Pharmaceutical composition comprising omega-3 fatty acid and 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) about 0.1 mg to about 500 mg of a hydroxy-derivative of a statin or pharmaceutically acceptable salt thereof selected from a hydroxy-derivative of atorvastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin, fluvastatin, simvastatin, lovastatin, cerivastatin and pharmaceutically acceptable salts thereof; and (b) an oil comprising at least one omega-3 fatty acid that is at least 95%, by weight, ethyl eicosapentaenoate or at least about 95%, by weight, ethyl docosahexaenoate of the oil, wherein about 0.5 g to about 2 g of the composition is present in a capsule shell.
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 ethyl eicosapentaenoate and ethyl docosahexaenoic acid.
4. The pharmaceutical composition of claim 1 wherein the hydroxy-derivative of a statin is selected from ortho or para hydroxy-atorvastatin and pharmaceutically acceptable salts thereof.
5. The pharmaceutical composition of claim 4 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.
6. The pharmaceutical composition of claim 1 further comprising tocopherol in an amount of about 0.1% to about 0.3%, by weight.