Amarin's Patents, posted the claims to the patents that prevent AZN from launching Epanova without infringement...as I said...the work around is a $15 Billion check. Amarin has locked the EPA molecule regardless of FA, EE, or mix (potent enough not to raise LDL)... Also locked combo with EE FA Mix and statin combo.
Also, AZN has been unable to list MG of EPA and MG of other Omega's, the FDA should have never approved such a product. Amarin could sue to remove all Epanova Orange book patent...but this is another post.
Amarin has numerous applications all at various stages of prosecution.
BB
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8613945
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
We claim:
1. A method of treating high triglycerides in a subject receiving statin therapy comprising, administering to the subject daily for a period effective to reduce triglycerides in the subject a pharmaceutical composition comprising: an amount of eicosapentaenoic acid selected from the group consisting of about 1100 mg, about 1650 mg and about 2200 mg; and not more than about 20% docosahexaenoic acid, by weight of fatty acids present.
2. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce triglycerides by at least 10% in the subject.
3. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce triglycerides by at least 15% in the subject.
4. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce non-HDL-C in the subject.
5. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce non-HDL-C by at least about 5% in the subject.
6. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to increase HDL-C in the subject.
7. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce lipoprotein associated phospholipase A2 in the subject.
8. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce lipoprotein associated phospholipase A2 by at least 5% in the subject.
9. The method of claim 1 wherein the effective amount of eicosapentaenoic acid is about 1100 mg.
10. The method of claim 9 wherein said administration results in an increase in plasma eicosapentaenoic acid levels of at least 200% in the subject.
11. The method of claim 1 wherein the effective amount of eicosapentaenoic acid is about 1650 mg.
12. The method of claim 11 wherein said administration results in an increase in plasma eicosapentaenoic acid levels of at least 200% in the subject.
13. The method of claim 1 wherein the effective amount of eicosapentaenoic acid is about 2200 mg.
14. The method of claim 13 wherein said administration results in an increase in plasma eicosapentaenoic acid levels of at least 400% in the subject.
15. The method of claim 1 wherein the pharmaceutical composition comprises about 20%, by weight of total fatty acids, docosahexaenoic acid.
16. The method of claim 1 wherein the period is at least about 12 weeks.
8617593
Stable pharmaceutical composition and methods of using same
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.
We claim:
1. A method of treating hypertriglyceridemia in a subject on statin therapy comprising, administering to the subject daily a pharmaceutical composition comprising about 2500 mg to about 5000 mg of ethyl eicosapentaenoate and not more than about 5% docosahexaenoic acid or its esters, by weight of all fatty acids.
2. 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.
3. 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 baseline.
4. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting apolipoprotein B compared to baseline.
5. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in fasting VLDL-C compared to baseline.
6. 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 baseline.
7. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in hs-CRP compared to baseline.
8. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in non-HDL-C compared to baseline.
9. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in total cholesterol compared to baseline.
10. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in non-HDL-C, triglycerides and VLDL-C compared to baseline.
11. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in oxidized LDL-C compared to baseline.
12. The method of claim 1 wherein upon 12 weeks of said administration the subject exhibits a reduction in lipoprotein associated phospholipase A2 compared to baseline.
13. 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.
14. The method of claim 13 wherein the dosage units are capsules.
15. 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.
16. The method of claim 15 wherein the dosage units are capsules.
17. 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.
18. The method of claim 17 wherein the dosage units are capsules.
19. The method of claim 1 wherein the ethyl eicosapentaenoate comprises at least about 90%, by weight, of all fatty acids.
20. The method of claim 1 wherein the fatty acid composition is added to the statin administration after the statin administration has been deemed inadequate.
(This patent relates to strictly EPA & not in the EE or FA form, but the active molecule in the blood stream) Big...very Big.
8617594
Stable pharmaceutical composition and methods of using same
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.
We claim:
1. A method of reducing triglycerides comprising, identifying a group of subjects having a median triglyceride level of at least 500 mg/dl and orally administering daily to at least one subject in the group of subjects about 2500 mg to about 5000 mg of ethyl eicosapentaenoate, present in one or more capsules, wherein upon 12 weeks of said administering the at least one subject exhibits a reduction in triglycerides of at least about 15% without an increase of LDL-C of more than 5%.
