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Claims for Patent: 8,445,013

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Claims for Patent: 8,445,013

Title:Stable pharmaceutical composition and methods of using same
Abstract: The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.
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:13/614,129
Patent Claims: 1. A method of reducing triglycerides in a subject with fasting baseline triglycerides of at least about 500 mg/dl comprising, orally administering daily for a period of 12 weeks to the subject a pharmaceutical composition comprising 2000 mg to about 5000 mg of ethyl eicosapentaenoate, present in one or more capsules, to reduce triglycerides in the subject by at least about 20% compared to a second subject with fasting baseline triglycerides of at least about 500 mg/dl who has not received the pharmaceutical composition.

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

3. The method of claim 1, wherein the subject and the second subject have 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, and/or a median baseline fasting HDL-C of about 10 mg/d1 to about 80 mg/dl.

4. The method of claim 1, comprising administering to the subject the pharmaceutical composition daily for the period of 12 weeks to effect a reduction in triglycerides of at least about 25% without increasing LDL-C in the subject compared to the second subject.

5. The method of claim 1, comprising administering to the subject the pharmaceutical composition daily for the period of 12 weeks to effect a reduction in triglycerides of at least about 30% without increasing LDL-C in the subject compared to the second subject.

6. The method of claim 1, comprising administering to the subject the pharmaceutical composition daily for the period of 12 weeks to effect a reduction in VLDL-C in the subject compared to the second subject.
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