IP Library Granted Patent US 8,546,372
Granted Patent B2
US 8,546,372 · App. 13/776,261 · Granted Oct 1, 2013

Methods of treating hypertriglyceridemia

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Quick Facts
Patent No.
US 8,546,372
App. No.
13/776,261
Granted
Oct 1, 2013
Kind
B2
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 (25)

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, 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, 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, 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.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded Nov 19, 2020
From: CPPIB CREDIT EUROPE S.À R.L.
To: AMARIN PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 054484/0552 →
SECURITY INTEREST Recorded Dec 21, 2017
From: AMARIN PHARMACEUTICALS IRELAND LIMITED
To: CPPIB CREDIT EUROPE S.À R.L.
Reel/Frame 044938/0257 →
THIS SUBMISSION IS TO CORRECT THE ASSIGNEE'S NAME AND ADDRESS ON A COVER SHEET PREVIOUSLY RECORDED AT REEL/FRAME 030749/0557 Recorded Jun 16, 2014
From: MANKU, MEHAR; OSTERLOH, IAN; WICKER, PIERRE; BRAECKMAN, RENE; SONI, PARESH
To: AMARIN PHARMA, INC.
Reel/Frame 033182/0136 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 16, 2014
From: AMARIN PHARMA, INC.
To: AMARIN PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 033192/0572 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 8, 2013
From: MANKU, MEHAR; OSTERLOH, IAN; WICKER, PIERRE; BRAECKMAN, RENE; SONI, PARESH
To: AMARIN PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 030749/0557 →