STABLE PHARMACEUTICAL COMPOSITION AND METHODS OF USING SAME
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.