Pharmaceutical composition comprising eicosapentaenoic acid and nicotinic acid and methods of using same

Abstract

The present invention relates to, inter alia, pharmaceutical compositions comprising eicosapentaenoic acid and/or derivatives thereof and nicotinic acid, to methods of manufacturing such compositions, and to therapeutic methods for treating carious diseases and disorders.

What is claimed is: 
     
         1 . A pharmaceutical composition comprising nicotinic acid in an amount of not more than about 1200 mg and eicosapentaenoic acid or a derivative thereof, wherein the composition contains not more than 10%, by weight, docosahexaenoic acid, if any. 
     
     
         2 . The composition of  claim 1  wherein the composition contains substantially no docosahexaenoic acid. 
     
     
         3 . The composition of  claim 1  wherein the eicosapentaenoic acid or derivative thereof is present in an amount of about 100 mg to about 5000 mg. 
     
     
         4 . The composition of  claim 1  wherein the eicosapentaenoic acid or derivative thereof is present in an amount of about 100 mg to about 1000 mg. 
     
     
         5 . The composition of  claim 1  wherein the eicosapentaenoic acid or derivative thereof comprises an eicosapentaenoic acid ethyl ester. 
     
     
         6 . The composition of  claim 1  wherein the nicotinic acid is suspended in the eicosapentaenoic acid or derivative thereof to form a suspension. 
     
     
         7 . The composition of  claim 6  wherein the suspension is present in a capsule. 
     
     
         8 . The composition of  claim 1  wherein the composition further comprises a statin. 
     
     
         9 . A method of treating or preventing a cardiovascular-related disease or disorder in subject in need thereof, comprising: administering to the subject a pharmaceutical composition according to  claim 1 . 
     
     
         10 . A pharmaceutical composition comprising nicotinic acid in an amount of about 1 mg to about 200 mg dispersed in about 100 mg to about 1000 mg of an oil comprising at least about 95%, by weight, eicosapentaenoic acid ethyl ester, wherein the composition contains no docosahexaenoic acid or derivative thereof and is enclosed in a capsule shell. 
     
     
         11 . A method of treating or preventing a cardiovascular-related disease or disorder in subject in need thereof, comprising: administering to the subject a pharmaceutical composition according to  claim 10 . 
     
     
         12 . A method of preventing or reducing incidence or severity of niacin-induced flushing in a subject, comprising (a) providing a subject that has not yet initiated niacin therapy or a subject on niacin therapy that experiences flushing and (b) treating the subject with a pharmaceutical composition comprising at least about 95% by weight EPA or derivative thereof. 
     
     
         13 . The method of  claim 12 , further comprising (c) subsequently administering niacin to the subject in (a) that had not yet initiated niacin therapy. 
     
     
         14 . The method of  claim 13  wherein the subject is pre-treated with the pharmaceutical composition in an amount sufficient to provide about 1 mg to about 5000 mg of EPA or derivative thereof per day for a period of about 1 to about 30 days. 
     
     
         15 . The method of  claim 13  wherein the subject is pre-treated with the pharmaceutical composition in an amount sufficient to provide about 1 mg to about 2000 mg of EPA or derivative thereof per day for a period of about 1 to about 10 days.