Compositions comprising eicosapentaenoic acid and mipomersen and methods of use thereof
The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.
1. A composition comprising mipomersen and least about 80%, by weight, of all fatty acids present, eicosapentaenoic acid and/or derivative thereof.
2. The composition of claim 1 , wherein the mipomersen is present in an amount less than, about equal to, or greater than an effective amount of mipomersen when administered as a monotherapy.
3. The composition of claim 1 , wherein the mipomersen comprises mipomersen nonadecasodium.
4. The composition of claim 1 , wherein the mipomersen is suspended in the eicosapentaenoic acid and/or derivative thereof.
5. The composition of claim 1 , wherein the mipomersen is in the form of an injectable solution.
6. The composition of claim 1 , wherein the composition comprises no more than about 20%, by weight, of all fatty acids (and/or derivatives thereof) present, docosahexaenoic acid and/or derivative thereof.
7. The composition of claim 1 , wherein the mipomersen is present in an amount of about 5 mg to about 2000 mg.
8. The composition of claim 1 , wherein the eicosapentaenoic acid and/or derivative thereof is present in an amount of about 400 mg to about 5000 mg.
9. The composition of claim 1 , wherein the mipomersen is present in an amount of about 2 mg to about 10 mg and the eicosapentaenoic acid and/or derivative thereof is present in an amount of about 400 mg to about 5000 mg.
10. A method of treating cardiovascular disease in a subject, the method comprising administering to the subject a composition comprising mipomersen and a composition comprising at least about 80%, by weight, of all fatty acids present, eicosapentaenoic acid and/or derivative thereof.
11. The method of claim 10 , wherein the method further comprises identifying the subject as having homozygous familial hypercholesterolemia (HoFH) before administering the composition comprising at least about 80%, by weight, of all fatty acids (and/or derivatives thereof) present, eicosapentaenoic acid and/or derivative thereof.
12. The method of claim 10 , wherein the subject is on statin therapy.
13. The method of claim 10 , wherein the composition comprising mipomersen and the composition comprising eicosapentaenoic acid and/or derivative thereof are present in a single dosage form.
14. The method of claim 10 , wherein the mipomersen is in a dosage form separate from the eicosapentaenoic acid and/or derivative thereof.
15. A method of reducing triglycerides in a hypertriglyceridemic subject on mipomersen therapy, the method comprising administering to the subject a composition comprising at least about 80%, by weight, of all fatty acids present, eicosapentaenoic acid and/or derivative thereof.
16. The method of claim 15 , wherein the eicosapentaenoic acid and/or derivative thereof and the mipomersen are present in a single dosage form.
17. The method of claim 15 , wherein the mipomersen is in a dosage form separate from the eicosapentaenoic acid and/or derivative thereof.
18. The method of claim 15 , wherein a cholesterol level is reduced in the subject compared to a second subject who has received the mipomersen but not the eicosapentaenoic acid and/or derivative thereof.
19. The method of claim 18 , wherein the cholesterol level is selected from the group consisting of: HDL-C, LDL-C, non-HDL-C, VLDL-C, and combinations thereof.
20. The composition of claim 1 , wherein the eicosapentaenoic acid derivative thereof is ethyl eicosapentaenoate.
21. The method of claim 10 , wherein the eicosapentaenoic acid derivative thereof is ethyl eicosapentaenoate.
22. The method of claim 15 , wherein the eicosapentaenoic acid derivative thereof is ethyl eicosapentaenoate.