Treatment for non-alcoholic fatty liver diseases

Abstract

The present invention relates to the use of mixtures of vitamin E and polyunsaturated fatty acids (PUFAs) as agents for the prevention, control and/or treatment of conditions associated with excessive fat accumulation in the liver which is not caused by alcohol abuse. This includes prevention, control and/or treatment of non-alcoholic steatosis in the liver—known as non-alcoholic fatty liver disease (NAFLD)—and/or non-alcoholic steatohepatitis (NASH) in a subject in need thereof. In particular, the present invention relates to the use of such compounds comprising vitamin E and PUFAs as active ingredients in the manufacture of medicaments for the prevention, control and/or treatment of conditions related to NAFLD.

1 . Combination of vitamin E and polyunsaturated fatty acid (PUFA) in the use of prevention, control or treatment of non-alcoholic fat accumulation in the liver in a subject in need thereof, preferably for prevention, control or treatment of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis, wherein the ratio of vitamin E and polyunsaturated fatty acids is administered in the range of about 1:1 to about 1:5, or in the range of about 4:1 to about 20:1, wherein the vitamin E is calculated as α-tocopherol and the ratio is calculated as weight ratio. 
     
     
         2 . Combination according to  claim 1 , wherein the vitamin E is selected from the group consisting of α-tocopherol, β-tocopherol, γ-tocopherol, δ-tocopherol and mixtures thereof, preferably α-tocopherol and/or γ-tocopherol. 
     
     
         3 . Combination according to  claim 1 , wherein the polyunsaturated fatty acid is selected from the group consisting of ω-3, ω-6, ω-9 polyunsaturated fatty acids and oxylipins derived therefrom, preferably ω-6 or ω-3 PUFAs, more preferably selected from ω-3 α-linolenic acid, ω-3 eicosapentaenoic acid, ω-3 docosapentaenoic acid, ω-3 docosahexaenoic, ω-3 docosatetraenoic acid, ω-6 γ linolenic acid, ω-6 linoleic acid, ω-6 conjugated linoleic acid, ω-6 arachidonic acid, ω-6 docosapentaenoic acid, and combinations thereof. 
     
     
         4 . Combination according to  claim 1 , wherein the ratio of vitamin E and polyunsaturated fatty acids is administered in the range of about 1:1 to about 1:5, or in the range of about 4:1 to about 20:1, wherein the vitamin E is calculated as α-tocopherol and the ratio is calculated as weight ratio. 
     
     
         5 . Combination according to  claim 1 , wherein the amount of vitamin E is from about 5 to about 2000 mg per day and the amount of PUFA is from about 10 mg to about 4000 mg per day. 
     
     
         6 . A composition substantially consisting of vitamin E and PUFA for prevention, control or treatment of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis, wherein a combination according to  claim 1  is used. 
     
     
         7 . A composition with hepatoprotective effect in the form of a tablet, soft drink or gelatin capsule comprising a combination according to  claim 1 . 
     
     
         8 . A process for the preparation of a tablet, soft drink or gelatin capsule having hepatoprotective effect, said process comprising the step of mixing a combination according to  claim 1  with one or more of the following ingredients selected from water, vegetable oils, gelatin, lubricants, and/or cellulose. 
     
     
         9 . A method for the treatment or prevention of diseases associated with non-alcoholic fat accumulation in the liver, which comprises administering to the subject in need thereof an effective amount of PUFA and vitamin E according to  claim 1 .