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Claims for Patent: 8,524,698

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Claims for Patent: 8,524,698

Title:Methods of treating hypertriglyceridemia
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.
Inventor(s): Manku; Mehar (England, GB), Osterloh; Ian (Kent, GB), Wicker; Pierre (Mystic, CT), Braeckman; Rene (Richboro, PA), Soni; Paresh (Mystic, CT)
Assignee: Amarin Pharmaceuticals Ireland Limited (Dublin, IE)
Application Number:13/776,249
Patent Claims: 1. A method of reducing triglycerides comprising, orally administering daily for a period of at least about 12 weeks 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, 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 apolipoprotein 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/dl.

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.
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