US2011071176A1PendingUtilityA1

Pharmaceutical composition comprising omega-3 fatty acid and hydroxy-derivative of a statin and methods of using same

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Assignee: AMARIN PHARMA INCPriority: Sep 23, 2009Filed: Sep 23, 2010Published: Mar 24, 2011
Est. expirySep 23, 2029(~3.2 yrs left)· nominal 20-yr term from priority
Inventors:Jonathan Rowe
A61P 3/06A61K 31/47A61K 31/44A61K 31/405A61P 9/00A61K 45/06A61P 9/10A61P 9/06A61K 31/215A61K 31/40A61K 31/366A61K 31/20A61K 9/4858A61K 31/505A61K 31/202A61K 47/12A61K 31/4025
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Claims

Abstract

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

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A pharmaceutical composition comprising (a) a hydroxy-derivative of a statin or pharmaceutically acceptable salt thereof and (b) an oil comprising an omega-3 fatty acid. 
     
     
         2 . The pharmaceutical composition of  claim 1  wherein the omega-3 fatty acid comprises ethyl eicosapentaenoate. 
     
     
         3 . The pharmaceutical composition of  claim 1  wherein the oil comprises at least 95% by weight ethyl eicosapentaenoate. 
     
     
         4 . The pharmaceutical composition of  claim 1  wherein the oil comprises at least 95% by weight ethyl docosahexaenoic acid. 
     
     
         5 . The pharmaceutical composition of  claim 3  wherein the oil comprises ethyl eicosapentaenoate and ethyl docosahexaenoic acid. 
     
     
         6 . The pharmaceutical composition of  claim 5  wherein the oil comprises ethyl eicosapentaenoate and ethyl docosahexaenoic acid in a mole ratio of about 1:1 to about 1.5:1. 
     
     
         7 . The pharmaceutical composition of  claim 1  wherein the hydroxy-derivative of a statin or pharmaceutically acceptable salt thereof is selected from a hydroxy-derivative of atorvastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin, fluvastatin, simvastatin, lovastatin, cerivastatin and pharmaceutically acceptable salts thereof. 
     
     
         8 . The pharmaceutical composition of  claim 7  wherein the hydroxy-derivative of a statin is selected from ortho or para hydroxy-atorvastatin and pharmaceutically acceptable salts thereof. 
     
     
         9 . The pharmaceutical composition of  claim 8  wherein the hydroxy-derivative of a statin or pharmaceutically acceptable salt thereof is selected from o-hydroxy atorvastatin, p-hydroxy atorvastatin, p-hydroxy atorvastatin calcium, p-hydroxy atorvastatin disodium, o-hydroxy atorvastatin calcium, o-hydroxy atorvastatin lactone, o-hydroxy atorvastatin-d5 calcium, o-hydroxy atorvastatin-d5 disodium, o-hydroxy atorvastatin-d5 lactone, 2-hydroxy atorvastatin bisodium, p-hydroxy atorvastatin lactone, p-hydroxy atorvastatin-d5 calcium, p-hydroxy atorvastatin-d5 lactone, and 4-hydroxy atorvastatin bisodium. 
     
     
         10 . The pharmaceutical composition of  claim 1  further comprising tocopherol in an amount of about 0.1% to about 0.3%, by weight. 
     
     
         11 . The pharmaceutical composition of  claim 1  wherein about 0.5 g to about 2 g of said composition is present in a capsule shell. 
     
     
         12 . A method of treating a cardiovascular-related disease in a subject in need thereof comprising administering to the subject a composition comprising (a) a hydroxy-derivative of a statin or pharmaceutically acceptable salt thereof and (b) an oil comprising an omega-3 fatty acid. 
     
     
         13 . The method of  claim 12  wherein the omega-3 fatty acid comprises ethyl eicosapentaenoate. 
     
     
         14 . The method of  claim 13  wherein the oil comprises at least 95% by weight ethyl eicosapentaenoate. 
     
     
         15 . The method of  claim 14  wherein the oil comprises ethyl eicosapentaenoate and ethyl docosahexaenoic acid in a mole ratio of about 1.1 to 1 to about 1.5 to 1. 
     
     
         16 . The method of  claim 14  wherein the oil comprises ethyl docosahexaenoic acid. 
     
     
         17 . The method of  claim 12  wherein the hydroxy-derivative of a statin or pharmaceutically acceptable salt thereof is selected from ortho or para hydroxy atorvastatin and pharmaceutically acceptable salts thereof. 
     
     
         18 . The method of  claim 12  wherein the hydroxy-derivative of a statin or pharmaceutically acceptable salt thereof is selected from o-hydroxy atorvastatin, p-hydroxy atorvastatin, p-hydroxy atorvastatin calcium, p-hydroxy atorvastatin disodium, o-hydroxy atorvastatin calcium, o-hydroxy atorvastatin lactone, o-hydroxy atorvastatin-d5 calcium, o-hydroxy atorvastatin-d5 disodium, o-hydroxy atorvastatin-d5 lactone, 2-hydroxy atorvastatin bisodium, p-hydroxy atorvastatin lactone, p-hydroxy atorvastatin-d5 calcium, p-hydroxy atorvastatin-d5 lactone, and 4-hydroxy atorvastatin bisodium. 
     
     
         19 . The method of  claim 12  wherein the cardiovascular disease is selected from hypertriglyceridemia, hypercholesterolemia, mixed dyslipidemia, coronary heart disease, vascular disease, stroke, atherosclerosis, arrhythmia, hypertension, and myocardial infarction. 
     
     
         20 . The method of  claim 12  wherein the cardiovascular disease is atherosclerosis.

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