US2015190361A1PendingUtilityA1

Compositions and methods for lowering triglycerides in a subject on concomitant statin therapy

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Assignee: AMARIN PHARMACEUTICALS IE LTDPriority: Jun 15, 2009Filed: Mar 12, 2015Published: Jul 9, 2015
Est. expiryJun 15, 2029(~2.9 yrs left)· nominal 20-yr term from priority
Inventors:Ian OsterlohPierre WickerRene BraeckmanParesh SoniMehar Manku
A61P 9/10A61P 9/04A61P 9/06A61P 7/00A61P 9/00A61P 9/12A61P 3/06A61P 3/10A61P 3/00A61K 31/505A61K 31/366A61K 31/202A61K 31/232A61K 31/675C12P 7/64A61K 31/40A61K 31/215A61K 31/472A61K 9/48C07C 57/03
63
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Claims

Abstract

In various embodiments, the present invention provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject in need thereof.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of treating or preventing a cardiovascular-related disease in a subject who has been receiving non-statin lipid-altering therapy, the method comprising discontinuing the non-statin lipid-altering therapy and administering to the subject a composition comprising about 4 g of ethyl eicosapentaenoate per day. 
     
     
         2 . The method of  claim 1 , wherein the subject is further administered a statin. 
     
     
         3 . The method of  claim 2 , wherein the subject received a statin with the non-statin lipid-altering therapy. 
     
     
         4 . The method of  claim 1 , wherein after administration of the ethyl eicosapentaenoate the subject experiences no increase in a triglyceride level compared to a baseline triglyceride level associated with the subject while receiving the non-statin lipid-altering therapy. 
     
     
         5 . The method of  claim 4 , wherein after administration of the ethyl eicosapentaenoate the subject experiences a reduction in the triglyceride level compared to the baseline triglyceride level. 
     
     
         6 . The method of  claim 1 , wherein after administration of the ethyl eicosapentaenoate the subject experiences a reduction in an LDL-C level compared to a baseline LDL-C level in the subject measured while the subject is receiving the non-statin lipid-altering therapy. 
     
     
         7 . The method of  claim 1 , wherein after administration of the ethyl eicosapentaenoate the subject experiences no increase in a triglyceride level and a reduction in an LDL-C level compared to a baseline triglyceride level and a baseline LDL-C level in the subject measured while the subject is receiving the non-statin lipid-altering therapy. 
     
     
         8 . The method of  claim 1 , wherein after administration of the ethyl eicosapentaenoate the subject experiences a reduction in a total cholesterol level compared to a baseline total cholesterol level in the subject measured while the subject is receiving the non-statin lipid-altering therapy. 
     
     
         9 . The method of  claim 1 , wherein after administration of the ethyl eicosapentaenoate the subject experiences a reduction in a non-HDL-C level compared to a baseline non-HDL-C level in the subject measured while the subject is receiving the non-statin lipid-altering therapy. 
     
     
         10 . The method of  claim 1 , wherein after administration of the ethyl eicosapentaenoate the subject experiences no reduction or an increase in an HDL-C level compared to a baseline HDL-C level in the subject measured while the subject is receiving the non-statin lipid-altering therapy. 
     
     
         11 . The method of  claim 1 , wherein the ethyl eicosapentaenoate represents at least about 96%, by weight, of all fatty acids administered to the subject. 
     
     
         12 . The method of  claim 1 , wherein the subject is administered a composition comprising the ethyl eicosapentaenoate and not more than about 2%, by weight of total fatty acids, docosahexaenoic acid or derivative thereof. 
     
     
         13 . The method of  claim 12 , wherein the composition comprises not more than about 1%, by weight of total fatty acids, docosahexaenoic acid or derivative thereof. 
     
     
         14 . The method of  claim 12 , wherein the composition comprises not more than about 0.5%, by weight of total fatty acids, docosahexaenoic acid or derivative thereof. 
     
     
         15 . The method of  claim 12 , wherein the composition contains substantially no docosahexaenoic acid or derivative thereof. 
     
     
         16 . The method of  claim 1 , wherein the non-statin lipid-altering therapy comprises fibrates. 
     
     
         17 . The method of  claim 1 , wherein the non-statin lipid-altering therapy comprises fish oil. 
     
     
         18 . The method of  claim 1 , wherein the non-statin lipid-altering therapy comprises an omega-3 fatty acid other than ethyl eicosapentaenoate. 
     
     
         19 . The method of  claim 1 , wherein the non-statin lipid-altering therapy comprises mixed omega-3 fatty acids. 
     
     
         20 . The method of  claim 1 , wherein the cardiovascular-related disease is diabetes. 
     
     
         21 . The method of  claim 1 , wherein the ethyl eicosapentaenoate is administered to the subject in 1 to about 4 capsules per day. 
     
     
         22 . A method of treating or preventing a cardiovascular-related disease in a subject receiving non-statin lipid-altering therapy, the method comprising discontinuing the non-statin lipid-altering therapy and administering to the subject a composition comprising at least about 96%, by weight of total fatty acids, ethyl eicosapentaenoate. 
     
     
         23 . The method of  claim 22 , wherein the subject is receiving concomitant statin therapy. 
     
     
         24 . The method of  claim 22 , wherein the non-statin lipid-altering therapy comprises fibrates. 
     
     
         25 . The method of  claim 22 , wherein the non-statin lipid-altering therapy comprises fish oil. 
     
     
         26 . The method of  claim 22 , wherein the non-statin lipid-altering therapy comprises an omega-3 fatty acid other than ethyl eicosapentaenoate. 
     
     
         27 . The method of  claim 22 , wherein the non-statin lipid-altering therapy comprises mixed omega-3 fatty acids. 
     
     
         28 . The method of  claim 22 , wherein the composition is administered to the subject in 4 capsules per day, each capsule comprising about 1 g of the ethyl eicosapentaenoate. 
     
     
         29 . The method of  claim 22 , wherein the composition contains not more than about 1%, by weight of total fatty acids, of docosahexaenoic acid or derivative thereof. 
     
     
         30 . The method of  claim 22 , wherein the cardiovascular-related disease is diabetes.

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