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Details for Patent: 8,324,195

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Details for Patent: 8,324,195

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)
Filing Date:Jan 12, 2012
Application Number:13/349,150
Claims:1. A method of reducing high-sensitivity C-reactive protein and triglycerides in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl, who does not receive a concurrent lipid altering therapy, comprising administering orally to the subject about 4 g per day of a pharmaceutical composition comprising at least about 96% by weight, ethyl eicosapentaenoate (ethyl-EPA) and substantially no docosahexaenoic acid (DHA) or its esters for a period of at least 12 weeks to effect a reduction in high-sensitivity C-reactive protein and triglycerides in the subject compared to a group of subjects having a median fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl, who do not receive a concurrent lipid altering therapy, and who have not received the pharmaceutical composition.

2. The method of claim 1, wherein the subject has a fasting baseline triglyceride level of 750 mg/dl to about 1500 2000 mg/dl.

3. The method of claim 1, wherein the subject is diabetic.

4. The method of claim 1 comprising administering the pharmaceutical composition to the subject daily for a period of at least 12 weeks to effect a reduction in high-sensitivity C-reactive protein of at least about 10% compared to the group of subjects.

5. The method of claim 1 comprising administering the pharmaceutical composition to the subject daily for a period of at least 12 weeks to effect a reduction in high-sensitivity C-reactive protein of at least about 20% compared to the group of subjects.

6. The method of claim 5 wherein the subject exhibits at least a 35% reduction in fasting triglycerides and no statistically significant increase in LDL-C compared to a baseline triglyceride and LDL-C level prior to initial administration of the pharmaceutical composition.

7. The method of claim 1 wherein the subject exhibits at least a 10% reduction in high-sensitivity C-reactive protein after the period of at least 12 weeks compared to a baseline high-sensitivity C-reactive protein level prior to initial administration of the pharmaceutical composition.

8. The method of claim 1 wherein the subject exhibits at least a 20% reduction in high-sensitivity C-reactive protein after the period of at least 12 weeks compared to a baseline high-sensitivity C-reactive protein level prior to initial administration of the pharmaceutical composition.

9. The method of claim 1, wherein comprising administering to effect a reduction in apolipoprotein B without increasing LDL C compared to the group of subjects.

10. The method of claim 1, wherein about one gram of the pharmaceutical composition is present in each of four capsules.

11. The method of claim 10, wherein 2 of the capsules are administered to the subject twice each day.

12. The method of claim 1, wherein the subject and the second subject consume a Western diet.

13. The method of claim 1, wherein the concomitant lipid-altering therapy is a statin.

14. The method of claim 1 comprising administering the pharmaceutical composition to the subject to effect a reduction in triglycerides of at least 15% in the subject compared to the group of subjects.
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