2. The method of claim 1, wherein the group of subjects has a median fasting baseline LDL-C from about 50 mg/dl to about 300 mg/dl.
3. The method of claim 1, wherein the group of subjects has one or more of: a median baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a median baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a median baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a median baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.
4. The method of claim 1, wherein 12 weeks of said administering is effective to reduce triglycerides by at least about 30% without increasing LDL-C in the at least one subject.
5. The method of claim 1, wherein 12 weeks of said administering is effective to reduce apolipoprotein B in the at least one subject.
6. The method of claim 1, wherein 12 weeks of said administering is effective to reduce VLDL-C in the at least one subject.
7. The method of claim 1, wherein the group of subjects has a median fasting baseline triglyceride level of 500 mg/dl to 1500 mg/dl.
8. The method of claim 1, wherein the ethyl eicosapentaenoate is present in one or more dosage units.
9. The method of claim 8, wherein the dosage units are capsules.
10. A method of reducing triglycerides comprising, identifying a group of subjects having a median triglyceride level of at least 500 mg/dl and orally administering daily to at least one subject in the group 4 capsules, each capsule comprising about 900 mg to about 1 g of ethyl eicosapentaenoate, wherein upon 12 weeks of said administering the at least one subject exhibits a reduction in triglycerides by at least 15% without an increase of LDL-C of more than 5%.
11. The method of claim 10, wherein the group of subjects has a median fasting baseline LDL-C from about 50 mg/dl to about 300 mg/dl.
12. The method of claim 10, wherein the group of subjects has one or more of: a median baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a median baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a median baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a median baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.
13. The method of claim 10, wherein 12 weeks of said administering is effective to reduce triglycerides by at least about 30% without increasing LDL-C in the at least one subject.
14. The method of claim 10, wherein 12 weeks of said administering is effective to reduce apolipoprotein B in the at least one subject.
15. The method of claim 10, wherein 12 weeks of said administering is effective to reduce VLDL-C in the at least one subject.
16. The method of claim 10, wherein the group of subjects has a median fasting baseline triglyceride level of 500 mg/dl to 1500 mg/dl.
17. A method of reducing triglycerides comprising, identifying a group of subjects having a median triglyceride level of at least 500 mg/dl, orally administering daily to at least one subject in the group about 4 g of fatty acids, at least about 90% by weight of which are ethyl eicosapentaenoate, wherein upon 12 weeks of said administering the at least one subject exhibits a reduction in triglycerides by at least 15% without an increase of LDL-C of more than 5%.
18. The method of claim 17, wherein the group of subjects has a median fasting baseline LDL-C from about 50 mg/dl to about 300 mg/dl.
19. The method of claim 17, wherein the group of subjects has one or more of: a median baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a median baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a median baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a median baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.
20. The method of claim 17, wherein 12 weeks of said administering is effective to reduce triglycerides by at least about 30% without increasing LDL-C in the at least one subject.
21. The method of claim 17, wherein 12 weeks of said administering is effective to reduce apolipoprotein B in the at least one subject.
22. The method of claim 17, wherein 12 weeks of said administering is effective to reduce VLDL-C in the at least one subject.
23. The method of claim 17, wherein the group of subjects has a median fasting baseline triglyceride level of 500 mg/dl to 1500 mg/dl.
24. The method of claim 17, wherein the fatty acids other than ethyl eicosapentaenoate comprise at least one fatty acid selected from the group consisting of linolenic acid, ethyl linolenic acid, arachidonic acid, ethyl arachidonic acid, stearadonic acid, ethyl stearadonic acid, eicosatrienoic acid, ethyl eicosatrienoic acid, docosapentaenoic acid, and ethyl docosapentaenoic acid.
