Claims for Patent: 9,700,537

Summary for Patent: 9,700,537

Title:	Composition for preventing the occurrence of cardiovascular event in multiple risk patient
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.
Inventor(s):	Yokoyama; Mitsuhiro (Kobe, JP), Origasa; Hideki (Toyama, JP), Matsuzaki; Masunori (Ube, JP), Matsuzawa; Yuji (Takarzuka, JP), Saito; Yasushi (Chiba, JP)
Assignee:	MOCHIDA PHARMACEUTICAL CO., LTD. (Tokyo, JP)
Application Number:	15/431,958
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,700,537
Patent Claims:	1. A method of reducing occurrence of a cardiovascular event in a hypercholesterolemia patient consisting of: identifying a patient having triglycerides (TG) of at least 150 mg/DL and HDL-C of less than 40 mg/dL in a blood sample taken from the patient as a risk factor of a cardiovascular event, wherein the patient has not previously had a cardiovascular event, and administering ethyl icosapentate in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, 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 selected from the group consisting of pravastatin, lovastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin, and salts thereof, and wherein daily dose of the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor are 5 to 60 mg for pravastatin, 2.5 to 60 mg for simvastatin, 10 to 180 mg for fluvastatin sodium, 5 to 120 mg for atorvastatin calcium hydrate, 0.5 to 12 mg for pitavastatin calcium, 1.25 to 60 mg for rosuvastatin calcium, 5 to 160 mg for lovastatin, and 0.075 to 0.9 mg for cerivastatin sodium. 2. 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. 3. The method according to claim 1, wherein the hypercholesterolemia patient is a male patient. 4. The method according to claim 1, wherein the ethyl icosapentate is administered daily for two years or more. 5. The method according to claim 1, wherein the cardiovascular event is a fatal cardiovascular event. 6. The method according to claim 1, wherein the hypercholesterolemia patient has a serum [triglyceride (TG)/HDL-C] ratio of at least 3.75. 7. 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. 8. 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 that is simultaneously administered with the ethyl icosapentate. 9. A method of reducing occurrence of a cardiovascular event in a hypercholesterolemia patient consisting of: identifying a patient having (i) total cholesterol (TC) of at least 220 mg/dL or LDL-cholesterol (LDL-C) of at least 140 mg/dL, and (ii) triglycerides (TG) of at least 150 mg/dL and HDL-C of less than 40 mg/dL in a blood sample taken from the patient as a risk factors of a cardiovascular event, wherein the patient has not previously had a cardiovascular event, and administering ethyl icosapentate in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, 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 selected from the group consisting of pravastatin, lovastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin, and salts thereof, and wherein daily dose of the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor are 5 to 60 mg for pravastatin, 2.5 to 60 mg for simvastatin, 10 to 180 mg for fluvastatin sodium, 5 to 120 mg for atorvastatin calcium hydrate, 0.5 to 12 mg for pitavastatin calcium, 1.25 to 60 mg for rosuvastatin calcium, 5 to 160 mg for lovastatin, and 0.075 to 0.9 mg for cerivastatin sodium. 10. The method according to claim 9, wherein the ethyl icosapentate is orally administered at a dose of 1.8 g/day to 2.7 g/day. 11. The method according to claim 9, wherein the hypercholesterolemia patient is a male patient. 12. The method according to claim 9, wherein the ethyl icosapentate is administered daily for two years or more. 13. The method according to claim 9, wherein the cardiovascular event is a fatal cardiovascular event. 14. The method according to claim 9, wherein the hypercholesterolemia patient has a serum [triglyceride (TG)/HDL-C] ratio of at least 3.75. 15. The method according to claim 9, wherein the ethyl icosapentate is orally administered at a dose of 0.3 g/day to 6 g/day. 16. The method according to claim 9, wherein the content of the ethyl icosapentate is at least 96.5% by weight in relation to the total content of fatty acid that is simultaneously administered with the ethyl icosapentate.