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

A pharmaceutical composition comprising nicotinic acid in an amount of not more than about 800 mg and eicosapentaenoic acid ethyl ester, wherein the composition contains substantially no amount of docosahexaenoic acid or derivative thereof.

A pharmaceutical composition comprising nicotinic acid in an amount of not more than about 500 mg and about 100 mg to about 1000 mg of eicosapentaenoic acid ethyl ester, wherein the composition contains no docosahexaenoic acid, the nicotinic acid is suspended in the eicosapentaenoic acid ethyl ester, and the composition is present in a capsule.

A method of treating a cardiovascular-related disease or disorder in a subject in need thereof, comprising:

• co-administering to the subject a first pharmaceutical composition comprising nicotinic acid in an amount of not more than about 800 mg and a second pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof wherein said second pharmaceutical composition contains substantially no docosahexaenoic acid or derivative thereof.

A method of decreasing serum low-density lipoprotein-C and serum triglyceride levels and increasing serum high-density-lipoprotein-C levels in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising:

• (a) nicotinic acid in an amount of not more than 1000 mg and (b) an oil comprising at least about 95%, by weight, eicosapentaenoic acid ethyl ester;
• wherein the pharmaceutical composition contains no docosahexaenoic acid or derivative thereof.

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.

A method of reducing risk of cardiac arrest in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising (a) nicotinic acid in an amount of not more than 1000 mg and (b) an oil comprising at least about 95%, by weight, eicosapentaenoic, acid ethyl ester, wherein the composition contains no docosahexaenoic acid or derivative thereof.

A kit comprising a first pharmaceutical composition comprising nicotinic acid in an amount of not more than 1200 mg and a second pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof, wherein the second pharmaceutical composition contains not more than 10%, by weight, docosahexaenoic acid, if any.

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, (b) pre-treating the subject with a pharmaceutical composition comprising at least about 95% by weight EPA or derivative thereof and (c) subsequently administering niacin to the subject.

A method of treating or reducing severity of niacin-induced flushing in a subject comprising (a) providing 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 in an amount sufficient to prevent reduce severity of said flushing.