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 lowering non-HDL-C in a subject having triglycerides of 200 mg/dl or greater who is receiving statin therapy comprising, administering to the subject daily for a period effective to reduce non-HDL-C in the subject a pharmaceutical composition comprising:
an amount of eicosapentaenoic acid selected from the group consisting of about 1100 mg, about 1650 mg and about 2200 mg; and
not more than about 20% docosahexaenoic acid, by weight of fatty acids present, for a period effective to reduce non-HDL-C in the subject.
2. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce non-HDL-C by at least about 3% in the subject.
3. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce non-HDL-C by at least about 5% in the subject.
4. The method of claim 2 wherein the reduction is relative to placebo control.
5. The method of claim 3 wherein the reduction is relative to placebo control.
6. The method of claim 2 wherein the reduction is relative to a baseline non-HDL-C level in the subject.
7. The method of claim 3 wherein the reduction is relative to a baseline non-HDL-C level in the subject.
8. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to decrease triglycerides in the subject.
9. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to increase HDL-C in the subject.
10. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce total cholesterol in the subject.
11. The method of claim 1 wherein the eicosapentaenoic acid is present in an amount of about 1100 mg.
12. The method of claim 1 wherein the eicosapentaenoic acid is present in an amount of about 1650 mg.
13. The method of claim 1 wherein the eicosapentaenoic acid is present in an amount of about 2200 mg.
14. The method of claim 1 wherein the pharmaceutical composition comprises less than about 20% docosahexaenoic acid, by weight of total fatty acids.
15. The method of claim 1 wherein the period is at least about 12 weeks.
16. The method of claim 1 wherein the composition is administered to the subject in one or more dosage units per day.