Omega-3 pentaenoic acid compositions and methods of use

Abstract

Orally administrable composition comprising fatty acids comprising omega-3-fatty adds, salts or derivatives thereof are provided. These compositions can be used for the treatment or prophylaxis of dyslipidemic, cardiovascular, CNS, inflammatory, and other diseases/conditions or risk factors therefore.

What is claimed: 
     
         1 . A method of treating, preventing, reducing the occurrence of, and improving symptoms associated with a liver-related disease or condition in a subject in need thereof, comprising administering to the subject a composition comprising fatty acids, wherein at least 50% by weight of the fatty acids comprise omega-3 fatty acids, salts, esters, or derivatives thereof, wherein the omega-3 fatty acids comprise eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA) and wherein the ratio of docosahexaenoic acid to DHA to EPA (DHA:EPA) is less than 1:10, and wherein the ratio of DHA to DPA (DHA:DPA) is less than 2:1. 
     
     
         2 . The method of  claim 1 , wherein the liver-related disease or condition is selected from the group consisting of: fatty liver, non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), alcoholic steatohepatitis (ASH), hepatitis, HIV (human immunodeficiency virus) infection, drug-induced fatty liver or sequelae, liver failure, liver transplantation, transplanted liver failure, liver damage associated with renal failure or disease, abnormally elevated liver enzymes, or type 2 diabetes. 
     
     
         3 . The method of  claim 1 , wherein the ratio of DHA:EPA is less than 1:20. 
     
     
         4 . The method of  claim 1 , wherein the ratio of DHA:DPA is less than 1:1. 
     
     
         5 . The method of  claim 1 , wherein the ratio of EPA to DPA (EPA:DPA) is between 30:1 and 1:1. 
     
     
         6 . The method of  claim 1 , wherein ratio of DHA:EPA is less than 1:10. 
     
     
         7 . The method of  claim 1 , wherein the composition comprises DHA in an amount less than 5% of the total amount of fatty acids. 
     
     
         8 . The method of  claim 1 , wherein the composition comprises EPA in an amount between about 80% and about 90% of the total amount of fatty acids. 
     
     
         9 . The method of  claim 1 , wherein the composition comprises DPA in an amount between about 5% and about 15% of the total amount of fatty acids. 
     
     
         10 . The method of  claim 1 , wherein the composition comprises DPA free fatty acid or a salt, ester or derivative of DPA. 
     
     
         11 . The method of  claim 1 , wherein composition comprises EPA free fatty acid or a salt, ester or derivative of EPA. 
     
     
         12 . A method of treating, preventing, reducing the occurrence of, and improving symptoms associated with a liver-related disease or condition in a subject in need thereof, comprising administering to the subject a composition comprising eicosapentaenoic acid (EPA) in an amount between about 750 mg/g to about 950 mg/g,
 and wherein the composition comprises no more than 5% DHA of the total amount of fatty acids, and   and wherein the ratio of DHA:DPA is 1:1 or lower.   
     
     
         13 . The method of  claim 12 , wherein the liver-related disease or condition is selected from the group consisting of; fatty liver, non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), alcoholic steatohepatitis (ASH), hepatitis, HIV (human immunodeficiency virus) infection, drug-induced fatty liver or sequelae, liver failure, liver transplantation, transplanted liver failure, liver damage associated with renal failure or disease, abnormally elevated liver enzymes, or type 2 diabetes. 
     
     
         14 . The method of  claim 12 , wherein the composition comprises eicosapentaenoic acid (EPA) in an amount between about 800 mg/g to about 900 mg/g,
 and wherein the composition comprises no more than 5% DHA of the total amount of fatty acids, and   and wherein the ratio of DHA:DPA is 1:1 or lower.   
     
     
         15 . The method of  claim 12 , wherein the composition comprises eicosapentaenoic acid (EPA) in an amount between about 830 mg/g to about 870 mg/g,
 and wherein the composition comprises no more than 5% DHA of the total amount of fatty acids, and   and wherein the ratio of DHA:DPA is 1:1 or lower.   
     
     
         16 . The method of  claim 12 , wherein the composition comprises docosapentaenoic acid (DPA) is an amount between about 60 mg/g to about 120 mg/g. 
     
     
         17 . The method of  claim 1 , wherein the composition comprises docosapentaenoic acid (DPA) is an amount between about 70 mg/g to about 100 mg/g. 
     
     
         18 . A method of treating, preventing, reducing the occurrence of, and improving symptoms associated with a liver-related disease or condition in a subject in need thereof, comprising administering to the subject a composition comprising:
 eicosapentaenoic acid (EPA) in an amount between about 70% to about 95% of the total amount of fatty acids and   docosapentaenoic acid (DPA),   wherein the composition comprises no more than 5% docosahexaenoic acid (DHA) of the total amount of fatty acids, and   wherein the ratio of DHA:DPA is 1:1 or lower.   
     
