# US 11,298,333 B1 · Methods of reducing the risk of cardiovascular events in a subject > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,298,333 B1 - Document ID: US11298333B1 - Status: Granted - Kind: B1 - Application number: 17/400,428 - Filed: 2021-08-12 - Granted: 2022-04-12 - Earliest claimed: 2018-09-24 - Assignees: Amarin Pharmaceuticals Ireland Limited - Applicants: Amarin Pharmaceuticals Ireland Limited - Inventors: Paresh Soni - Web page: https://patentgrep.com/patent/US11298333B1 ## CPC - A61K 31/232: having three or more double bonds, e.g. etretinate - A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration} - A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557) - A61K 31/366: having six-membered rings, e.g. delta-lactones - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 9/00: Drugs for disorders of the cardiovascular system - A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis - A61K 31/40: having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil - A61K 31/505: Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract In various embodiments, the present disclosure provides methods reducing the risk of cardiovascular events in a subject on statin therapy by administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof. ## Claims ### Claim 1 A method of reducing an incidence of myocardial infarction in a subject with triglyceride levels of greater than 150 mg/dl, said method comprising administering to said subject 4 g of icosapent ethyl, wherein the subject experiences atrial fibrillation and/or flutter instead of an incidence of myocardial infarction. ### Claim 2 (depends on 1) The method of claim 1, wherein the subject has previously had atrial fibrillation and/or flutter. ### Claim 3 (depends on 1) The method of claim 1, wherein the subject has atrial fibrillation and/or flutter. ### Claim 4 (depends on 1) The method of claim 1, wherein the subject has not and does not have atrial fibrillation and/or flutter. ### Claim 5 (depends on 1) The method of claim 1, wherein the subject is on statin therapy. ### Claim 6 (depends on 1) The method of claim 1, wherein the statin therapy is a high intensity statin regimen, wherein the subject is administered about 40 mg to about 80 mg per day of atorvastatin or about 20 mg to about 40 mg per day of rosuvastatin. ### Claim 7 (depends on 1) The method of claim 1, wherein the subject has (1) established cardiovascular disease, or (2) diabetes and at least 2 additional risk factors for cardiovascular disease. ### Claim 8 (depends on 1) The method of claim 1, wherein the subject has triglyceride levels of about 135 mg/dL to about 500 mg/dL. ### Claim 9 (depends on 1) The method of claim 1, wherein the subject has a baseline LDL-C level of about 40 mg/dL to about 100 mg/dL. ### Claim 10 (depends on 1) The method of claim 1, wherein the ethyl icosapentate is present in a pharmaceutical composition and the ethyl icosapentate comprises at least about 96 wt. % of all omega-3 fatty acids in the pharmaceutical composition. ### Claim 11 (depends on 4) The method of claim 4, wherein about 1 g of the pharmaceutical composition is present in each of 4 capsules. ### Claim 12 (depends on 1) The method of claim 1, wherein the subject is administered the icosapent ethyl for a period of at least about 2 years. ### Claim 13 (depends on 1) The method of claim 1, wherein the subject exhibits an increase in symptoms of atrial fibrillation and/or flutter by at least about 1%. ### Claim 14 (depends on 1) The method of claim 1, wherein the subject exhibits an increase in symptoms of atrial fibrillation and/or flutter by at least about 2%. ### Claim 15 (depends on 1) The method of claim 1, wherein the subject exhibits an increase in symptoms of atrial fibrillation and/or flutter by at least about 3%. ### Claim 16 (depends on 1) The method of claim 1, wherein the subject exhibits an increase in symptoms of atrial fibrillation and/or flutter by at least about 4%. ### Claim 17 (depends on 1) The method of claim 1, wherein the subject exhibits an increase in symptoms of atrial fibrillation and/or flutter by at least about 5%.