Compositions and methods for lowering triglycerides

Abstract

In various embodiments, the present invention provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject in need thereof.

What is claimed is: 
     
         1 . A method of lowering triglycerides in a subject on stable statin therapy having type 2 diabetes mellitus and fasting triglycerides of about 200 mg/dl to less than 500 mg/dl comprising administering to the subject a composition comprising about 4 g per day of ethyl eicosapentaenoate for a period effective to reduce fasting triglycerides in the subject compared to a fasting triglyceride level in a subject having type 2 diabetes mellitus who is maintained on stable statin therapy without concomitant ethyl eicosapentaenoate therapy for said period. 
     
     
         2 . The method of  claim 1 , wherein the composition is administered to the subject 1 to 4 times per day. 
     
     
         3 . The method of  claim 2 , wherein the composition is present in one or more capsules. 
     
     
         4 . The method of  claim 1 , wherein the ethyl eicosapentaenoate represents at least about 80%, by weight, of all fatty acids present in the composition. 
     
     
         5 . The method of  claim 1 , wherein the composition contains not more than about 10% by weight of docosahexaenoic acid or derivatives thereof. 
     
     
         6 . The method of  claim 1 , wherein the step of administering is further effective to reduce an LDL-C level in the subject compared to an LDL-C level in the subject having type 2 diabetes mellitus who is maintained on stable statin therapy without concomitant ethyl eicosapentaenoate therapy for said period. 
     
     
         7 . The method of  claim 1 , wherein the step of administering is further effective to reduce a non-HDL-C level in the subject compared to a non-HDL-C level in the subject having type 2 diabetes mellitus who is maintained on stable statin therapy without concomitant ethyl eicosapentaenoate therapy for said period. 
     
     
         8 . The method of  claim 1 , wherein the step of administering is further effective to reduce an ApoB level in the subject compared to an ApoB level in the subject having type 2 diabetes mellitus who is maintained on stable statin therapy without concomitant ethyl eicosapentaenoate therapy for said period. 
     
     
         9 . The method of  claim 1 , wherein the period is about 1 week to about 12 weeks. 
     
     
         10 . The method of  claim 1 , wherein the period is about 12 weeks. 
     
     
         11 . The method of  claim 1 , wherein the step of administering is further effective to reduce an LDL-C level, a non-HDL-C level, and an ApoB level in the subject compared to an LDL-C level, a non-HDL-C level, and an ApoB level, respectively, in the subject having type 2 diabetes mellitus who is maintained on stable statin therapy without concomitant ethyl eicosapentaenoate therapy for said period. 
     
     
         12 . The method of  claim 11 , wherein the step of administering is further effective to reduce the triglycerides by at least about 20%, the LDL-C level by at least about 5%, the non-HDL-C level by at least about 10%, and the ApoB level by at least about 5% in the subject compared to the triglyceride level, the LDL-C level, the non-HDL-C level, and the ApoB level, respectively, in the subject having type 2 diabetes mellitus who is maintained on stable statin therapy without concomitant ethyl eicosapentaenoate therapy for said period. 
     
     
         13 . The method of  claim 1  wherein the subject has a baseline fasting LDL-C level of 40 mg/dl to 100 mg/dl and a fasting triglyceride level of 200 mg/dl to 500 mg/dl immediately prior to initial administration of the pharmaceutical composition. 
     
     
         14 . The method of  claim 1 , wherein the step of administering is further effective to increase LDL particle size in the subject compared to an LDL particle size in the subject having type 2 diabetes mellitus who is maintained on stable statin therapy without concomitant ethyl eicosapentaenoate therapy for said period. 
     
     
         15 . The method of  claim 1 , wherein the step of administering is further effective to reduce an LDL particle number by at least about 5% in the subject compared to an LDL particle number in the subject having type 2 diabetes mellitus who is maintained on stable statin therapy without concomitant ethyl eicosapentaenoate therapy for said period.