US2014371312A1PendingUtilityA1

Composition for preventing the occurrence of cardiovascular event in multiple risk patient

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Assignee: MOCHIDA PHARM CO LTDPriority: May 31, 2006Filed: Sep 2, 2014Published: Dec 18, 2014
Est. expiryMay 31, 2026(expired)· nominal 20-yr term from priority
Inventors:Mitsuhiro YokoyamaHideki OrigasaMasunori MatsuzakiYuji MatsuzawaYasushi Saito
A61P 9/14A61P 9/10A61P 9/12A61P 43/00A61P 3/06A61P 7/00A61P 9/00A61P 3/10A61K 31/225A61P 3/04A61K 31/351A61K 31/40A61K 31/366A61K 2300/00A61K 31/232A61K 31/202A61K 45/06A61K 31/22
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Claims

Abstract

Disclosed is a composition which is useful for preventing the occurrence of a cardiovascular event, particularly a composition which is expected to show a prophylactic effect on a cardiovascular event occurring in a hypercholesterolemia patient despite providing the patient with a treatment with HMG-CoA RI or a cardiovascular event occurring in a multiple risk patient.

Claims

exact text as granted — not AI-modified
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.

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