Methods of treating mixed dyslipidemia
The present disclosure relates to, inter alia, methods of treating mixed dyslipidemia with ethyl eicosapentaenoate.
1. A pharmaceutical composition comprising a mixture of ethyl-EPA and ethyl-DHA in a ratio of about 2:1 to about 3.5:1, Polysorbate 80 in an amount from about 0.25% to about 15%, by weight of the pharmaceutical composition and polyoxypropylene block copolymer in an amount from about 0.25% to about 15%, by weight, of the pharmaceutical composition.
2. The pharmaceutical composition of claim 1 further comprising at least one antioxidant.
3. The pharmaceutical composition of claim 2 wherein the at least one antioxidant is a tocopherol.
4. The pharmaceutical composition of claim 3 wherein the tocopherol comprises from about 0.0001% to about 5% of the total weight of the pharmaceutical composition.
5. A method of treating a cardiovascular-related disease in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a composition comprising eicosapentaenoic acid (EPA) or a derivative of EPA, docosahexaenoic acid (DHA) or a derivative of DHA, and at least one surfactant, wherein the subject has baseline triglyceride levels of at least about 500 mg/dL.
6. The method of claim 5 wherein the cardiovascular-related disease is selected from the group consisting of acute cardiac ischemic events, acute myocardial infarction, angina, angina pectoris, arrhythmia, atrial fibrillation, atherosclerosis, arterial fibrillation, cardiac insufficiency, cardiovascular disease, chronic heart failure, chronic stable angina, congestive heart failure, coronary artery disease, coronary heart disease, deep vein thrombosis, diabetic neuropathy, diastolic dysfunction in subjects with diabetes mellitus, edema, essential hypertension, eventual pulmonary embolism, fatty liver disease, heart disease, heart failure, homozygous familial hypercholesterolemia (HoFH), homozygous familial sitosterolemia, hypercholesterolemia, ischemic complications in unstable angina and myocardial infarction, low blood pressure, metabolic syndrome, moderate to mild heart failure, myocardial infarction, obesity management, paroxysmal atrial/arterial fibrillation/fibrulation/flutter, paroxysmal supraventricular tachycardias (PSVT), particularly severe or rapid onset edema, platelet aggregation, primary hypercholesterolemia, primary hyperlipidemia, pulmonary arterial hypertension, pulmonary hypertension, recurrent hemodynamically unstable ventricular tachycardia (VT), recurrent ventricular arrhythmias, recurrent ventricular fibrillation (VF), ruptured aneurysm, sitisterolemia, stroke, supraventricular tachycardia, symptomatic atrial fibrillation/flutter, tachycardia, type-II diabetes, vascular disease, venous thromboembolism, ventricular arrhythmias, and combinations thereof.
7. The method of claim 6 wherein the cardiovascular-related disease is hypertriglyceridemia.
8. The method of claim 5 wherein the composition is administered to the subject in 1 to about 10 dosage units per day.
9. The method of claim 8 wherein the dosage units comprise capsules.
10. The method of claim 5 wherein the composition further comprises at least one additional fatty acid selected from the group consisting of linolenic acid (LA), derivative of LA, arachidonic acid (AA), derivative of AA, alpha-linolenic acid (ALA), derivative of ALA, stearidonic acid (STA), derivative of STA, eicosatrienoic acid (ETA), derivative of ETA, docosapentaenoic acid (DPA), derivative of DPA, or combinations thereof.
11. The method of claim 5 wherein the derivative of EPA is ethyl-EPA.
12. The method of claim 5 wherein the derivative of DHA is ethyl-DHA.
13. The method of claim 5 wherein the at least one surfactant is selected from the group consisting a polysorbate, a poloxamer, or combinations thereof.
14. The method of claim 13 wherein the at least one polysorbate is present in an amount from about 0.25% to about 15%, by weight, of the composition.
15. The method of claim 14 wherein the at least one polysorbate is Polysorbate 80.
16. The method of claim 13 wherein the at least one poloxamer is present in an amount from about 0.25% to about 15%, by weight, of the composition.
17. The method of claim 5 wherein the at least one surfactant comprises a mixture of Polysorbate 80 and a poloxamer.
18. The method of claim 5 wherein the composition further comprises at least one antioxidant.
19. The method of claim 18 wherein the at least one antioxidant is a tocopherol.
20. The method of claim 19 wherein the tocopherol comprises from about 0.0001% to about 5% of the total weight of the composition.