US2021145787A1PendingUtilityA1

Methods of reducing apolipoprotein c-iii

Assignee: AMARIN PHARMACEUTICALS IE LTDPriority: Feb 6, 2013Filed: Nov 23, 2020Published: May 20, 2021
Est. expiryFeb 6, 2033(~6.5 yrs left)· nominal 20-yr term from priority
A61P 43/00A61K 31/23A61P 3/06A61K 31/232A61P 3/00
75
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Claims

Abstract

In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.

Claims

exact text as granted — not AI-modified
1 . A method of reducing an apolipoprotein C3 (APOC3) level of a subject on statin therapy and having baseline total APOC3 levels of about 12 mg/dL to about 18 mg/dL, the method comprising administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of ethyl eicosapentaenoate per day. 
     
     
         2 . The method of  claim 1 , wherein the APOC3 level is reduced by at least about 5%. 
     
     
         3 . The method of  claim 1 , wherein the APOC3 level is reduced by at least about 15%. 
     
     
         4 . The method of  claim 1 , wherein about 2 g per day of ethyl eicosapentaenoate is administered to the subject. 
     
     
         5 . The method of  claim 1 , wherein about 3.8 g to about 4 g per day of ethyl eicosapentaenoate is administered to the subject. 
     
     
         6 . The method of  claim 1 , wherein the pharmaceutical composition is administered to the subject daily for a period of 1 to about 12 weeks. 
     
     
         7 . The method of  claim 1 , wherein the reduction in APOC3 level is in comparison to control subjects having baseline total APOC3 levels of about 12 mg/dL to about 18 mg/dL who have received the statin but not the pharmaceutical composition. 
     
     
         8 . The method of  claim 1 , wherein the pharmaceutical composition comprises at least about 95%, by weight of all fatty acids present, ethyl eicosapentaenoate. 
     
     
         9 . The method of  claim 1 , wherein the pharmaceutical composition comprises no more than about 10%, by weight of all fatty acids present, docosahexaenoic acid or a derivative thereof, if any. 
     
     
         10 . The method of  claim 1 , wherein the subject has fasting baseline triglycerides of about 200 mg/dl to about 499 mg/dl. 
     
     
         11 . A method of reducing an apolipoprotein C3 (APOC3) level of a subject having baseline total APOC3 levels of about 18 mg/dL to about 36 mg/dL, the method comprising administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of ethyl eicosapentaenoate per day. 
     
     
         12 . The method of  claim 11 , wherein the APOC3 level is reduced by at least about 5%. 
     
     
         13 . The method of  claim 11 , wherein the APOC3 level is reduced by at least about 25%. 
     
     
         14 . The method of  claim 11 , wherein about 2 g per day of ethyl eicosapentaenoate is administered to the subject. 
     
     
         15 . The method of  claim 11 , wherein about 3.8 g to about 4 g per day of ethyl eicosapentaenoate is administered to the subject. 
     
     
         16 . The method of  claim 11 , wherein the pharmaceutical composition is administered to the subject daily for a period of 1 to about 12 weeks. 
     
     
         17 . The method of  claim 11 , wherein the reduction in APOC3 level is in comparison to control subjects having baseline total APOC3 levels of about 18 mg/dL to about 36 mg/dL who have not received the pharmaceutical composition. 
     
     
         18 . The method of  claim 11 , wherein the pharmaceutical composition comprises at least about 95%, by weight of all fatty acids present, ethyl eicosapentaenoate. 
     
     
         19 . The method of  claim 11 , wherein the pharmaceutical composition comprises no more than about 10%, by weight of all fatty acids present, docosahexaenoic acid or a derivative thereof, if any. 
     
     
         20 . The method of  claim 11 , wherein the subject has fasting baseline triglycerides of at least about 500 mg/dl.

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