Pharmaceutical compositions comprising epa and a cardiovascular agent and methods of using the same

Abstract

The present invention relates to, inter alia, pharmaceutical compositions comprising EPA and one or more cardiovascular agents, and to therapeutic methods for treating various diseases and disorders using the same.

What is claimed is: 
     
         1 . A method of treating a subject having baseline fasting triglycerides of at least 500 mg/dl comprising, administering to the subject an HMG-CoA reductase inhibitor and 4 g per day of a pharmaceutical composition comprising at least 96% by weight ethyl eicosapentaenoate for a period effective to reduce fasting triglycerides by at least 45% without substantially increasing LDL-C relative to a control subject taking a concomitant HMG-CoA reductase inhibitor without said pharmaceutical composition. 
     
     
         2 . The method of  claim 1  wherein said period is a period effective to reduce fasting triglycerides by at least 50% without substantially increasing LDL-C relative to a control subject taking a concomitant HMG-CoA reductase inhibitor without said pharmaceutical composition. 
     
     
         3 . The method of  claim 1  wherein said period is a period effective to reduce fasting triglycerides by at least 55% without substantially increasing LDL-C relative to a control subject taking a concomitant HMG-CoA reductase inhibitor without said pharmaceutical composition. 
     
     
         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 12 weeks. 
     
     
         6 . The method of  claim 1  wherein the composition is administered to the subject 1 to 4 times per day. 
     
     
         7 . The method of  claim 6  wherein the composition is present in one or more capsules. 
     
     
         8 . The method of  claim 1  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, a baseline fasting LDL-C of about 40 mg/dl to about 115 mg/dl and a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl. 
     
     
         9 . The method of  claim 8  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. 
     
     
         10 . The method of  claim 1  wherein the HMG-CoA reductase inhibitor comprises rosuvastatin, atorvastatin or pravastatin.