US2022241234A1PendingUtilityA1

Methods of treating mixed dyslipidemia

Assignee: AMARIN PHARMACEUTICALS IE LTDPriority: Apr 29, 2009Filed: Apr 20, 2022Published: Aug 4, 2022
Est. expiryApr 29, 2029(~2.7 yrs left)· nominal 20-yr term from priority
A61K 31/40A61K 31/397A61K 9/20A61K 47/26A61P 3/08A61K 9/127A61K 45/06A61K 31/232A61K 31/74A61K 31/202A61P 3/04A61K 9/48A61P 3/00A61K 47/22A61P 3/10A61K 31/47A61K 31/366A61K 47/34A61P 9/00A61P 9/04A61K 31/222A61P 7/12A61P 1/16A61K 2121/00A61P 9/10A61P 31/18A61K 31/405A61P 25/28A61K 31/22A61P 3/06A61K 9/4858A61K 31/155A61K 31/337A61P 9/12A61P 7/02A61K 31/505A61P 9/06
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Claims

Abstract

The present disclosure relates to, inter alia, methods of treating mixed dyslipidemia with ethyl eicosapentaenoate.

Claims

exact text as granted — not AI-modified
I/We claim: 
     
         1 . A method of treating or preventing a cardiovascular disease in a subject in need thereof, the method comprising administering eicosapentaenoic acid (EPA) and a statin to the subject, wherein the EPA and the statin are present in a capsule, the EPA is present in an amount of at least about 95%, by weight, of all fatty acids, and the EPA is administered to the subject in an amount sufficient to provide a dose of about 2,500 mg to about 10,000 mg of the EPA per day. 
     
     
         2 . The method of  claim 1 , wherein the EPA is ethyl-EPA. 
     
     
         3 . The method of  claim 1 , wherein the EPA is administered to the subject in an amount sufficient to provide a dose of about 4,000 mg of the EPA per day. 
     
     
         4 . The method of  claim 1 , wherein the statin is at least one selected from the group consisting of lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin, fluvastatin, atorvastatin, and simvastatin. 
     
     
         5 . The method of  claim 1 , wherein the statin is atorvastatin. 
     
     
         6 . The method of  claim 1 , wherein the cardiovascular disease is myocardial infarction, stroke, or both. 
     
     
         7 . The method of  claim 1 , wherein the subject has a baseline LDL-C level of at least 100 mg/dl, a baseline non-HDL-C level of at least 130 mg/dl, and/or a baseline triglyceride level of at least 250 mg/dl. 
     
     
         8 . The method of  claim 1 , wherein the statin and the EPA are administered for a period of time to reduce an Apo-B level and a baseline non-HDL-C level in the subject. 
     
     
         9 . The method of  claim 1 , wherein the statin and the EPA are administered for a period of time to reduce an Apo-B level in the subject without increasing the baseline LDL-C level in the subject. 
     
     
         10 . The method of  claim 7 , comprising administering the statin and the EPA for a period of time to reduce an Apo-B level in the subject compared to a control subject who has a baseline triglyceride level of at least about 250 mg/dl and has received the statin but not the EPA. 
     
     
         11 . The method of  claim 1 , wherein the statin and the EPA are administered to the subject for a period of time of at least about 2 years. 
     
     
         12 . The method of  claim 3 , wherein the capsule is substantially free of docosahexaenoic acid (DHA). 
     
     
         13 . The method of  claim 12 , wherein the EPA is present in four 1 g capsules. 
     
     
         14 . The method of  claim 12 , wherein the statin is rosuvastatin and 5 mg of the rosuvastatin is present in at least one of the four capsules. 
     
     
         15 . The method of  claim 12 , wherein the statin is rosuvastatin and 10 mg of the rosuvastatin is present in at least one of the four capsules. 
     
     
         16 . The method of  claim 12 , wherein the statin is rosuvastatin and 20 mg of the rosuvastatin is present in at least one of the four capsules. 
     
     
         17 . The method of  claim 12 , wherein the statin is rosuvastatin and 40 mg of the rosuvastatin is present in at least one of the four capsules.

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