25. The method of claim 17, wherein the fatty acids are present in one or more dosage units.
26. The method of claim 25, wherein the dosage units are capsules.
8618166
What is claimed is:
1. A method of treating mixed dyslipidemia in a subject on statin therapy comprising, administering to the subject 4 capsules each comprising about 1 g of ethyl eicosapentaenoate daily effective to reduce fasting triglycerides and LDL-C relative to subjects having mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
2. The method of claim 1, wherein said administering step reduces fasting triglycerides by at least 10% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
3. The method of claim 1, wherein said administering step reduces fasting triglycerides by at least 15% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
4. The method of claim 1, wherein said administering step reduces fasting triglycerides by at least 20% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
5. The method of claim 1, wherein said administering step reduces fasting triglycerides by at least 25% and LDL-C by at least 5% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
6. The method of claim 1, wherein said administering step reduces fasting apolipoprotein B relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
7. The method of claim 1, wherein said administering step reduces fasting apolipoprotein B by at least 5% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
8. The method of claim 1, wherein said administering step reduces fasting VLDL-C relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
9. The method of claim 1, wherein said administering step reduces fasting VLDL-C by at least 15% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
10. The method of claim 1, wherein the statin is selected from lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin, fluvastatin, atorvastatin and simvastatin.
11. A method of treating mixed dyslipidemia in a subject on statin therapy comprising, administering to the subject 4 capsules each comprising about 900 mg of ethyl eicosapentaenoate daily effective to reduce fasting triglycerides and LDL-C relative to subjects having mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
12. A method of treating mixed dyslipidemia in a subject on statin therapy comprising, administering to the subject 4 capsules each comprising about 925 mg or about 950 mg of ethyl eicosapentaenoate daily effective to reduce fasting triglycerides and LDL-C relative to subjects having mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
13. A method of treating mixed dyslipidemia in a subject on statin therapy comprising, administering to the subject 4 capsules each comprising about 975 mg of ethyl eicosapentaenoate daily effective to reduce fasting triglycerides and LDL-C relative to subjects having mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
8623406
Stable pharmaceutical composition and methods of using same
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.
We claim:
1. A method of reducing triglycerides in a subject in need thereof who is on statin therapy comprising, administering to the subject 2500 mg to 5000 mg per day of ethyl eicosapentaenoate for a period effective to reduce triglycerides in the subject.
2. 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.
3. The method of claim 2 wherein the dosage units are capsules.
4. 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.
5. The method of claim 4 wherein the dosage units are capsules.
6. 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.
7. The method of claim 6 wherein the dosage units are capsules.
8. The method of claim 1 wherein the ethyl eicosapentaenoate is present in a pharmaceutical composition comprising other fatty acids or esters thereof and said ethyl eicosapentaenoate comprises at least about 90%, by weight, of the fatty acids present in the composition.
9. The method of claim 1 wherein the period is effective to reduce LDL-C in the subject.
10. The method of claim 1 wherein the subject has mixed dyslipidemia.
8642077
Stable pharmaceutical composition and methods of using same
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.
We claim:
1. A method of reducing triglycerides in a subject with mixed dyslipidemia on statin therapy comprising, administering to the subject a pharmaceutical composition comprising about 2500 mg to 5000 mg per day of ethyl eicosapentaenoate and not more than about 5%, by weight of all fatty acids, docosahexaenoic acid or its esters to effect a reduction in fasting triglyceride levels in the subject.
2. 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.
3. The method of claim 1 wherein the subject exhibits a reduction in fasting triglycerides of at least 15% compared to placebo control.
4. 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.
5. 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.
6. The method of claim 1 wherein the subject exhibits a reduction in fasting VLDL-C compared to placebo control.
7. The method of claim 1 wherein the subject exhibits a reduction in fasting VLDL-C of at least 5% compared to placebo control.
8. The method of claim 1 wherein the subject exhibits a reduction in hs-CRP compared to placebo control.
9. The method of claim 1 wherein the subject exhibits a reduction in non-HDL-C compared to placebo control.
10. The method of claim 1 wherein the subject exhibits a reduction in total cholesterol compared to placebo control.
11. The method of claim 1 wherein the subject exhibits a reduction in non-HDL-C, total cholesterol and VLDL-C compared to placebo control.
