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1. US20140371312 - COMPOSITION FOR PREVENTING THE OCCURRENCE OF CARDIOVASCULAR EVENT IN MULTIPLE RISK PATIENT

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Claims

1. A method of reducing occurrence of a cardiovascular event in a hypercholesterolemia patient comprising,
identifying a patient having triglyceride (TG) of at least 150 mg/dL and HDL-Cholesterol (HDL-C) of less than 40 mg/dL in a blood sample taken from the patient, wherein the patient has not previously had a cardiovascular event, and administering ethyl icosapentate and/or icosapentaenoic acid in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, wherein the patient optionally also suffers from at least one risk factor selected from the group consisting of:
(1) obesity,
(2) hypertension or prehypertension, and
(3) diabetes, prediabetes, or abnormal glucose tolerance.
2. The method according to claim 1, wherein the obesity is defined by a body mass index (BMI) of at least 25; the hypertension or the prehypertension is defined by a systolic blood pressure (SBP) of at least 140 mmHg or a diastolic blood pressure (DBP) of at least 90 mmHg; and the diabetes, the prediabetes, or the abnormal glucose tolerance is defined by a fasting blood glucose (FBS) of at least 126 mg/dL or a hemoglobin A1c (HbA1c) of at least 6.5%.
3. The method according to claim 1, wherein the hypercholesterolemia patient is a male patient.
4. The method according to claim 1, which comprises administering a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor to the patient at least one of before, during and after said administering the ethyl icosapentate and/or icosapentaenoic acid.
5. The method according to claim 1, wherein the ethyl icosapentate and/or icosapentaenoic acid is administered daily for two years or more.
6. The method according to claim 1, wherein the cardiovascular event is a fatal cardiovascular event.
7. The method according to claim 1, wherein the hypercholesterolemia patient has a serum [triglyceride (TG)/HDL-Cholesterol (HDL-C)] ratio of at least 3.75.
8. A method of reducing occurrence of a cardiovascular event in a hypercholesterolemia patient comprising,
identifying the patient has not previously had a cardiovascular event, and administering ethyl icosapentate and/or icosapentaenoic acid in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, wherein the patient also suffers from the following (1)-(4):
(1) obesity,
(2) hypertension or prehypertension,
(3) diabetes, prediabetes, or abnormal glucose tolerance, and
(4) hypertriglyceridemia and/or low HDL cholesterolemia.
9. The method according to claim 8, wherein the obesity is defined by a body mass index (BMI) of at least 25; the hypertension or the prehypertension is defined by a systolic blood pressure (SBP) of at least 140 mmHg or a diastolic blood pressure (DBP) of at least 90 mmHg; and the diabetes, the prediabetes, or the abnormal glucose tolerance is defined by a fasting blood glucose (FBS) of at least 126 mg/dL or a hemoglobin Ale (HbA1c) of at least 6.5%; and the hypertriglyceridemia and/or the low HDL cholesterolemia is defined by triglyceride (TG) of at least 150 mg/dL and/or a HDL-Cholesterol (HDL-C) of less than 40 mg/dL.
10. The method according to claim 8, wherein the hypercholesterolemia patient is a male patient.
11. The method according to claim 8, which comprises administering a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor to the patient at least one of before, during and after said administering the ethyl icosapentate and/or icosapentaenoic acid.
12. The method according to claim 8, wherein the ethyl icosapentate and/or icosapentaenoic acid is administered daily for two years or more.
13. The method according to claim 8, wherein the cardiovascular event is a fatal cardiovascular event.
14. The method according to claim 8, wherein the hypercholesterolemia patient has a serum [triglyceride (TG)/HDL-Cholesterol (HDL-C)] ratio of at least 3.75.
15. A method of reducing occurrence of a cardiovascular event in a male hypercholesterolemia patient comprising,
identifying the male patient has not previously had a cardiovascular event, and administering ethyl icosapentate and/or icosapentaenoic acid in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, wherein the patient also suffers from at least two risk factors selected from the group consisting of:
(1) obesity,
(2) hypertension or prehypertension,
(3) diabetes, prediabetes, or abnormal glucose tolerance, and
(4) hypertriglyceridemia and/or low HDL cholesterolemia.
