# US 2013/0156852 A1 · Stable pharmaceutical composition and methods of using same > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0156852 A1 - Document ID: US20130156852A1 - Status: Published application - Kind: A1 - Application number: 13/768,897 - Filed: 2013-02-15 - Published: 2013-06-20 - Earliest claimed: 2009-04-29 - Assignees: Amarin Pharmaceuticals Ireland Limited - Inventors: Mehar Manku; Ian Osterloh; Pierre Wicker; Rene Braeckman; Paresh Soni - Web page: https://patentgrep.com/patent/US20130156852A1 ## CPC - A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557) - A61K 9/48: Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)} - A61K 9/4825: {Proteins, e.g. gelatin (gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816)} - A61K 9/4858: {Organic compounds} - A61K 31/232: having three or more double bonds, e.g. etretinate - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics - A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00) - A61P 3/04: Anorexiants; Antiobesity agents - A61P 3/06: Antihyperlipidemics - A61P 3/10: for hyperglycaemia, e.g. antidiabetics - A61P 7/02: Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors - A61P 7/10: Antioedematous agents; Diuretics - 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 - A61P 11/00: Drugs for disorders of the respiratory system - A61P 25/00: Drugs for disorders of the nervous system - 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 The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases. ## Claims ### Claim 1 A method of treating mixed dyslipidemia in a subject on statin therapy comprising, administering to the subject 2500 mg to 5000 mg per day of ethyl eicosapentaenoate, wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting triglycerides of at least 10% and a reduction in LDL-C compared to placebo control. ### Claim 2 (depends on 1) The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in LDL-C of at least 5% compared to placebo control. ### Claim 3 (depends on 1) The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting triglycerides of at least 15% compared to placebo control. ### Claim 4 (depends on 1) The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting triglycerides of at least 20% compared to placebo control. ### Claim 5 (depends on 1) The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting triglycerides of at least 25% compared to placebo control. ### Claim 6 (depends on 1) The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting apolipoprotein B compared to placebo control. ### Claim 7 (depends on 1) The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting VLDL-C compared to placebo control. ### Claim 8 (depends on 1) The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting VLDL-C of at least 5% compared to placebo control. ### Claim 9 (depends on 1) The method of claim 1 wherein the subject exhibits a reduction in hs-CRP compared to placebo control. ### Claim 10 (depends on 1) The method of claim 1 wherein the subject exhibits a reduction in non-HDL-C compared to placebo control. ### Claim 11 (depends on 1) The method of claim 1 wherein the subject exhibits a reduction in total cholesterol compared to placebo control. ### Claim 12 (depends on 1) The method of claim 1 wherein the subject exhibits a reduction in non-HDL-C, total cholesterol and VLDL-C compared to placebo control. ### Claim 13 (depends on 1) The method of claim 1 wherein the subject exhibits a reduction in oxidized LDL-C compared to placebo control. ### Claim 14 (depends on 1) The method of claim 1 wherein the subject exhibits a reduction in lipoprotein associated phospholipase A2 compared to placebo control. ### Claim 15 (depends on 1) The method of claim 1 wherein the ethyl eicosapentaenoate is administered to the subject in dosage units each comprising about 500 mg to about 1.5 g of ethyl eicosapentaenoate. ### Claim 16 (depends on 15) The method of claim 15 wherein the dosage units are capsules. ### Claim 17 (depends on 1) The method of claim 1 wherein the ethyl eicosapentaenoate is administered to the subject in dosage units each comprising about 900 mg to about 1 g of ethyl eicosapentaenoate. ### Claim 18 (depends on 17) The method of claim 17 wherein the dosage units are capsules. ### Claim 19 (depends on 1) The method of claim 1 wherein the ethyl eicosapentaenoate is administered to the subject in dosage units each comprising about 1 g of ethyl eicosapentaenoate. ### Claim 20 (depends on 19) The method of claim 19 wherein the dosage units are capsules. ### Claim 21 (depends on 1) The method of claim 1 wherein the ethyl eicosapentaenoate comprises at least about 90%, by weight, of all fatty acids.