Details for Patent: 8,617,593
✉ Email this page to a colleague
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: | Feb 15, 2013 |
Application Number: | 13/768,869 |
Claims: | 1. A method of treating hypertriglyceridemia in a subject on statin therapy comprising, administering to the subject daily a pharmaceutical composition comprising about 2500 mg to about 5000 mg of ethyl eicosapentaenoate and not more than about 5% docosahexaenoic acid or its esters, by weight of all fatty acids. 2. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in LDL-C of at least 5% compared to placebo control. 3. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting triglycerides of at least 15% compared to baseline. 4. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting apolipoprotein B compared to baseline. 5. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting VLDL-C compared to baseline. 6. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting VLDL-C of at least 5% compared to baseline. 7. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in hs-CRP compared to baseline. 8. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in non-HDL-C compared to baseline. 9. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in total cholesterol compared to baseline. 10. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in non-HDL-C, triglycerides and VLDL-C compared to baseline. 11. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in oxidized LDL-C compared to baseline. 12. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in lipoprotein associated phospholipase A2 compared to baseline. 13. The method of claim 1 wherein the ethyl eicosapentaenoate is administered to the subject in dosage units each comprising about 500 mg to about 1.5 g of ethyl eicosapentaenoate. 14. The method of claim 13 wherein the dosage units are capsules. 15. The method of claim 1 wherein the ethyl eicosapentaenoate is administered to the subject in dosage units each comprising about 900 mg to about 1 g of ethyl eicosapentaenoate. 16. The method of claim 15 wherein the dosage units are capsules. 17. The method of claim 1 wherein the ethyl eicosapentaenoate is administered to the subject in dosage units each comprising about 1 g of ethyl eicosapentaenoate. 18. The method of claim 17 wherein the dosage units are capsules. 19. The method of claim 1 wherein the ethyl eicosapentaenoate comprises at least about 90%, by weight, of all fatty acids. 20. The method of claim 1 wherein the fatty acid composition is added to the statin administration after the statin administration has been deemed inadequate. |