16. The method according to claim 15, wherein the obesity is defined by a body mass index (BMI) of at least 25; the hypertension or the prehypertension is defined by a systolic blood pressure (SBP) of at least 140 mmHg or a diastolic blood pressure (DBP) of at least 90 mmHg; the diabetes, the prediabetes, or the abnormal glucose tolerance is defined by a fasting blood glucose (FBS) of at least 126 mg/dL or a hemoglobin A1c (HbA1c) of at least 6.5%; and the hypertriglyceridemia and/or the low HDL cholesterolemia is defined by triglyceride (TG) of at least 150 mg/dL and/or a HDL-Cholesterol (HDL-C) of less than 40 mg/dL.
17. The method according to claim 15, which comprises administering a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor to the patient at least one of before, during and after said administering the ethyl icosapentate and/or icosapentaenoic acid.
18. The method according to claim 15, wherein the ethyl icosapentate and/or icosapentaenoic acid is administered daily for two years or more.
19. The method according to claim 15, wherein the cardiovascular event is a fatal cardiovascular event.
20. The method according to claim 15, wherein the hypercholesterolemia patient has a serum [triglyceride (TG)/HDL-Cholesterol (HDL-C)] ratio of at least 3.75.
21. The method according to claim 1, wherein the content of the ethyl icosapentate and/or icosapentaenoic acid is at least 40% by weight in relation to the total content of fatty acid and derivatives thereof.
22. The method according to claim 21, wherein the content of the ethyl icosapentate is at least 96.5% by weight in relation to the total content of fatty acid and derivatives thereof.
23. The method according to claim 21, wherein the content of the icosapentaenoic acid is at least 40% by weight in relation to the total content of fatty acid and derivatives thereof.
24. The method according to claim 1, wherein the ethyl icosapentate and/or icosapentaenoic acid is orally administered at a dose of 0.3 g/day to 6 g/day.
25. The method according to claim 24, wherein the ethyl icosapentate and/or icosapentaenoic acid is orally administered at a dose of 1.8 g/day to 6 g/day.
26. The method according to claim 24, wherein the ethyl icosapentate and/or icosapentaenoic acid is orally administered at a dose of 1.8 g/day to 2.7 g/day.
27. The method according to claim 8, wherein the content of the ethyl icosapentate and/or icosapentaenoic acid is at least 40% by weight in relation to the total content of fatty acid and derivatives thereof.
28. The method according to claim 27, wherein the content of the ethyl icosapentate is at least 96.5% by weight in relation to the total content of fatty acid and derivatives thereof.
29. The method according to claim 27, wherein the content of the icosapentaenoic acid is at least 40% by weight in relation to the total content of fatty acid and derivatives thereof.
30. The method according to claim 8, wherein the ethyl icosapentate and/or icosapentaenoic acid is orally administered at a dose of 0.3 g/day to 6 g/day.
31. The method according to claim 30, wherein the ethyl icosapentate and/or icosapentaenoic acid is orally administered at a dose of 1.8 g/day to 6 g/day.
32. The method according to claim 30, wherein the ethyl icosapentate and/or icosapentaenoic acid is orally administered at a dose of 1.8 g/day to 2.7 g/day.
33. The method according to claim 15, wherein the content of the ethyl icosapentate and/or icosapentaenoic acid is at least 40% by weight in relation to the total content of fatty acid and derivatives thereof.
34. The method according to claim 33, wherein the content of the ethyl icosapentate is at least 96.5% by weight in relation to the total content of fatty acid and derivatives thereof.
35. The method according to claim 33, wherein the content of the icosapentaenoic acid is at least 40% by weight in relation to the total content of fatty acid and derivatives thereof.
36. The method according to claim 15, wherein the ethyl icosapentate and/or icosapentaenoic acid is orally administered at a dose of 0.3 g/day to 6 g/day.
37. The method according to claim 36, wherein the ethyl icosapentate and/or icosapentaenoic acid is orally administered at a dose of 1.8 g/day to 6 g/day.
38. The method according to claim 36, wherein the ethyl icosapentate and/or icosapentaenoic acid is orally administered at a dose of 1.8 g/day to 2.7 g/day.