US2012157530A1PendingUtilityA1

Methods of treating hypertriglyceridemia

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Assignee: MANKU MEHARPriority: Feb 10, 2009Filed: Feb 24, 2012Published: Jun 21, 2012
Est. expiryFeb 10, 2029(~2.6 yrs left)· nominal 20-yr term from priority
A61P 3/06A61K 31/202A61K 31/232A61K 45/06A61K 31/20A61K 31/397G16Z 99/00A61P 7/00
67
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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 fasting triglycerides in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 2000 mg/dl comprising administering to the subject about 2 g to about 4 g per day of a pharmaceutical composition comprising eicosapentaenoic acid and docosahexaenoic acid in free acid form for a period effective to reduce fasting triglycerides in the subject. 
     
     
         2 . The method of  claim 1  wherein the composition is administered to the subject 1 to 4 times per day. 
     
     
         3 . The method of  claim 2  wherein the composition is present in one or more capsules. 
     
     
         4 . The method of  claim 3  wherein each of said one or more capsules contains about 800 mg to about 1200 mg of eicosapentaenoic acid. 
     
     
         5 . The method of  claim 4  wherein each of said one or more capsules contains not more than about 10% by weight of any individual fatty acid selected from linolenic acid, alpha-linolenic acid, stearadonic acid, eicosatrienoic acid and docasapentaenoic acid. 
     
     
         6 . The method of  claim 5  wherein each of said one or more capsules contains about 2000 mg to about 2400 mg of eicosapentaenoic acid. 
     
     
         7 . The method of  claim 6  wherein each of said one or more capsules contains not more than about 10% by weight of any individual fatty acid selected from linolenic acid, alpha-linolenic acid, stearadonic acid, eicosatrienoic acid and docasapentaenoic acid. 
     
     
         8 . The method of  claim 1  wherein the period effective to reduce fasting triglycerides is about 1 week to about 15 weeks. 
     
     
         9 . The method of  claim 8  wherein the period effective to reduce fasting triglycerides is about 1 week to about 12 weeks. 
     
     
         10 . The method of  claim 9  wherein the period effective to reduce fasting triglycerides is about 1 week to about 5 weeks. 
     
     
         11 . The method of  claim 10  wherein the subject exhibits an increase in serum EPA and DHA after said period effective to reduce fasting triglycerides. 
     
     
         12 . The method of  claim 1  wherein the subject has a baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl. 
     
     
         13 . The method of  claim 12  wherein upon administering to the subject 2 g to about 4 g of said pharmaceutical composition daily for said period, the subject further exhibits (a) substantially no change or a reduction in fasting non-HDL-C compared to a fasting non-HDL-C level at a baseline prior to initial administration of the pharmaceutical composition; and (b) substantially no change or a reduction in fasting VLDL-C compared to a fasting VLDL-C level at a baseline prior to initial administration of the pharmaceutical composition. 
     
     
         14 . The method of  claim 13  wherein upon administering to the subject about 2 g to about 4 g of said pharmaceutical composition daily for said period the subject further exhibits: (a) a reduction in fasting triglycerides of at least about 25% compared to a fasting triglyceride level at a baseline prior to initial administration of the pharmaceutical composition; and (b) a reduction in fasting non-HDL-C of at least about 5% compared to a fasting non-HDL-C level at a baseline prior to initial administration of the pharmaceutical composition.

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