Methods of treating hypertriglyceridemia
View Patent ↗In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
1. A method of reducing triglycerides and apolipoprotein B in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl, who does not receive a concurrent lipid altering therapy, comprising administering orally to the subject about 4 g per day of a pharmaceutical composition comprising at least about 96% by weight, ethyl eicosapentaenoate (ethyl-EPA) and substantially no docosahexaenoic acid (DHA) or its esters for a period of at least 12 weeks to effect a reduction in triglycerides and apolipoprotein B in the subject compared to a triglyceride level and apolipoprotein B level in a second subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl, who does not receive a concurrent lipid altering therapy, and who has not received the pharmaceutical composition.
2. The method of claim 1 wherein the composition is administered to the subject 1 to 4 times per day.
3. The method of claim 1 wherein the composition is present in one or more capsules.
4. The method of claim 1 comprising administering the composition to the subject daily for a period of 12 weeks to effect a reduction in apolipoprotein B and substantially no increase in LDL-C levels compared to the second subject.
5. The method of claim 1 comprising administering 4 g of the composition to the subject daily for a period of 12 weeks to effect at least a 5% reduction in triglyceride levels compared to a triglyceride level in the second subject.
6. The method of claim 1 comprising administering 4 g of the composition to the subject daily for a period of 12 weeks to effect at least a 5% reduction in VLDL-C levels compared to a VLDL-C level in the second subject.
7. The method of claim 1 comprising administering 4 g of the composition to the subject daily for a period of 12 weeks to effect a reduction in non-HDL-C levels compared to a non-HDL-C level in the second subject.
8. The method of claim 1 comprising administering 4 g of the composition to the subject daily for a period of 12 weeks to effect a reduction in triglycerides of at least about 25% and a reduction in non-HDL C of at least about 5% as compared to the second subject.
9. The method of claim 1 comprising administering 4 g of the composition to the subject daily for a period of 12 weeks to effect a reduction in Lp-PLA2 of at least about 15% as compared a Lp-PLA2 level in the second subject.
10. The method of claim 9 comprising administering 4 g of the composition to the subject daily for a period of 12 weeks to effect a reduction in total cholesterol of at least about 15% as compared a total cholesterol level in the second subject.
11. The method of claim 1 wherein the subject and the second subject consume a Western diet.
12. The method of claim 1 wherein the concomitant lipid-altering therapy is a statin.
13. A method of reducing triglycerides in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl, who does not receive a concurrent lipid altering therapy, comprising administering orally to the subject about 4 g per day of a pharmaceutical composition comprising at least about 96% by weight, ethyl eicosapentaenoate (ethyl-EPA) and substantially no docosahexaenoic acid (DHA) or its esters for a period of at least 12 weeks to effect a statistically significant reduction in triglycerides without effecting a statistically significant increase in LDL-C or apolipoprotein B in the subject.
14. The method of claim 13 comprising administering to the subject about 4 g per day of the pharmaceutical composition to effect a statistically significant reduction in triglycerides and apolipoprotein B without effecting a statistically significant increase of in the subject.
15. The method of claim 13 wherein the subject and the second subject consume a Western diet.
16. The method of claim 13 wherein the concomitant lipid-altering therapy is a statin.
17. A method of reducing triglycerides and apolipoprotein B in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl, who does not receive a concurrent lipid altering therapy, comprising administering orally to the subject about 4 g per day of a pharmaceutical composition comprising at least about 96% by weight, ethyl eicosapentaenoate (ethyl-EPA) and substantially no docosahexaenoic acid (DHA) or its esters for a period of at least 12 weeks to effect reduction in triglycerides and apolipoprotein B in the subject compared to a triglyceride level and an apolipoprotein B level at a baseline prior to initial administration of the pharmaceutical composition.
18. The method of claim 17 wherein the subject and the second subject consume a Western diet.
19. The method of claim 17 wherein the concomitant lipid-altering therapy is a statin.