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1. EP2777701 - Composition for preventing the occurrence of a cardiovascular event in multiple risk patient comprising the ethyl ester of all-cis-5,8,11,14,17-icosapentaenoic acid

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Claims

1. A composition for use in the primary prevention of a cardiovascular event in a hypercholesterolemia patient, wherein the composition comprises the ethyl ester of all-cis-5,8,11,14,17-icosapentaenoic acid as its effective component and is used in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor,
wherein the cardiovascular event is cardiovascular death, fatal myocardial infarction, sudden cardiac death, nonfatal myocardial infarction, cardiovascular angioplasty, or new occurrence of rest angina and exercise-induced angina, and wherein said patient is a male patient and suffers from two or more of the 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.


  2. The composition for use 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; 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-C of less than 40 mg/dL.
  3. The composition for use according to claim 1 or 2, wherein the content of the ethyl ester of all-cis-5,8,11,14,17-icosapentaenoic acid is at least 96.5% by weight in relation to the total content of fatty acid and derivatives thereof.
  4. The composition for use according to any one of claims 1 to 3, wherein the ethyl ester of all-cis-5,8,11,14,17-icosapentaenoic acid is orally administered at a dose of 0.3 g/day to 6 g/day.
  5. The composition for use according to any one of claims 1 to 4, wherein the ethyl ester of all-cis-5,8,11,14,17-icosapentaenoic acid is orally administered at a dose of 1.8 g/day to 2.7 g/day.
  6. A composition for use in the primary prevention of a cardiovascular event in a hypercholesterolemia patient, wherein the composition comprises the ethyl ester of all-cis-5,8,11,14,17-icosapentaenoic acid as its effective component and is used in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor,
wherein the cardiovascular event is cardiovascular death, fatal myocardial infarction, sudden cardiac death, nonfatal myocardial infarction, cardiovascular angioplasty, or new occurrence of rest angina and exercise-induced angina, and wherein said patient also suffers from the following risk factors:

(1) obesity,

(2) hypertension or prehypertension,

(3) diabetes, prediabetes, or abnormal glucose tolerance, and

(4) hypertriglyceridemia and/or low HDL cholesterolemia.


  7. The composition for use according to claim 6, 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-C of less than 40 mg/dL.
  8. The composition for use according to claim 6 or 7, wherein the content of the ethyl ester of all-cis-5,8,11,14,17-icosapentaenoic acid is at least 96.5% by weight in relation to the total content of fatty acid and derivatives thereof.
  9. The composition for use according to any one of claims 6 to 8, wherein the ethyl ester of all-cis-5,8,11,14,17-icosapentaenoic acid is orally administered at a dose of 0.3 g/day to 6 g/day.
  10. The composition for use according to any one of claims 6 to 9, wherein the ethyl ester of all-cis-5,8,11,14,17-icosapentaenoic acid is orally administered at a dose of 1.8 g/day to 2.7 g/day.
  11. The composition for use according to any one of claims 6 to 10, wherein the hypercholesterolemia patient is a male patient.