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 having a fasting baseline triglyceride level of 500 mg/dl to about 2000 mg/dl comprising administering to the subject about 2 g to about 4 g per day of a pharmaceutical composition comprising at least about 96%, by weight, ethyl eicosapentaenoate for a period effective to reduce triglycerides in the subject. 
     
     
         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 2  wherein the composition is present in one or more capsules. 
     
     
         4 . The method of  claim 1  wherein said period is about 1 to about 12 weeks. 
     
     
         5 . The method of  claim 1  wherein said period is about 1 to about 10 weeks. 
     
     
         6 . The method of  claim 1  wherein said period is about 1 to about 5 weeks. 
     
     
         7 . The method of any one of  claims 4 - 6  wherein the subject has 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 a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl. 
     
     
         8 . The method of  claim 7  wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for said period, the subject further exhibits (a) a reduction in fasting non-HDL-C compared to a fasting non-HDL-C level at a baseline prior to initial administration of the pharmaceutical composition; and (b) a reduction in fasting VLDL-C compared to a fasting VLDL-C level at a baseline prior to initial administration of the pharmaceutical composition. 
     
     
         9 . The method of  claim 8  wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for the period the subject exhibits: (a) a reduction in fasting triglycerides of at least about 25% compared to a fasting triglyceride level at a baseline prior to initial administration of the pharmaceutical composition; (b) a reduction in fasting non-HDL-C of at least about 5% compared to a fasting non-HDL-C level at a baseline prior to initial administration of the pharmaceutical composition; and (c) substantially no increase in LDL-C compared to a fasting LDL-C level at a baseline prior to initial administration of the pharmaceutical composition. 
     
     
         10 . A method of reducing triglycerides in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 2000 mg/dl and that is not on statin therapy, the method comprising administering to the subject about 4 g per day of a pharmaceutical composition comprising at least about 96%, by weight, ethyl eicosapentaenoate for a period effective to reduce fasting triglycerides by at least about 25% without substantially increasing LDL-C compared to a fasting triglyceride level and LDL-C level at a baseline prior to initial administration of the pharmaceutical composition. 
     
     
         11 . The method of  claim 10  wherein said period is about 1 to about 12 weeks. 
     
     
         12 . The method of  claim 10  wherein said period is about 1 to about 10 weeks. 
     
     
         13 . The method of  claim 10  wherein said period is about 1 to about 5 weeks. 
     
     
         14 . The method of any one of  claims 12 - 14  wherein the composition is administered to the subject 1 to 4 times per day. 
     
     
         15 . The method of  claim 14  wherein the composition is present in one or more capsules. 
     
     
         16 . The method of  claim 14  wherein the subject has 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 a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl. 
     
     
         17 . The method of  claim 16  wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for said period, the subject further exhibits (a) a reduction in fasting non-HDL-C levels compared to a fasting non-HDL-C level at a baseline prior to initial administration of the pharmaceutical composition; and (b) a reduction in fasting VLDL-C compared to a fasting VLDL-C level at a baseline prior to initial administration of the pharmaceutical composition. 
     
     
         18 . The method of  claim 14  wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for said period the subject exhibits: (a) a reduction in fasting triglycerides of at least about 25% compared to a fasting triglyceride level at a baseline prior to initial administration of the pharmaceutical composition; (b) a reduction in fasting non-HDL-C of at least 5% compared to a fasting non-HDL-C level at a baseline prior to initial administration of the pharmaceutical composition; and (c) a reduction in fasting LDL-C compared to a fasting LDL-C level at a baseline prior to initial administration of the pharmaceutical composition. 
     
     
         19 . The method of  claim 14  wherein the subject is not on a concomitant lipid altering therapy.