Stable pharmaceutical composition and methods of using same
View Patent ↗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.
1. A method of reducing triglycerides in a subject with mixed dyslipidemia on statin therapy comprising, administering to the subject a pharmaceutical composition comprising about 2500 mg to 5000 mg per day of ethyl eicosapentaenoate and not more than about 5%, by weight of all fatty acids, docosahexaenoic acid or its esters to effect a reduction in fasting triglyceride levels in the subject.
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 the subject exhibits a reduction in fasting triglycerides of at least 15% compared to placebo control.
4. 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.
5. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting triglycerides of at least 25% compared to placebo control.
6. The method of claim 1 wherein the subject exhibits a reduction in fasting VLDL-C compared to placebo control.
7. The method of claim 1 wherein the subject exhibits a reduction in fasting VLDL-C of at least 5% compared to placebo control.
8. The method of claim 1 wherein the subject exhibits a reduction in hs-CRP compared to placebo control.
9. The method of claim 1 wherein the subject exhibits a reduction in non-HDL-C compared to placebo control.
10. The method of claim 1 wherein the subject exhibits a reduction in total cholesterol compared to placebo control.
11. The method of claim 1 wherein the subject exhibits a reduction in non-HDL-C, total cholesterol and VLDL-C compared to placebo control.
12. The method of claim 1 wherein the subject exhibits a reduction in oxidized LDL-C compared to placebo control.
13. The method of claim 1 wherein the subject exhibits a reduction in lipoprotein associated phospholipase A2 compared to placebo control.
14. 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.
15. The method of claim 14 wherein the dosage units are capsules.
16. 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.
17. The method of claim 16 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.