Methods of treating hypertriglyceridemia

Abstract

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 in need thereof comprising: administering to the subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl about 2 g to per day of a pharmaceutical composition comprising at least about 90%, by weight, ethyl eicosapentaenoate for a period of 12 weeks to effect a reduction in triglycerides compared to a second subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl who has not received the pharmaceutical composition. 
     
     
         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 and the second subject have one or more of: a baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl. 
     
     
         5 . The method of  claim 4 , comprising administering to the subject about 2 g of the pharmaceutical composition daily for the period of  12  weeks to effect a reduction in fasting non-HDL-C and a reduction in fasting VLDL-C compared to the second subject. 
     
     
         6 . The method of  claim 4 , comprising administering to the subject about 2 g of the pharmaceutical composition daily for the period of 12 weeks to effect a reduction in fasting triglycerides of at least about 15% compared to the second subject. 
     
     
         7 . A method of reducing triglycerides in a subject with very high triglycerides and in need thereof comprising, administering to the subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl who does not receive concurrent lipid altering therapy about 2 g per day of a pharmaceutical composition comprising at least about 90%, by weight, ethyl eicosapentaenoate for a period of 12 weeks to effect a reduction in fasting triglycerides of at least about 15% without increasing LDL-C compared to a second subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl who does not receive concurrent lipid altering therapy or the pharmaceutical composition. 
     
     
         8 . The method of  claim 8 , wherein the pharmaceutical composition is administered to the subject 1 to 4 times per day. 
     
     
         9 . The method of  claim 9 , wherein the pharmaceutical composition is present in one or more capsules. 
     
     
         10 . The method of  claim 8 , wherein the subject and the second subject have one or more of: a baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl. 
     
     
         11 . The method of  claim 10 , comprising administering to the subject about 2 g of the pharmaceutical composition daily for the period of 12 weeks to effect a reduction in fasting non-HDL-C and a reduction in fasting VLDL-C compared to the second subject. 
     
     
         12 . The method of  claim 11 , comprising administering to the subject about 2 g of the pharmaceutical composition daily for the period of 12 weeks to effect a reduction in fasting triglycerides of at least about 15% compared to the second subject. 
     
     
         13 . The method of  claim 1 , wherein the subject and the second subject consume a Western diet. 
     
     
         14 . The method of  claim 1 , wherein the subject and the second subject do not receive a concurrent lipid altering therapy. 
     
     
         15 . The method of  claim 14 , wherein the concurrent lipid altering therapy comprises a statin. 
     
     
         16 . The method of  claim 7 , wherein the concurrent lipid altering therapy comprises a statin. 
     
     
         17 . The method of  claim 16 , wherein the subject and the second subject consume a Western diet. 
     
     
         18 . The method of  claim 17 , wherein the pharmaceutical composition comprises not more than about 0.6% by weight of any individual fatty acid other than ethyl-EPA.