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1. US20170273928 - 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 the steps of:
administering daily ethyl icosapentate in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor to the patient;
wherein the patient also suffers from four risk factors comprising:
(1) obesity,
(2) hypertension or prehypertension,
(3) diabetes, prediabetes, or abnormal glucose tolerance, and
(4) hypertriglyceridemia and/or low HDL cholesterolemia;
wherein the patient has not previously had a cardiovascular event,
wherein the rate of suppression of the cardiovascular event occurrence in the said administered patient group is equal to or more than 40% compared to the control patient group after 2 years or more from the start of said administration,
wherein said 3-hydroxyl-3-methylglutaryl coenzyme A reductase inhibitor is administered to the patient at least one of before, during and after administering the ethyl icosapentate, and
wherein the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor is one or more of pravastatin, lovastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin, and salts thereof.
2. The method according to claim 1, wherein the four risk factors of the (1) to (4) of claim 1 is defined by a body mass index (BMI) of at least 25 for the obesity; by a systolic blood pressure (SBP) of at least 140 mmHg or a diastolic blood pressure (DBP) of at least 90 mmHg for the hypertension or the prehypertension; by a fasting blood glucose (FBS) of at least 126 mg/dL or a hemoglobin Ale (HbA1c) of at least 6.5% for the diabetes, the prediabetes, or the abnormal glucose tolerance; and by triglyceride (TG) of at least 150 mg/dL and/or a HDL-cholesterol (HDL C) of less than 40 mg/dL for the hypertriglyceridemia and/or the low HDL cholesterolemia.
3. The method according to claim 1, wherein the ethyl icosapentate is orally administered at a dose of 1.8 g/day to 2.7 g/day.
4. The method according to claim 1, wherein the hypercholesterolemia patient has total cholesterol (TC) of at least 220 mg/dL or LDL-cholesterol (LDL-C) of at least 140 mg/dL.
5. The method according to claim 1, wherein the ethyl icosapentate 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-C] ratio of at least 3.75.
8. The method according to claim 1, wherein the ethyl icosapentate is orally administered at a dose of 0.3 g/day to 6 g/day.
9. The method according to claim 1, 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 that are simultaneously administered with the ethyl icosapentate.
10. A method of reducing occurrence of a cardiovascular event in a hypercholesterolemia male patient, comprising the steps of:
administering daily ethyl icosapentate in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor to the patient,
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,
wherein the patient has not previously had a cardiovascular event;
wherein said 3-hydroxyl-3-methylglutaryl coenzyme A reductase inhibitor is administered to the patient at least one of before, during and after administering the ethyl icosapentate;
wherein the rate of suppression of the cardiovascular event occurrence in the said administered patient group is equal to or more than 55% compared to the control patient group after 2 years or more from the start of said administration, and
wherein the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor is one or more of pravastatin, lovastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin, and salts thereof.
11. The method according to claim 10, wherein the at least 2 risk factors is defined by a body mass index (BMI) of at least 25 for the obesity; by a systolic blood pressure (SBP) of at least 140 mmHg or a diastolic blood pressure (DBP) of at least 90 mmHg for the hypertension or the prehypertension; by a fasting blood glucose (FBS) of at least 126 mg/dL or a hemoglobin Ale (HbA1c) of at least 6.5% for the diabetes, the prediabetes, or the abnormal glucose tolerance; and by triglyceride (TG) of at least 150 mg/dL and/or a HDL-cholesterol (HDL-C) of less than 40 mg/dL for the hypertriglyceridemia and/or the low HDL cholesterolemia.
12. The method according to claim 10, wherein the ethyl icosapentate is orally administered at a dose of 1.8 g/day to 2.7 g/day.
13. The method according to claim 10, wherein the hypercholesterolemia patient has total cholesterol (TC) of at least 220 mg/dL or LDL-cholesterol (LDL-C) of at least 140 mg/dL.
14. The method according to claim 10, wherein the ethyl icosapentate is administered daily for two years or more.
15. The method according to claim 10, wherein the cardiovascular event is a fatal cardiovascular event.
16. The method according to claim 10, wherein the patient has a serum [triglyceride (TG)/HDL-C] ratio of at least 3.75.
17. The method according to claim 10, wherein the ethyl icosapentate is orally administered at a dose of 0.3 g/day to 6 g/day.
18. The method according to claim 10, 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 that are simultaneously administered with the ethyl icosapentate.