a significant increase or a reduction in the subject'"'"'s HDL-apolipoprotein C-III (APOC3) level and/or a non-HDL-APOC3 level compared to baseline or placebo control.

13. The method of claim 1, wherein the baseline RLP-C level is about 35 mg/dl to about 90 mg/dl.