COMPOSITIONS AND METHODS FOR LOWERING TRIGLYCERIDES IN A SUBJECT ON CONCOMITANT STATIN THERAPY
In various embodiments, the present invention provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject in need thereof.
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.