# US 2014/0155481 A1 · Compositions and methods for lowering triglycerides in a subject on concomitant statin therapy > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0155481 A1 - Document ID: US20140155481A1 - Status: Published application - Kind: A1 - Application number: 14/176,631 - Filed: 2014-02-10 - Published: 2014-06-05 - Earliest claimed: 2009-06-15 - Assignees: Amarin Pharmaceuticals Ireland Limited - Applicants: Amarin Pharmaceuticals Ireland Limited - Inventors: Ian Osterloh; Pierre Wicker; Rene Braeckman; Paresh Soni; Mehar Manku - Web page: https://patentgrep.com/patent/US20140155481A1 ## CPC - A61K 31/232: having three or more double bonds, e.g. etretinate - A61K 9/48: Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)} - 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 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 - A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00) - A61P 3/06: Antihyperlipidemics - A61P 3/10: for hyperglycaemia, e.g. antidiabetics - A61P 7/00: Drugs for disorders of the blood or the extracellular fluid - A61P 9/00: Drugs for disorders of the cardiovascular system - A61P 9/04: Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure - A61P 9/06: Antiarrhythmics - A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis - A61P 9/12: Antihypertensives - C07C 57/03: Monocarboxylic acids - 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 - C07C: ACYCLIC OR CARBOCYCLIC COMPOUNDS ## Abstract In various embodiments, the present invention provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject in need thereof. ## Claims ### Claim 1 A method of lowering triglycerides in a subject on stable statin therapy having fasting triglycerides of about 200 mg/dl to less than 500 mg/dl comprising, administering to the subject on stable statin therapy from about 2 g to about 4 g per day of a pharmaceutical composition comprising at least 96% pure ethyl-EPA for a period effective to lower fasting triglycerides in the subject compared to a fasting triglyceride level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period. ### Claim 2 (depends on 1) The method of claim 1 wherein said period is about 1 to about 12 weeks. ### Claim 3 (depends on 2) The method of claim 2 wherein said period is about 1 to about 10 weeks. ### Claim 4 (depends on 3) The method of claim 3 wherein said period is about 1 to about 5 weeks. ### Claim 5 (depends on 2, 3, 4) The method of any one of claims 2-4 wherein the subject has serum LDL-C levels of about 40 mg/dl to about 115 mg/dl at a baseline prior to administration of the composition. ### Claim 6 (depends on 5) The method of claim 5 wherein upon administering the composition to the subject daily for said period, the subject exhibits a reduction in fasting VLDL-C compared to a fasting VLDL-C level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period. ### Claim 7 (depends on 6) The method of claim 6, wherein upon administering the composition to the subject daily for said period, the subject exhibits at least a 20% reduction in fasting triglycerides compared to a fasting triglyceride level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period. ### Claim 8 (depends on 7) The method of claim 7, wherein upon administering the composition to the subject daily for said period, the subject exhibits at least a 25% reduction in fasting triglycerides compared to a fasting triglyceride level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period. ### Claim 9 (depends on 8) The method of claim 8, wherein upon administering the composition to the subject daily for said period, the subject exhibits a reduction in fasting LDL-C compared to a fasting LDL-C level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period. ### Claim 10 (depends on 1) The method of claim 1, wherein the subject consumes a Western diet. ### Claim 11 (depends on 1) The method of claim 1, wherein the subject is at LDL-C goal at time of said initial administration of the composition. ### Claim 12 (depends on 1) The method of claim 1, wherein the subject has a fasting LDL-C level of about 40 mg/dl to about 100 mg/dl and a fasting triglyceride level of about 200 mg/dl to about 500 mg/dl immediately prior to initial administration of the composition. ### Claim 13 A method of lowering triglycerides in a subject on stable statin therapy having fasting triglycerides of about 200 mg/dl to less than 500 mg/dl and a fasting LDL-C level of about 40 mg/dl to about 100 mg/dl comprising, administering to the subject 2 g to about 4 g per day of a pharmaceutical composition comprising at least 96% pure ethyl-EPA for a period effective to lower fasting triglycerides in the subject. ### Claim 14 (depends on 13) The method of claim 13 wherein upon administering the composition to the subject for said period, the subject exhibits a reduction in fasting non-LDL compared to a fasting non-LDL level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period. ### Claim 15 (depends on 13) The method of claim 13 wherein upon administering the composition to the subject daily for said period, the subject exhibits a reduction in fasting VLDL-C compared to a fasting VLDL-C level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period. ### Claim 16 (depends on 13) The method of claim 13 wherein upon administering the composition to the subject daily for said period, the subject exhibits a reduction in fasting non-HDL-C compared to a fasting non-HDL-C level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period. ### Claim 17 (depends on 13) The method of claim 13 wherein upon administering the composition to the subject daily for said period, the subject exhibits a reduction in fasting total cholesterol compared to a fasting total cholesterol level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period. ### Claim 18 (depends on 13) The method of claim 13 where said period is about 1 to about 12 weeks ### Claim 19 (depends on 13) The method of claim 13 where said period is about 1 to about 10 weeks. ### Claim 20 (depends on 13) The method of claim 13 wherein said period is about 1 to about 5 weeks. ### Claim 21 A method of lowering triglycerides in a subject on stable statin therapy having fasting triglycerides of about 200 mg/dl to less than 500 mg/dl comprising, administering to the subject on statin therapy from 2 g to 4 g per day of a pharmaceutical composition comprising at least 96% pure ethyl-EPA for a period of about 1 to about 12 weeks thereby to lower fasting triglycerides in the subject by least 25% compared to a fasting triglyceride level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period, and wherein administration of the composition does not result in a statistically significant increase in fasting LDL-C compared to a fasting LDL-C level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period.