Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease

• US 10,576,054 B1
• Filed: 11/15/2019
• Issued: 03/03/2020
• Est. Priority Date: 06/29/2012
• Status: Active Grant

• Current Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Original Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Inventors: Soni, Paresh
• Primary Examiner(s): Vajda, Kristin A
• Application Number:
  US16/685,628
• Publication Number:
  US 20200078329A1
• Time in Patent Office: 109 Days
• Field of Search: 514549
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/232 having three or more double bonds, e.g. etretinate
• CPC Class Codes: A61K 31/397 having four-membered rings, e.g. azetidine
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/04 Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
• CPC Class Codes: A61P 9/06 Antiarrhythmics
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

In various embodiments, the present invention provides methods of reducing the risk of a cardiovascular event in a subject on statin therapy and, in particular, a method of reducing the risk of a cardiovascular event in a subject on statin therapy having a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL, and 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

1. A method of delaying or preventing a major adverse cardiovascular event in a subject, the method comprising administering about 4 g per day of icosapent ethyl to the subject for a period effective to delay or prevent the major adverse cardiovascular event, wherein the subject is 50 years of age or older, has diabetes and at least one additional risk factor for cardiovascular disease.

2. The method of claim 1, wherein the at least one additional risk factor is selected from hypertension, smoking, retinopathy and albuminuria.

3. The method of claim 1, wherein the subject has at least two additional risk factors for cardiovascular disease.

4. The method of claim 1, wherein subject has a baseline triglyceride level of at least 200 mg/dL.

5. The method of claim 1, wherein the major adverse cardiovascular event is selected from the group consisting of stroke, myocardial infarction, coronary revascularization, unstable angina and cardiovascular death.

6. The method of claim 1, wherein the subject is on a statin therapy.

7. The method of claim 6, wherein the statin therapy is a stable statin therapy.

8. The method of claim 1, wherein the icosapent ethyl is present in a pharmaceutical composition and the icosapent ethyl comprises at least about 96 wt. % of all omega-3 fatty acids in the pharmaceutical composition.

9. The method of claim 8, wherein about 1 g of the pharmaceutical composition is present in each of 4 capsules.