     
         19 . The method of  claim 18 , wherein the liver-related disease or condition is selected from the group consisting of: fatty liver, non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), alcoholic steatohepatitis (ASH), hepatitis, HIV (human immunodeficiency virus) infection, drug-induced fatty liver or sequelae, liver failure, liver transplantation, transplanted liver failure, liver damage associated with renal failure or disease, abnormally elevated liver enzymes, or type 2 diabetes. 
     
     
         20 . The method of  claim 18 , wherein the composition comprises eicosapentaenoic acid (EPA) in an amount between about 80% to about 90% of the total amount of fatty acids. 
     
     
         21 . The method of  18 , wherein the composition comprises eicosapentaenoic acid (EPA) in an amount between about 82% to about 88% of the total amount of fatty acids. 
     
     
         22 . The method of  18 , wherein the composition comprises docosapentaenoic acid (DPA) in amount between about 5% and about 15% of the total amount of fatty acids. 
     
     
         23 . The method of  18 , wherein the composition comprises docosapentaenoic acid (DPA) in an amount between about 6% to about 12% of the total amount of fatty acids. 
     
     
         24 . The method of  claim 18 , wherein the composition comprises EPA free fatty acid or a salt, ester or derivative of EPA. 
     
     
         25 . A method of treating, preventing, reducing the occurrence of, and improving symptoms associated with a liver-related disease or condition in a subject in need thereof, comprising administering to the subject a composition comprising eicosapentaenoic acid (EPA) in a daily dosage amount of between about 1000 mg to about 5000 mg,
 and further comprising docosapentaenoic acid (DPA) and docosahexaenoic acid (DHA),   wherein the composition comprises no more than 5% DHA of the total amount of fatty acids, and wherein the ratio of DHA:DPA is 1:1 or lower.   
     
     
         26 . The method of  claim 25 , wherein the liver-related disease or condition is selected from the group consisting of: fatty liver, non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), alcoholic steatohepatitis (ASH), hepatitis, HIV (human immunodeficiency virus) infection, drug-induced fatty liver or sequelae, liver failure, liver transplantation, transplanted liver failure, liver damage associated with renal failure or disease, abnormally elevated liver enzymes, or type 2 diabetes. 
     
     
         27 . The method of  claim 25 , wherein the composition comprises eicosapentaenoic acid (EPA) in a daily dosage amount selected from the group consisting of: about 1735 mg to about 1855 mg, about 2520 mg to about 2780 mg, and about 3360 mg to about 3710 mg. 
     
     
         28 . The method of  claim 25 , wherein the composition comprises eicosapentaenoic acid (EPA) in a daily dosage amount selected from the group consisting of: about 1750 mg to about 1950 mg, about 1800 mg to about 2000 mg about 2650 mg to about 2950 mg, and about 3500 mg to about 3900 mg. 
     
     
         29 . The method of  claim 25 , wherein the composition comprises eicosapentaenoic acid (EPA) in daily dosage amount selected from the group consisting of: about 1900 mg to about 2100 mg, about 2700 mg to about 3300 mg, and about 3700 mg to about 4300 mg. 
     
     
         30 . The method of  claim 25 , wherein the composition comprises EPA free fatty acid or a salt, ester or derivative of EPA. 
     
     
         31 . The method of  claim 25 , wherein the composition comprises DPA free fatty acid or a salt, ester or derivative of DPA. 
     
     
         32 . A method of treating, preventing, reducing the occurrence of, and improving symptoms associated with a liver-related disease or condition in a subject in need thereof, comprising administering to the subject a composition comprising eicosapentaenoic acid (EPA) and docosapentaenoic add (DPA), wherein the amount of EPA and DPA is about 55% or more by weight of the total amount of fatty acids, and wherein the ratio of DHA:DPA is no more than 1:1. 
     
     
         33 . The method of  claim 32 , wherein the liver-related disease or condition is selected from the group consisting of; fatty liver, non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), alcoholic steatohepatitis (ASH), hepatitis, HIV (human immunodeficiency virus) infection, drug-induced fatty liver or sequelae, liver failure, liver transplantation, transplanted liver failure, liver damage associated with renal failure or disease, abnormally elevated liver enzymes, or type 2 diabetes. 
     
     
         34 . The method of  claim 32 , wherein the composition comprises a daily dosage of about 120 mg/day to about 150 mg/day. 
     
     
         35 . The method of  claim 32 , wherein the composition comprises a daily dosage of DPA of about 150 mg/day to about 200 mg/day. 
     
     
         36 . The method of  claim 32 , wherein the composition comprises a daily dosage of DPA of about 200 mg/day to about 250 mg/day. 
     
     
         37 . The method of  claim 32 , wherein the composition comprises a daily dosage of DPA of about 250 mg/day to about 300 mg/day. 
     
     
         38 . The method of  claim 32 , wherein the composition comprises a daily dosage of DPA of about 300 mg/day to about 400 mg/day. 
     
