METHODS OF TREATING HYPERTRIGLYCERIDEMIA

• US 20130164375A1
• Filed: 02/25/2013
• Published: 06/27/2013
• 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 8,524,698 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, administering daily to a subject having a fasting baseline triglyceride level of at least 500 mg/dl 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, wherein the pharmaceutical composition, when administered for twelve weeks to a first patient population having said baseline triglyceride level is effective to reduce a median triglyceride level in the first patient population by at least about 25% compared to a median triglyceride level observed in a second patient population having said baseline triglyceride level who has not received the pharmaceutical composition.

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 fasting baseline non-HDL-C of about 200 mg/dl to about 300 mg/dl, a fasting baseline total cholesterol of about 250 mg/dl to about 300 mg/dl, a fasting baseline VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a fasting baseline HDL-C of about 10 mg/dl to about 80 mg/dl.

4. The method of claim 1, wherein the pharmaceutical composition, when administered for twelve weeks to a first patient population having said baseline triglyceride and LDL-C levels is effective to reduce apolipoprotein B in the first patient population compared to median apolipoprotien B levels observed in a second patient population having said baseline triglyceride and LDL-C levels who has not received the pharmaceutical composition.

5. The method of claim 1, wherein the pharmaceutical composition, when administered for twelve weeks to a first patient population having said baseline triglyceride and LDL-C is effective to reduce VLDL-C in the first patient population compared to median VLDL-C levels observed in a second patient population having said baseline triglyceride and LDL-C levels who has not received the pharmaceutical composition.

6. The method of claim 1, wherein the subject has a fasting baseline triglyceride level of 500 mg/dl to 1500 mg/d1.

7. The method of claim 1 wherein the pharmaceutical composition is present in one or more dosage units.

8. The method of claim 7 wherein the dosage units are capsules.