12. The method of claim 1 wherein the subject exhibits a reduction in oxidized LDL-C compared to placebo control.
13. The method of claim 1 wherein the subject exhibits a reduction in lipoprotein associated phospholipase A2 compared to placebo control.
14. 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.
15. The method of claim 14 wherein the dosage units are capsules.
16. 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.
17. The method of claim 16 wherein the ethyl eicosapentaenoate is administered to the subject in dosage units each comprising about 1 g of ethyl eicosapentaenoate.
18. The method of claim 17 wherein the dosage units are capsules.
19. The method of claim 1 wherein the ethyl eicosapentaenoate comprises at least about 90%, by weight, of all fatty acids.
8663662
Stable pharmaceutical composition and methods of using same
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.
We claim:
1. A method of lowering triglycerides in a subject with triglycerides of at least 500 mg/dl comprising, administering to the subject daily a pharmaceutical composition, present in one or more dosage units, comprising (a) an amount of eicosapentaenoic acid selected from the group consisting of about 1100 mg, about 1650 mg and about 2200 mg, and (b) not more than about 30%, by weight of total fatty acids, docosahexaenoic acid, for a period effective to reduce triglycerides in the subject without increasing LDL-C by more than 20%.
2. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to reduce triglycerides by at least 10% in the subject.
3. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to reduce triglycerides by at least 20% in the subject.
4. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to reduce non-HDL-C in the subject.
5. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to reduce non-HDL-C by 5% in the subject.
6. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to increase HDL-C in the subject.
7. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to increase HDL-C by 5% in the subject.
8. The method of claim 1 wherein the effective amount of eicosapentaenoic acid is about 1100 mg.
9. The method of claim 8 wherein administration of about 1100 mg of eicosapentaenoic acid per day results in an increase in plasma eicosapentaenoic acid levels of at least 200% in the subject.
10. The method of claim 1 wherein the effective amount of eicosapentaenoic acid is about 1650 mg.
11. The method of claim 10 wherein administration of about 1650 mg of eicosapentaenoic acid per day results in an increase in plasma eicosapentaenoic acid levels of at least 200% in the subject.
12. The method of claim 11 wherein the effective amount of eicosapentaenoic acid is about 2200 mg.
13. The method of claim 12 wherein administration of about 2200 mg of eicosapentaenoic acid per day results in an increase in plasma eicosapentaenoic acid levels of at least 400% in the subject.
14. The method of claim 13 wherein the pharmaceutical composition comprises not more than about 20%, by weight of total fatty acids, docosahexaenoic acid.
15. The method of claim 1 wherein the pharmaceutical composition comprises docosapentaenoic acid in an amount up to about 10% by weight of total fatty acids.
16. The method of claim 1 wherein the pharmaceutical composition comprises docosahexaenoic acid in an amount up to about 20% by weight of total fatty acids.
8669245
Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Abstract
In various embodiments, the present invention provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject in need thereof.
We claim:
1. A method of lowering triglycerides in a subject having mixed dyslipidemia on stable statin therapy having baseline fasting triglycerides of about 200 mg/dl to about 500 mg/dl, the method comprising orally administering to the subject daily a pharmaceutical composition comprising about 4 g of ethyl eicosapentaenoate and not more than about 4% docosahexaenoic acid or its esters, by weight of all fatty acids, for a period of at least about 4 weeks.
2. The method of claim 1, wherein the subject has coronary heart disease or a coronary heart disease risk equivalent.
3. The method of claim 2, wherein the subject has an LDL-C level of 40 mg/dl to 100 mg/dl prior to the administering step.
4. The method of claim 1, wherein LDL-C is reduced in the subject upon 4 weeks of said administering.
5. The method of claim 4, wherein the subject exhibits a reduction in one or more of: non-HDL-C, VLDL-C, Lp-PLA2, apolipoprotein B, total cholesterol, HDL-C or VLDL-TG.
6. The method of claim 1, wherein the subject exhibits a reduction in one or more of: non-HDL-C, VLDL-C, Lp-PLA2, apolipoprotein B, total cholesterol, HDL-C or VLDL-TG.
