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 first group of subjects having a median fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl comprising: administering orally to the subjects 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 at least about 12 weeks to effect a reduction in triglycerides without substantially increasing LDL-C compared to a second group of subjects having a median fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl who have not received the pharmaceutical composition and a concurrent lipid altering therapy.
2. The method of claim 1 , wherein the pharmaceutical composition is administered to members of the group of subjects and the second group of subjects 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 first and second groups of subjects have a median fasting baseline LDL-C from about 40 mg/dl to about 115 mg/dl.
5. The method of claim 1 , wherein the first and second groups of subjects have 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 members of the first group of subjects 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 the second group of subjects.
7. The method of claim 1 , comprising administering to members of the first group of subjects 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 the second group of subjects.
8. The method of claim 1 , comprising administering to the first group of subjects 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 the second group of subjects.
9. The method of claim 1 , comprising administering to the first group of subjects 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 the second group of subjects.