Compositions and Methods for Lowering Triglycerides in a Subject Having Reduced Kidney Function

Abstract

In various embodiments, the present invention provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject having reduced kidney function.

What is claimed is: 
     
         1 . A method of treating or preventing a cardiovascular-related disease in a subject having baseline fasting triglycerides of at least about 150 mg/dL, low density lipoprotein cholesterol (LDL-C) control, and reduced kidney function, the method comprising administering to the subject a composition comprising about 4 g of more than about 96% ethyl eicosapentaenoate (E-EPA) per day for about 12 weeks, wherein after administration of the composition, the subject experiences a reduction in triglycerides and cardiovascular risk factors without raising LDL-C compared to a placebo control. 
     
     
         2 . The method of  claim 1 , wherein the subject has baseline fasting triglycerides of about 200 mg/dL to about 500 mg/dL. 
     
     
         3 . The method of  claim 1 , wherein the subject has an estimated glomerular filtration rate (eGFR) of less than about 90 mL/min/1.73 m 2  for at least about 3 months. 
     
     
         4 . The method of  claim 3 , wherein the subject has an eGFR of less than about 60 mL/min/1.73 m 2  for at least about 3 months. 
     
     
         5 . The method of  claim 1 , wherein the subject has diabetes mellitus. 
     
     
         6 . The method of  claim 1 , wherein the subject has a high sensitivity C-reactive protein (hsCRP) level of at least about 2 mg/L. 
     
     
         7 . The method of  claim 1 , wherein the subject has chronic kidney disease. 
     
     
         8 . The method of  claim 1 , wherein the subject's LDL-C levels are maintained between about 40 mg/dL to about 115 mg/dL. 
     
     
         9 . The method of  claim 1 , wherein the subject has coronary heart disease or a coronary heart disease risk equivalent. 
     
     
         10 . The method of  claim 9 , wherein the subject has the coronary heart disease risk equivalent if the subject has greater than about a 20% risk of developing coronary heart disease over a period of about 10 years. 
     
     
         11 . The method of  claim 1 , wherein the subject exhibits a reduction in one or more parameters selected from the group consisting of non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), very low-density lipoprotein cholesterol (vLDL-C), lipoprotein associated phospholipase A 2  (Lp-PLA 2 ), apolipoprotein B (Apo B), apolipoprotein-C III (Apo C-III), high density lipoprotein cholesterol (HDL-C), remnant lipoprotein cholesterol (RLP-C), and very low density lipoprotein triglyceride (vLDL-TG). 
     
     
         12 . The method of  claim 1 , wherein the subject does not experience a statistically significant change in serum creatinine levels, eGFR, and/or albumin levels following administration of E-EPA. 
     
     
         13 . The method of  claim 1 , wherein the subject is on concomitant statin therapy. 
     
     
         14 . The method of  claim 1 , wherein the subject is on stable statin therapy. 
     
     
         15 . The method of  claim 1 , wherein the subject has at least one cardiovascular-related disease.