Low eructation composition and methods for treating and/or preventing cardiovascular disease in a subject with fish allergy/hypersensitivity

Abstract

In various embodiments, the present invention provides pharmaceutical compositions comprising fatty acids and methods for treating subjects using same.

1 . A method of treating or preventing cardiovascular-related diseases in a subject that is allergic to or hypersensitive to fish, the method comprising:
 identifying a subject that is allergic to or hypersensitive to fish and has or is at risk for developing a cardiovascular-related disease; and   administering to the subject an effective amount of a composition comprising eicosapentaenoic acid or a derivative thereof, wherein said composition contains substantially no proteins.   
     
     
         2 . The method of  claim 1  wherein the composition comprises at least about 96% by weight eicosapentaenoic acid or a derivative thereof. 
     
     
         3 . The method of  claim 1  wherein the eicosapentaenoic acid or a derivative thereof comprises E-EPA. 
     
     
         4 . The method of  claim 3  wherein the composition contains less than about 3% by weight, if any, of any fatty acid other than E-EPA. 
     
     
         5 . The method of  claim 1  wherein the composition further comprises tocopherol in an amount of about 0.1% to about 0.3%, by weight. 
     
     
         6 . The method of  claim 1  wherein the composition is administered in an amount sufficient to increase plasma and/or serum EPA levels in the subject by at least about 200% compared to a baseline plasma and/or serum EPA level. 
     
     
         7 . The method of  claim 1  wherein the subject has a fasting baseline triglyceride level of about 500 mg/dl to about 1500 mg/dl. 
     
     
         8 . The method of  claim 1  wherein the pharmaceutical composition is substantially free of fish proteins or fish allergens. 
     
     
         9 . The method of  claim 1  wherein the cardiovascular-related disease is one or more of: hypertriglyceridemia, primary hypercholesterolemia, mixed dyslipidemia, atherosclerotic disease, very high serum triglyceride levels, and arterial plaque development. 
     
     
         10 . A method of treating hypertriglyceridemia in a subject in need thereof, comprising: (a) identifying a subject having a fasting baseline triglyceride level of about 500 mg/dl to about 2000 mg/dl and that is allergic to fish or seafood, and (b) administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of a pharmaceutical composition comprising at least about 90%, by weight, ethyl eicosapentaenoate, wherein the composition contains substantially no DHA or derivative thereof and wherein upon administration the subject does not experience skin rash or experiences reduced incidence of skin rash compared to placebo or to an equivalent milligram dose of a commercially available prescription omega-3 fatty acid composition. 
     
     
         11 . The method of  claim 10  wherein the subject experiences no eructation, no increased eructation compared to placebo or reduced eructation compared to an equivalent milligram dose of a commercially available omega-3 fatty acid composition. 
     
     
         12 . The method of  claim 10  wherein the commercially available prescription omega-3 fatty acid composition is Lovaza. 
     
     
         13 . The method of  claim 10  wherein the subject is on concomitant statin therapy. 
     
     
         14 . A pharmaceutical composition comprising eicosapentaenoic acid, or a derivative thereof, wherein the pharmaceutical composition contains less than about 1%, by weight, of proteins, if any. 
     
     
         15 . The pharmaceutical composition of  claim 14  wherein the pharmaceutical composition contains substantially no protein. 
     
     
         16 . The pharmaceutical composition of  claim 14  wherein the pharmaceutical composition contains no protein. 
     
     
         17 . The pharmaceutical composition of  claim 14  wherein the pharmaceutical composition contains no fish allergen. 
     
     
         18 . The pharmaceutical composition of  claim 14  wherein the pharmaceutical composition contains at least about 96%, by weight, ethyl eicosapentaenoate. 
     
     
         19 . The pharmaceutical composition of  claim 14  wherein the pharmaceutical composition contains substantially no ethyl-DHA. 
     
     
         20 . The pharmaceutical composition of  claim 14  wherein the composition is encapsulated in a capsule. 
     
     
         21 . The method of  claim 1 , wherein the subject is on concomitant statin therapy. 
     
     
         22 . The method of  claim 1 , wherein the composition is encapsulated in a capsule. 
     
     
         23 . The method of  claim 10 , wherein the composition is encapsulated in a capsule.