     
         39 . The method of  claim 32 , wherein the composition comprises a daily dosage of DPA of about 400 mg/day to about 600 mg/day. 
     
     
         40 . The method of  claim 32 , wherein the composition comprises a daily dosage of DPA of about 600 mg/day to about 1000 mg/day. 
     
     
         41 . The method of  claim 32 , wherein the composition further comprises eicosapentaenoic acid (EPA) and, wherein the amount of EPA and DPA is about 55% or more by weight of the total amount of fatty acids, and wherein the ratio of DHA:DPA is no more than 1:1. 
     
     
         42 . The method of  claim 32 , wherein the amount of EPA and DPA is selected from the group consisting of about 60% or more, about 65% or more, about 70% or more, about 75% or more, about 80% or more, about 85% or more, and about 90% or more by weight of the total amount of fatty acids. 
     
     
         43 . The method of  claim 32 , wherein the composition comprises further omega-6 fatty acids in an amount of no more than 6% of total amount of fatty acids. 
     
     
         44 . The method of  claim 32 , wherein the composition comprises no more than about 30% docosahexaenoic acid (DHA) by weight of fatty acids present in the composition. 
     
     
         45 . The method of  claim 32 , wherein the composition comprises no more than about 10% docosahexaenoic acid (DHA) by weight of fatty acids present in the composition. 
     
     
         46 . The method of  claim 32 , wherein the composition comprises no more than about 5% docosahexaenoic acid (DHA) by weight of fatty acids present in the composition. 
     
     
         47 . The method of  claim 32 , wherein the composition comprises DPA in ethyl ester form. 
     
     
         48 . The method of  claim 32 , wherein the composition comprises DPA in free fatty acid form. 
     
     
         49 . The method of  claim 32 , wherein the composition further comprises docosahexaenoic acid (DHA), and the ratio of DHA:DPA is no more than 2:1. 
     
     
         50 . The method of  claim 32 , wherein the composition further comprises docosahexaenoic acid (DHA), and the ratio of DHA:DPA is no more than 1:1. 
     
     
         51 . The method of  claim 32 , wherein the composition further comprises docosahexaenoic acid (DHA), and the ratio of DHA:DPA is no more than 1:2. 
     
     
         52 . The method of  claim 32 , wherein the composition further comprises docosahexaenoic acid (DHA), and the ratio of DHA:DPA is no more than 1:4. 
     
     
         53 . The method of  claim 32 , wherein the composition comprises at least about 6% docosapentaenoic acid (DPA) by weight of fatty acids present in the composition. 
     
     
         54 . The method of  claim 32 , wherein the composition comprises at least about 20% docosapentaenoic acid (DPA) by weight of fatty acids present in the composition. 
     
     
         55 . The method of  claim 32 , wherein the composition comprises at least about 50% docosapentaenoic acid (DPA) by weight of fatty acids present in the composition. 
     
     
         56 . A method of treating, preventing, reducing the occurrence of, and improving symptoms associated with a liver-related disease or condition in a subject in need thereof, comprising administering to the subject a composition comprising comprising: docosapentaenoic acid (DPA) in an amount between about 50% to about 80% of the total amount of fatty acids, docosahexaenoic acid (DHA) in an amount between about 25% to about 40% of the total amount of fatty acids, and optionally eicosapentaenoic acid (EPA) in an amount less than about 10% of the total amount of fatty acids. 
     
     
         57 . The method of  claim 56 , wherein the liver-related disease or condition is selected from the group consisting of: fatty liver, non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), alcoholic steatohepatitis (ASH), hepatitis, HIV (human immunodeficiency virus) infection, drug-induced fatty liver or sequelae, liver failure, liver transplantation, transplanted liver failure, liver damage associated with renal failure or disease, abnormally elevated liver enzymes, or type 2 diabetes. 
     
     
         58 . The method of  claim 56 , wherein the composition comprises docosapentaenoic acid (DPA) in an amount between about 50% to 75% of the total amount of fatty acids. 
     
     
         59 . The method of  claim 56 , wherein the composition comprises docosapentaenoic acid (DPA) in an amount between about 50% to 65% of the total amount of fatty acids. 
     
     
         60 . The method of  claim 56 , wherein the composition comprises docosahexaenoic acid (DHA) in an amount between about 25% to about 35%, of the total amount of fatty acids. 
     
     
         61 . The method of  claim 56 , wherein the composition comprises docosahexaenoic acid (DHA) in an amount between about 30% to about 35% of the total amount of fatty acids. 
     
     
         62 . The method of  claim 56 , wherein the composition comprises eicosapentaenoic acid (EPA) in an amount less than about 8% of the total amount of fatty acids. 
     
     
         63 . The method of  claim 56 , wherein the composition comprises eicosapentaenoic acid (EPA) in an amount less than about 5% of the total amount of fatty acids.