Compositions and methods for lowering levels of high-sensitivity (hs-crp) in a subject

Abstract

The present disclosure provides methods for treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof. In some embodiments, the method comprises lowering high sensitivity CRP (hs-CRP) levels in a subject including, for example, a subject with a HbA 1c value of about 5.00% 8.50% or at least about 6.8%.

What is claimed is: 
     
         1 . A method of treating or preventing a cardiovascular disease in a subject having diabetes or at risk of developing diabetes, the method comprising administering to the subject a pharmaceutical composition comprising about 4 g of eicosapentaenoic acid ethyl ester per day, wherein the pharmaceutical composition is administered to the subject for a period of time effective to reduce a baseline hemoglobin A 1c  (HbA 1c ) level and/or baseline high-sensitivity C reactive protein (hs-CRP) level in the subject. 
     
     
         2 . The method of  claim 1 , wherein the subject has a baseline hs-CRP level of about 2 mg/L. 
     
     
         3 . The method of  claim 1 , wherein the subject has a baseline HbA 1c  level of at least about 6.8%. 
     
     
         4 . The method of  claim 1 , wherein the subject has a baseline triglyceride level of about 135 to about 500 mg/dl. 
     
     
         5 . The method of  claim 1 , wherein the subject maintains or improves glycemic control after administration of the pharmaceutical composition. 
     
     
         6 . The method of  claim 1 , wherein the period of time is about 12 weeks and the baseline hs-CRP level and/or baseline HbA 1c  level is reduced in the subject by at least about 5%. 
     
     
         7 . The method of  claim 1 , wherein the baseline HbA 1c  level and/or baseline hs-CRP level of the subject is reduced by at least about 10% after administration of the pharmaceutical composition. 
     
     
         8 . The method of  claim 1 , wherein the reduction in baseline hemoglobin A 1c  (HbA 1c ) level and/or baseline high-sensitivity C reactive protein (hs-CRP) level in the subject is relative to hemoglobin A 1c  (HbA 1c ) and/or high-sensitivity C reactive protein (hs-CRP) levels in a placebo controlled subject who is on stable statin therapy and has not received the pharmaceutical composition. 
     
     
         9 . The method of  claim 1 , wherein the subject is on statin therapy or stable statin therapy. 
     
     
         10 . The method of  claim 9 , wherein the statin is selected from the group consisting of atorvastatin, rosuvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, fluvastatin, and simvastatin. 
     
     
         11 . The method of  claim 1 , wherein the pharmaceutical composition comprises at least about 90%, by weight of all fatty acids present, eicosapentaenoic acid ethyl ester. 
     
     
         12 . The method of  claim 1 , wherein the pharmaceutical composition is encapsulated in a capsule. 
     
     
         13 . The method of  claim 12 , wherein the capsule comprises gelatin. 
     
     
         14 . The method of  claim 13 , wherein 1 to 4 of the capsules are administered to the subject each day. 
     
     
         15 . The method of  claim 1 , wherein the subject has atherosclerosis.