PHARMACEUTICAL COMPOSITION COMPRISING AN OMEGA-3 FATTY ACID AND A HYDROXY-DERIVATIVE OF A STATIN AND METHODS OF USING SAME
In various embodiments, the present invention provides compositions and methods for treating and/or preventing a cardiovascular-related disease in subject in need thereof.
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, wherein a molar ratio of the omega-3 fatty acid to the hydroxy-derivative of the statin is about 1:1 to about 20:1.
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 the group consisting of: 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 . The pharmaceutical composition of claim 1 , wherein the molar ratio of the omega-3 fatty acid to the hydroxy-derivative of the statin is about 10:1.
13 . The pharmaceutical composition of claim 3 , wherein the hydroxy-derivative of a statin is a hydroxy-atorvastatin or a pharmaceutically acceptable salt thereof.
14 . The pharmaceutical composition of claim 4 , wherein the hydroxy-derivative of a statin is a hydroxy-atorvastatin or a pharmaceutically acceptable salt thereof.
15 . A pharmaceutical composition comprising (a) rosuvastatin and (b) an oil comprising at least 95% by weight ethyl eicosapentaenoate, wherein a molar ratio of ethyl eicosapentaenoate to rosuvastatin is about 1:1 to about 20:1.
16 . The pharmaceutical composition of claim 15 , wherein the molar ratio is about 10:1.
17 . A pharmaceutical composition comprising (a) rosuvastatin and (b) an oil comprising at least 95% by weight ethyl docosahexaenoic acid, wherein a molar ratio of ethyl docosahexaenoic acid to rosuvastatin is about 1:1 to about 20:1.
18 . The pharmaceutical composition of claim 17 , wherein the molar ratio is about 10:1.
19 . The composition of claim 1 , wherein the hydroxy-derivative of a statin is ortho-hydroxy atorvastatin.
20 . A method of treating a cardiovascular-related disease in a subject in need thereof comprising administering to the subject the composition of claim 1 .
21 . The method of claim 20 , wherein the cardiovascular disease is selected from hypertriglyceridemia, hypercholesterolemia, mixed dyslipidemia, coronary heart disease, vascular disease, stroke, atherosclerosis, arrhythmia, hypertension, and myocardial infarction.
22 . The method of claim 20 , wherein the cardiovascular disease is atherosclerosis.
23 . A method of treating a cardiovascular-related disease in a subject in need thereof comprising administering to the subject the composition of claim 13 .
24 . A method of treating a cardiovascular-related disease in a subject in need thereof comprising administering to the subject the composition of claim 14 .
25 . A method of treating a cardiovascular-related disease in a subject in need thereof comprising administering to the subject the composition of claim 15 .
26 . A method of treating a cardiovascular-related disease in a subject in need thereof comprising administering to the subject the composition of claim 17 .