Statin and omega-3 fatty acids for reduction of apo-b levels

Abstract

Methods of utilizing a combined administration or a unit dosage of a combination of an HMG-CoA inhibitor and omega-3 fatty acids for the reduction of apolipoprotein-B levels. The methods are especially useful in the treatment of patients with hypertriglyceridemia or hypercholesterolemia or mixed dyslipidemia, coronary heart disease (CHD), vascular disease, atherosclerotic disease and related conditions, and for the prevention or reduction of cardiovascular, cardiac, and vascular events.

1 . A method of reducing Apo-B and non-HDL-cholesterol levels in a subject group, comprising
 providing a subject group with a baseline LDL-cholesterol level of at least 100 mg/dL, a baseline non-HDL-cholesterol level of at least 130 mg/dL, and a baseline triglyceride level of at least 200 mg/dL, and   reducing the Apo-B and the non-HDL-cholesterol levels of the subject group by administering to the subject group a combination of a statin and omega-3 fatty acids in an amount effective to reduce the Apo-B and the non-HDL-cholesterol levels of the subject group in a statistically significant amount as compared to treatment with the statin alone, wherein the omega-3 fatty acids are present in a concentration of at least 80% by weight as compared to the total fatty acid content of the composition.   
     
     
         2 . The method of  claim 1 , wherein the subject group has at least one of the following conditions or diseases: hypertriglyceridemia, hypercholesterolemia, mixed dyslipidemia, vascular disease, and atherosclerotic disease. 
     
     
         3 . (canceled) 
     
     
         4 . The method of  claim 1 , wherein the subject group has a baseline LDL-cholesterol level of at least 100 mg/dL and less than 130 mg/dL. 
     
     
         5 . The method of  claim 1 , wherein the subject group has an a baseline LDL-cholesterol level of at least 130 mg/dL. 
     
     
         6 . (canceled) 
     
     
         7 . (canceled) 
     
     
         8 . (canceled) 
     
     
         9 . The method of  claim 1 , wherein the statin is selected from the group consisting of pitavastatin, atorvastatin, rosuvastatin, fluvastatin, lovastatin, pravastatin and simvastatin. 
     
     
         10 . The method of  claim 1  wherein the statin is simvastatin. 
     
     
         11 . (canceled) 
     
     
         12 . (canceled) 
     
     
         13 . The method of  claim 1 , wherein the omega-3 fatty acids comprise at least 80% by weight of EPA and DHA as compared to the total fatty acid content of the composition. 
     
     
         14 . The method of  claim 1 , wherein the omega-3 fatty acids comprise about 40% to about 55% by weight of EPA as compared to the total fatty acid content of the composition. 
     
     
         15 . The method of  claim 1 , wherein the omega-3 fatty acids comprise about 30% to about 60% by weight of DHA as compared to the total fatty acid content of the composition. 
     
     
         16 . The method of  claim 1 , wherein omega-3 fatty acids comprise omega-3 polyunsaturated, long-chain fatty acids, esters of omega-3 fatty acids with glycerol, esters of omega-3 fatty acids and a primary, secondary or tertiary alcohol, or mixtures thereof. 
     
     
         17 . The method of  claim 1 , wherein the omega-3 fatty acids comprise EPA and DHA in a ratio of EPA:DHA from 2:1 to 1:2. 
     
     
         18 . The method of  claim 1 , wherein the omega-3 fatty acids and the statin are administered together in a unit dose form. 
     
     
         19 . The method of  claim 1 , wherein the subject group has a baseline triglyceride level of 200 to 499 mg/dl. 
     
     
         20 . The method of  claim 1 , wherein an increase of an LDL-C level is avoided. 
     
     
         21 . The method of  claim 1 , wherein the statin is rosuvastatin. 
     
     
         22 . The method of  claim 1 , wherein the statin is atorvastatin. 
     
     
         23 . A method of reducing Apo-B levels in a subject group, comprising
 measuring LDL-cholesterol, non-HDL-cholesterol, and triglyceride levels in subjects,   providing a subject group with a baseline LDL-cholesterol level of at least 100 mg/dL, a baseline non-HDL-cholesterol level of at least 130 mg/dL, and a baseline triglyceride level of at least 200 mg/dL, and   reducing the Apo-B levels of the subject group by administering to the subject group a combination of a statin and omega-3 fatty acids in an amount effective to reduce the Apo-B levels of the subject group in a statistically significant amount as compared to treatment with the statin alone, wherein an increase of the LDL-cholesterol level is avoided and the omega-3 fatty acids are present in a concentration of at least 80% by weight as compared to the total fatty acid content of the composition.   
     
     
         24 . A method of reducing Apo-B levels in a subject group, comprising
 providing a subject group with a baseline LDL-cholesterol level of at least 100 mg/dL, a baseline non-HDL-cholesterol level of at least 130 mg/dL, and a baseline triglyceride level of at least 200 mg/dL,   reducing the Apo-B levels of the subject group by administering to the subject group a combination of a statin and omega-3 fatty acids in an amount effective to reduce the Apo-B levels of the subject group in a statistically significant amount as compared to treatment with the statin alone, wherein the omega-3 fatty acids are present in a concentration of at least 80% by weight as compared to the total fatty acid content of the composition, and   determining the reduction in the Apo-B levels of the subject group.