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Claims for Patent: 8,563,608

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Claims for Patent: 8,563,608

Title:Methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Abstract: The present invention relates to methods of reducing triglyceride levels in statin-treated subjects having a triglyceride level of 500 mg/dl to 1500 mg/dl.
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:13/417,899
Patent Claims: 1. A method of reducing triglyceride levels in a subject on statin therapy and having a triglyceride level of 500 mg/dl to 1500 mg/dl comprising, administering to the subject 2000 mg to 5000 mg per day of ethyl eicosapentaenoate for 12 weeks to reduce triglycerides in the subject without substantially increasing LDL-C compared to subjects having a triglyceride level of 500 mg/dl to 1500 mg/dl who receive a statin but no ethyl eicosapentaenoate for 12 weeks.

2. The method of claim 1, wherein the triglycerides in the subject are reduced by at least 30% compared to subjects having a triglyceride level of 500 mg/dl to 1500 mg/dl who receive a statin but no ethyl eicosapentaenoate for 12 weeks.

3. The method of claim 1, wherein the triglycerides in the subject are reduced by at least 40% compared to subjects having a triglyceride level of 500 mg/dl to 1500 mg/dl who receive a statin but no ethyl eicosapentaenoate for 12 weeks.

4. The method of claim 1, wherein the triglycerides in the subject are reduced by at least 50% compared to subjects having a triglyceride level of 500 mg/dl to 1500 mg/dl who receive a statin but no ethyl eicosapentaenoate for 12 weeks.

5. The method of claim 1, wherein the statin is selected from lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin, fluvastatin, atorvastatin and simvastatin.

6. The method of claim 1, wherein the 2000 mg to 5000 mg of ethyl eicosapentaenoate is administered to the subject in 4 capsules.

7. The method of claim 6, wherein the capsules each comprises about 900 mg to about 1 g of ethyl eicosapentaenoate.

8. The method of claim 1, wherein the 2000 mg to 5000 mg of ethyl eicosapentaenoate is administered in a plurality of capsules providing a daily ethyl eicosapentaenoate dose of 2000 mg to 5000 mg.

9. The method of claim 1, wherein the 2000 mg to 5000 mg of ethyl eicosapentaenoate is administered to the subject in 4 capsules each comprising about 1 g of ethyl eicosapentaenoate.
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