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 reducing triglycerides in a subject having a fasting baseline triglyceride level of at least about 700 mg/dl, atrial fibrillation and/or atrial flutter, and on a statin therapy, the method comprising administering to the subject about 4 g of ethyl eicosapentaenoate per day. 
     
     
         2 . The method of  claim 1 , wherein the ethyl eicosapentaenoate is present in a pharmaceutical composition and the ethyl eicosapentaenoate comprises at least about 96 wt. % of all omega-3 fatty acids in the pharmaceutical composition. 
     
     
         3 . The method of  claim 2 , wherein about 1 g of the pharmaceutical composition is present in each of 4 capsules. 
     
     
         4 . The method of  claim 1 , wherein the subject has a baseline LDL-C level of about 40 mg/dL to about 100 mg/dL. 
     
     
         5 . The method of  claim 1 , wherein the subject is diabetic. 
     
     
         6 . The method of  claim 1 , wherein the subject exhibits at least about a 10% reduction in fasting triglycerides compared to a baseline triglyceride level. 
     
     
         7 . The method of  claim 6 , wherein the subject exhibits no statistically significant increase in LDL-C compared to an LDL-C level prior to initial administration of the ethyl eicosapentaenoate. 
     
     
         8 . The method of  claim 2 , wherein the statin therapy is a stable statin therapy. 
     
     
         9 . The method of  claim 2 , wherein the subject is administered the ethyl eicosapentaenoate for at least about 12 weeks. 
     
     
         10 . The method of  claim 2 , further comprising reducing a risk of stroke, myocardial infarction, or both in the subject.