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Last Updated: April 18, 2024

Details for Patent: 8,314,086


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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 (Birmingham, 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:Oct 28, 2011
Application Number:13/284,408
Claims:1. A method of reducing VLDL-C 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 VLDL-C and triglycerides in the subject compared to VLDL-C and triglycerides in a second 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, and who has not received the pharmaceutical composition.

2. The method of claim 1, wherein the pharmaceutical composition is administered to the subject 1 to 4 times per day.

3. The method of claim 1, wherein the pharmaceutical composition is present in one or more capsules.

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 VLDL-C of at least about 5% in the subject compared to VLDL-C in the second subject.

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 VLDL-C of at least about 10% in the subject compared to VLDL-C in the second subject.

6. 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 VLDL-C of at least about 15% compared to VLDL-C in the second subject.

7. The method of claim 1 comprising administering 4 g of the pharmaceutical composition to the subject daily for a period of at least 12 weeks to effect a reduction in VLDL-C of at least about 20% compared to VLDL-C in the second subject.

8. The method of claim 1 comprising administering 4 g of the pharmaceutical composition to the subject daily for a period of at least 12 weeks to effect a reduction in VLDL-C of at least about 25% compared to a VLDL-C in the second subject the pharmaceutical composition.

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

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

11. The method of claim 1, wherein said administering does not raise LDL-C or apolipoprotein B compared to LDL-C or apolipoprotein B in the second subject.

12. The method of claim 1 comprising administering the pharmaceutical composition to the subject to effect a reduction in triglycerides of at least about 15% in the subject compared to the second subject.

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