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 triglycerides in a subject having triglycerides of about 200 mg/dl to less than 500 mg/dl who is receiving statin therapy comprising, administering from 2000 mg to about 5000 mg to the subject daily a pharmaceutical composition comprising at least 96% pure ethyl-EPA for a period of at least about 4 weeks, and wherein the period is effective to lower fasting triglycerides in the subject compared to a fasting triglyceride level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period.
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 increase HDL-C in the subject.
9. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce total cholesterol in the subject.
10. The method of claim 1 wherein the pharmaceutical composition comprises less than about 20% docosahexaenoic acid, by weight of total fatty acids.
11. The method of claim 1 wherein the period is at least about 12 weeks.
12. The method of claim 1 wherein the composition is administered to the subject in one or more dosage units per day.