Compositions and methods for lowering triglycerides without raising LDL-C levels 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 reducing triglycerides in a subject having a fasting baseline triglyceride level of at least about 700 mg/dl, a body mass index (BMI) of at least about 31 kg/m 2 , and on a statin therapy, the method comprising administering to the subject about 4 g of ethyl eicosapentaenoate per day.
2. The method of claim 1 , wherein the ethyl eicosapentaenoate is present in a pharmaceutical composition and the ethyl eicosapentaenoate comprises at least about 96 wt. % of all omega-3 fatty acids in the pharmaceutical composition.
3. The method of claim 2 , wherein about 1 g of the pharmaceutical composition is present in each of 4 capsules.
4. The method of claim 1 , wherein the subject has a baseline LDL-C level of about 40 mg/dL to about 100 mg/dL.
5. The method of claim 1 , wherein the subject is diabetic.
6. The method of claim 1 , wherein the subject exhibits at least about a 10% reduction in fasting triglycerides compared to a baseline triglyceride level.
7. The method of claim 6 , wherein the subject exhibits no statistically significant increase in LDL-C compared to an LDL-C level prior to initial administration of the ethyl eicosapentaenoate.
8. The method of claim 1 , wherein the statin therapy is a stable statin therapy.
9. The method of claim 1 , wherein the subject is administered the ethyl eicosapentaenoate for at least about 12 weeks.
10. The method of claim 1 , further comprising reducing a risk of stroke, myocardial infarction, or both in the subject.
11. A method of reducing triglycerides in a subject having a fasting baseline triglyceride level of at least about 500 mg/dl, a body mass index (BMI) of at least about 31 kg/m 2 , and on a statin therapy, the method comprising administering to the subject about 4 g of ethyl eicosapentaenoate per day.
12. The method of claim 11 , wherein the ethyl eicosapentaenoate is present in a pharmaceutical composition and the ethyl eicosapentaenoate comprises at least about 96 wt. % of all omega-3 fatty acids in the pharmaceutical composition.
13. The method of claim 12 , wherein about 1 g of the pharmaceutical composition is present in each of 4 capsules.
14. The method of claim 11 , wherein the subject has a baseline LDL-C level of about 40 mg/dL to about 100 mg/dL.
15. The method of claim 11 , wherein the subject is diabetic.
16. The method of claim 11 , wherein the subject exhibits at least about a 10% reduction in fasting triglycerides compared to a baseline triglyceride level.
17. The method of claim 16 , wherein the subject exhibits no statistically significant increase in LDL-C compared to an LDL-C level prior to initial administration of the ethyl eicosapentaenoate.
18. The method of claim 11 , wherein the statin therapy is a stable statin therapy.
19. The method of claim 11 , wherein the subject is administered the ethyl eicosapentaenoate for at least about 12 weeks.
20. The method of claim 11 , further comprising reducing a risk of stroke, myocardial infarction, or both in the subject.