Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
View Patent ↗In various embodiments, the present invention provides methods of reducing the risk of a cardiovascular event in a subject on statin therapy and, in particular, a method of reducing the risk of a cardiovascular event in a subject on statin therapy having a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL, and administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof.
1. A method of reducing a risk of coronary revascularization and/or unstable angina in a subject on statin therapy, the method comprising administering to the subject a pharmaceutical composition comprising about 4 g of ethyl icosapentate per day for a period of at least about 2 years, wherein the subject has a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL.
2. The method of claim 1 , wherein the composition is administered to the subject in 1 to 4 dosage units per day.
3. The method of claim 1 , wherein the ethyl icosapentate comprises at least about 96 wt. % of all omega-3 fatty acids in the pharmaceutical composition.
4. The method of claim 1 further comprising a step of measuring the subject's baseline lipid profile prior to administering the pharmaceutical composition to the subject.
5. The method of claim 1 , wherein the subject has one or more of: a baseline non-HDL-C value of about 200 mg/dL to about 300 mg/dL; a baseline total cholesterol value of about 250 mg/dL to about 300 mg/dL; a baseline VLDL-C value of about 140 mg/dL to about 200 mg/dL; a baseline HDL-C value of about 10 to about 30 mg/dL; and/or a baseline LDL-C value of about 40 to about 100 mg/dL.
6. The method of claim 1 , wherein the subject has: a baseline non-HDL-C value of about 200 mg/dL to about 300 mg/dL; a baseline total cholesterol value of about 250 mg/dL to about 300 mg/dL; a baseline VLDL-C value of about 140 mg/dL to about 200 mg/dL; a baseline HDL-C value of about 10 to about 30 mg/dL; and/or a baseline LDL-C value of about 40 to about 100 mg/dL.
7. The method of claim 1 , wherein the statin therapy comprises administering to the subject a statin and optionally ezetimibe.
8. The method of claim 1 , wherein the subject: (a) has not been administered 200 mg or more per day of niacin and/or fibrates for at least 28 days before administration of the pharmaceutical composition; (b) has not been administered omega-3 fatty acid prescription for a period of time beginning 28 days prior to administration of the pharmaceutical composition; or (c) has not ingested dietary supplements comprising omega-3 fatty acids for a period of time beginning 28 days prior to administration of the pharmaceutical composition.
9. The method of any of claim 8 , wherein the period of time ends no earlier than about 6 months after a first administration of the pharmaceutical composition.
10. The method of claim 8 , wherein the period of time ends about 6 months, about 1 year, about 2 years, about 3 years, about 4 years, about 5 years, or more than about 5 years after the first administration of the pharmaceutical composition.
11. The method of claim 1 , wherein the subject is administered about 4 g of the pharmaceutical composition per day for at least about 3 years.
12. The method of claim 1 , wherein the subject is administered about 4 g of the pharmaceutical composition per day for at least about 4 years.
13. The method of claim 1 , wherein the subject is administered about 4 g of the pharmaceutical composition per day for at least about 5 years.
14. The method of claim 1 , wherein the coronary revascularization is selected from elective coronary revascularization and emergent coronary revascularization.
15. The method of claim 1 , wherein the administration further reduces the risk of myocardial infarction in the subject.
16. The method of claim 1 , wherein the administration further reduces the risk of stroke in the subject.
17. The method of claim 1 , wherein the administration further reduces the risk of myocardial infarction or stroke in the subject.
18. The method of claim 17 , wherein the administration further reduces the risk of cardiovascular death in the subject.
19. A method of reducing a risk of coronary revascularization and/or unstable angina in a subject on statin therapy with established cardiovascular disease, the method comprising administering to the subject a pharmaceutical composition comprising about 4 g of ethyl icosapentate per day for a period of at least about 4 months, wherein the subject has a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL.
20. The method of claim 19 , wherein the established cardiovascular disease is determined by the presence of any one of: documented coronary artery disease, documented cerebrovascular disease, documented carotid disease, documented peripheral arterial disease, or combinations thereof.
21. The method of claim 19 , wherein the composition is administered to the subject in 1 to 4 dosage units per day.
22. The method of claim 19 , wherein the ethyl icosapentate comprises at least about 96 wt. % of all omega-3 fatty acids in the pharmaceutical composition.
23. The method of claim 19 , further comprising a step of measuring the subject's baseline lipid profile prior to administering the pharmaceutical composition to the subject.
24. The method of claim 19 , wherein the subject has one or more of: a baseline non-HDL-C value of about 200 mg/dL to about 300 mg/dL; a baseline total cholesterol value of about 250 mg/dL to about 300 mg/dL; a baseline VLDL-C value of about 140 mg/dL to about 200 mg/dL; a baseline HDL-C value of about 10 to about 30 mg/dL; and/or a baseline LDL-C value of about 40 to about 100 mg/dL.
25. The method of claim 19 , wherein the subject has: a baseline non-HDL-C value of about 200 mg/dL to about 300 mg/dL; a baseline total cholesterol value of about 250 mg/dL to about 300 mg/dL; a baseline VLDL-C value of about 140 mg/dL to about 200 mg/dL; a baseline HDL-C value of about 10 to about 30 mg/dL; and/or a baseline LDL-C value of about 40 to about 100 mg/dL.
26. The method of claim 19 , wherein the coronary revascularization is selected from elective coronary revascularization and emergent coronary revascularization.
27. The method of claim 19 , wherein the administration further reduces the risk of myocardial infarction in the subject.
28. The method of claim 19 , wherein the administration further reduces the risk of stroke in the subject.
29. The method of claim 19 , wherein the administration further reduces the risk of myocardial infarction and stroke in the subject.
30. The method of claim 29 , wherein the administration further reduces the risk of cardiovascular death in the subject.