Methods of reducing the risk of a cardiovascular event in a subject on statin therapy

Abstract

In various embodiments, the present invention provides methods of reducing the risk of a cardiovascular event in a subject on statin therapy and, in particular, a method of reducing the risk of a cardiovascular event in a subject on statin therapy having a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL, and administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof.

What is claimed is: 
     
         1 . A method of reducing risk of a cardiovascular event in a subject on statin therapy with established cardiovascular disease, the method comprising administering to the subject about 4 g of eicosapentaenoic acid per day for a period effective to reduce risk of the cardiovascular event. 
     
     
         2 . The method of  claim 1 , wherein the cardiovascular event is selected from the group consisting of cardiovascular death, coronary revascularization, unstable angina, myocardial infarction, and stroke. 
     
     
         3 . The method of  claim 1 , wherein the subject is on a stable statin therapy. 
     
     
         4 . The method of  claim 1 , wherein subject has a baseline triglyceride level of at least 200 mg/dL. 
     
     
         5 . The method of  claim 1 , wherein the eicosapentaenoic acid present in a pharmaceutical composition and the eicosapentaenoic acid comprises at least about 96 wt. % of all omega-3 fatty acids in the pharmaceutical composition. 
     
     
         6 . The method of  claim 5 , wherein about 1 g of the pharmaceutical composition is present in each of 4 capsules. 
     
     
         7 . A method of reducing a risk of a cardiovascular event in a subject on statin therapy, the method comprising administering about 4 g per day of eicosapentaenoic acid to the subject for a period effective to reduce the risk of a cardiovascular event, wherein the subject is 50 years of age or older, has diabetes and at least one additional risk factor for cardiovascular disease. 
     
     
         8 . The method of  claim 7 , wherein the at least one additional risk factor is selected from hypertension, smoking, retinopathy and albuminuria. 
     
     
         9 . The method of  claim 7 , wherein the subject has at least two additional risk factors for cardiovascular disease. 
     
     
         10 . The method of  claim 7 , wherein subject has a baseline triglyceride level of at least about 135 mg/dL. 
     
     
         11 . The method of  claim 7 , wherein the major adverse cardiovascular event is selected from the group consisting of stroke, myocardial infarction, coronary revascularization, unstable angina and cardiovascular death. 
     
     
         12 . The method of  claim 1 , wherein the statin therapy is a stable statin therapy. 
     
     
         13 . The method of  claim 1 , wherein the eicosapentaenoic acid present in a pharmaceutical composition and the eicosapentaenoic acid comprises at least about 96 wt. % of all omega-3 fatty acids in the pharmaceutical composition. 
     
     
         14 . The method of  claim 13 , wherein about 1 g of the pharmaceutical composition is present in each of 4 capsules.