Stable pharmaceutical composition and methods of using same

Abstract

The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.

We claim: 
     
         1 . A method of lowering non-HDL-C in a subject having triglycerides of 200 mg/dl or greater who is receiving statin therapy comprising, administering to the subject daily for a period effective to reduce non-HDL-C in the subject a pharmaceutical composition comprising:
 an amount of eicosapentaenoic acid selected from the group consisting of about 1100 mg, about 1650 mg and about 2200 mg; and   not more than about 20% docosahexaenoic acid, by weight of fatty acids present, for a period effective to reduce non-HDL-C in the subject.   
     
     
         2 . The method of  claim 1  comprising, administering to the subject the pharmaceutical composition for a period effective to reduce non-HDL-C by at least about 3% in the subject. 
     
     
         3 . The method of  claim 1  comprising, administering to the subject the pharmaceutical composition for a period effective to reduce non-HDL-C by at least about 5% in the subject. 
     
     
         4 . The method of  claim 2  wherein the reduction is relative to placebo control. 
     
     
         5 . The method of  claim 3  wherein the reduction is relative to placebo control. 
     
     
         6 . The method of  claim 2  wherein the reduction is relative to a baseline non-HDL-C level in the subject. 
     
     
         7 . The method of  claim 3  wherein the reduction is relative to a baseline non-HDL-C level in the subject. 
     
     
         8 . The method of  claim 1  comprising, administering to the subject the pharmaceutical composition for a period effective to decrease triglycerides in the subject. 
     
     
         9 . The method of  claim 1  comprising, administering to the subject the pharmaceutical composition for a period effective to increase HDL-C in the subject. 
     
     
         10 . The method of  claim 1  comprising, administering to the subject the pharmaceutical composition for a period effective to reduce total cholesterol in the subject. 
     
     
         11 . The method of  claim 1  wherein the eicosapentaenoic acid is present in an amount of about 1100 mg. 
     
     
         12 . The method of  claim 1  wherein the eicosapentaenoic acid is present in an amount of about 1650 mg. 
     
     
         13 . The method of  claim 1  wherein the eicosapentaenoic acid is present in an amount of about 2200 mg. 
     
     
         14 . The method of  claim 1  wherein the pharmaceutical composition comprises less than about 20% docosahexaenoic acid, by weight of total fatty acids. 
     
     
         15 . The method of  claim 1  wherein the period is at least about 12 weeks. 
     
     
         16 . The method of  claim 1  wherein the composition is administered to the subject in one or more dosage units per day.