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Details for Patent: 8,454,994

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Details for Patent: 8,454,994

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)
Filing Date:Sep 13, 2012
Application Number:13/614,111
Claims:1. A method of treating mixed dyslipidemia in a subject on statin therapy comprising, administering to the subject 2500 mg to 5000 mg daily of fatty acids, at least about 95% by weight of which are ethyl eicosapentaenoate, wherein upon 12 weeks of said administration the subject exhibits a reduction in triglycerides of at least 15% and a reduction in LDL-C of at least 5% compared to placebo control.

2. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting triglycerides of at least 20% compared to placebo control.

3. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting apolipoprotein B compared to placebo control.

4. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting VLDL-C compared to placebo control.

5. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting VLDL-C of at least 10% compared to placebo control.

6. The method of claim 1 where the ethyl eicosapentaenoate is administered to the subject in capsules each comprising about 900 mg to about 1 g of ethyl eicosapentaenoate.

7. The method of claim 1 where the ethyl eicosapentaenoate is administered to the subject in capsules each comprising about 1 g of ethyl eicosapentaenoate.
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