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 .- 16 . (canceled) 
     
     
         17 . A method of reducing triglyceride levels relative to baseline in a subject in need thereof having a plasma level of free EPA not greater than about 50 μg/ml, comprising administering a pharmaceutical composition comprising about 4 g of ethyl eicosapentaenoate and not more than about 4% docosahexaenoic acid or its esters, by weight of all fatty acids. 
     
     
         18 . The method of  claim 17  wherein the pharmaceutical composition is administered to the subject 1 to 4 times per day. 
     
     
         19 . The method of  claim 17 , wherein the pharmaceutical composition is present in one or more dosage units. 
     
     
         20 . The method of  claim 19 , wherein the one or more dosage units are capsules. 
     
     
         21 . The method of  claim 17 , wherein the subject is administered the pharmaceutical composition for at least about 12 weeks to effect a reduction in triglycerides in the subject. 
     
     
         22 . The method of  claim 17 , wherein the subject has a fasting baseline triglyceride level of 500 mg/dl to 1500 mg/dl. 
     
     
         23 . The method of  claim 22 , wherein the subject has one or more of a fasting baseline LDL-C from about 50 mg/dl to about 300 mg/dl, 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, or a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl. 
     
     
         24 . A method of reducing plasminogen activator inhibitor-1 levels and triglyceride levels relative to baseline in a subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising about 4 g of ethyl eicosapentaenoate and not more than about 4% docosahexaenoic acid or its esters, by weight of all fatty acids. 
     
     
         25 . The method of  claim 24 , wherein the pharmaceutical composition is administered to the subject 1 to 4 times per day. 
     
     
         26 . The method of  claim 24 , wherein the pharmaceutical composition is present in one or more dosage units. 
     
     
         27 . The method of  claim 26 , wherein the one or more dosage units are capsules. 
     
     
         28 . The method of  claim 24 , wherein the subject is administered the pharmaceutical composition for at least about 12 weeks to effect a reduction in plasminogen activator inhibitor-1 levels 
     
     
         29 . The method of  claim 24 , wherein the subject has a fasting baseline triglyceride level of 500 mg/dl to 1500 mg/dl. 
     
     
         30 . The method of  claim 29 , wherein the subject has one or more of a fasting baseline LDL-C from about 50 mg/dl to about 300 mg/dl, 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, or a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl. 
     
     
         31 . A method of reducing non-HDL-C levels and triglycerides relative to baseline in a subject having a fasting baseline triglyceride level of 500 mg/dl to 1500 mg/dl, comprising administering to the subject a pharmaceutical composition comprising about 4 g of ethyl eicosapentaenoate and not more than about 4% docosahexaenoic acid or its esters, by weight of all fatty acids. 
     
     
         32 . The method of  claim 31 , wherein the pharmaceutical composition is administered to the subject 1 to 4 times per day. 
     
     
         33 . The method of  claim 32 , wherein the pharmaceutical composition is present in one or more dosage units. 
     
     
         34 . The method of  claim 31 , wherein the dosage units are capsules. 
     
     
         35 . The method of  claim 31 , wherein the subject is administered the pharmaceutical composition for at least about 12 weeks to effect a reduction in non-HDL-C levels. 
     
     
         36 . The method of  claim 35 , wherein the subject has one or more of a fasting baseline LDL-C from about 50 mg/dl to about 300 mg/dl, 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, or a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.