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 in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl comprising: administering orally to the subject about 4 g per day of a pharmaceutical composition comprising at least about 96%, by weight of all fatty acids present, ethyl eicosapentaenoate and substantially no docosahexaenoic acid or its esters for a period of about 12 weeks to effect a reduction in triglycerides without substantially increasing LDL-C compared to baseline.
2. The method of claim 1 , wherein the pharmaceutical composition is administered to the subject 1 to 4 times per day.
3. The method of claim 2 , wherein the pharmaceutical composition is present in one or more capsules.
4. The method of claim 1 , wherein the subject has a fasting baseline LDL-C from about 40 mg/dl to about 115 mg/dl.
5. The method of claim 1 , wherein subject has one or more of: a median baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a median baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a median baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a median baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.
6. The method of claim 1 , comprising administering to the subject about 4 g of the pharmaceutical composition daily for the period of at least about 12 weeks to effect a reduction in fasting triglycerides of at least about 10% without substantially increasing LDL-C compared to baseline.
7. The method of claim 1 , comprising administering to the subject about 4 g of the pharmaceutical composition daily for the period of at least about 12 weeks to effect a reduction in fasting triglycerides of at least about 25% without substantially increasing LDL-C compared to baseline.
8. The method of claim 1 , comprising administering to the subject about 4 g of the pharmaceutical composition daily for the period of at least about 12 weeks to effect a reduction in apolipoprotein B compared to baseline.
9. The method of claim 1 , comprising administering to the subject about 4 g of the pharmaceutical composition daily for the period of at least about 12 weeks to effect a reduction in VLDL-C compared to baseline.
10. A method of lowering triglycerides in a subject having a fasting baseline triglyceride level of about 500 mg/dl to about 1500 mg/dl comprising: administering orally to the subject about 4 g per day of a pharmaceutical composition comprising at least about 96%, by weight of all fatty acids present, ethyl eicosapentaenoate and substantially no docosahexaenoic acid or its esters, which when orally administered in a first patient population having said baseline triglyceride level and receiving, for a period of twelve weeks, 4 g per day of the pharmaceutical composition, is effective to reduce said baseline triglyceride level without substantially increasing LDL-C compared to a second patient population having said baseline triglyceride level that has not received the pharmaceutical composition.
11. The method of claim 10 , wherein the pharmaceutical composition is administered to the subject 1 to 4 times per day.
12. The method of claim 11 , wherein the pharmaceutical composition is present in one or more capsules.
13. The method of claim 10 , wherein the subject has a fasting baseline LDL-C from about 40 mg/dl to about 115 mg/dl.
14. The method of claim 10 , wherein subject has one or more of: a median baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a median baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a median baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a median baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.
15. The method of claim 10 , wherein the pharmaceutical composition, when orally administered daily to the first patient population for the period of twelve weeks is effective to reduce the baseline triglyceride level by at least about 10% without substantially increasing LDL-C compared to the second patient population that has not received the pharmaceutical composition.
16. The method of claim 10 , wherein the pharmaceutical composition, when orally administered daily to the first patient population for the period of twelve weeks is effective to reduce the baseline triglyceride level by at least about 25% without substantially increasing LDL-C compared to the second patient population that has not received the pharmaceutical composition.
17. The method of claim 10 , wherein the pharmaceutical composition, when orally administered daily to the first patient population for the period of twelve weeks is effective to reduce apolipoprotein B compared to the second patient population that has not received the pharmaceutical composition.
18. The method of claim 10 , wherein the pharmaceutical composition, when orally administered daily to the first patient population for the period of twelve weeks is effective to reduce VLDL-C compared to the second patient population that has not received the pharmaceutical composition.