7. The method of claim 1, wherein the composition is present in one or more dosage units.
8. A method of lowering triglycerides in a subject on stable statin therapy having baseline fasting triglycerides of about 200 mg/dl to about 500 mg/dl and an LDL-C level of 40 mg/dl to 100 mg/dl, the method comprising orally administering to the subject daily a pharmaceutical composition, present more than one dosage unit, comprising about 4 g of ethyl eicosapentaenoate and not more than about 4% docosahexaenoic acid or its esters, by weight of all fatty acids, for a period of at least about 4 weeks.
9. The method of claim 8, wherein the subject has coronary heart disease or a coronary heart disease risk equivalent.
10. The method of claim 9, wherein the subject has an LDL-C level of 40 mg/dl to 100 mg/dl prior to the administering step.
11. The method of claim 10, wherein the subject has mixed dyslipidemia.
12. The method of claim 11, wherein LDL-C is reduced in the subject upon 4 weeks of said administering.
13. The method of claim 12, wherein the subject exhibits a reduction in one or more of: non-HDL-C, VLDL-C, Lp-PLA2, apolipoprotein B, total cholesterol, HDL-C or VLDL-TG.
8680144
Methods of treating mixed dyslipidemia
Abstract
The present disclosure relates to, inter alia, methods of treating mixed dyslipidemia with ethyl eicosapentaenoate.
We claim:
1. A method of treating hypertriglyceridemia in a subject in need thereof comprising, administering to the subject daily a statin and about 4 g of ethyl eicosapentaenoate effective to reduce fasting triglycerides and LDL-C relative to subjects having hypertriglyceridemia who are receiving a statin without said ethyl eicosapentaenoate.
2. The method of claim 1 wherein said administering step reduces fasting triglycerides by at least 10% relative to subjects with hypertriglyceridemia who are are receiving a statin without said ethyl eicosapentaenoate.
3. The method of claim 1 wherein said administering step reduces fasting triglycerides by at least 15% relative to subjects with hypertriglyceridemia who are receiving a statin without said ethyl eicosapentaenoate.
4. The method of claim 1 wherein said administering step reduces fasting triglycerides by at least 20% relative to subjects with hypertriglyceridemia who are receiving a statin without said ethyl eicosapentaenoate.
5. The method of claim 1 wherein said administering step reduces fasting triglycerides by at least 25% and LDL-C by at least 5% relative to subjects with hypertriglyceridemia who are receiving a statin without said ethyl eicosapentaenoate.
6. The method of claim 1 wherein said administering step reduces fasting apolipoprotein B relative to subjects with hypertriglyceridemia who are receiving a statin without said ethyl eicosapentaenoate.
7. The method of claim 1 wherein said administering step reduces fasting apolipoprotein B by at least 5% relative to subjects with hypertriglyceridemia who are receiving a statin without said ethyl eicosapentaenoate.
8. The method of claim 1 wherein said administering step reduces fasting VLDL-C relative to subjects with hypertriglyceridemia who are receiving a statin without said ethyl eicosapentaenoate.
9. The method of claim 1 wherein said administering step reduces fasting VLDL-C by at least 15% relative to subjects with hypertriglyceridemia who are receiving a statin without said ethyl eicosapentaenoate.
10. The method of claim 1 wherein the statin is selected from lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin, fluvastatin, atorvastatin and simvastatin.
11. The method of claim 1 wherein the ethyl eicosapentaenoate is administered to the subject in 1 to about 10 dosage units per day.
12. The method of claim 11 wherein the dosage units comprise capsules.
13. The method of claim 1 wherein the ethyl eicosapentaenoate is administered to the subject in 1 to about 4 dosage units per day.
14. The method of claim 13 wherein the dosage units comprise capsules.
8691871
8703185
Stable pharmaceutical composition and methods of using same
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.
We claim:
1. A method of treating hypertriglyceridemia in a subject in need thereof comprising, administering to the subject daily a statin and 2500 mg to about 5000 mg of ethyl eicosapentaenoate to reduce fasting triglycerides and LDL-C relative to subjects having hypertriglyceridemia who are receiving a statin without said ethyl eicosapentaenoate.
2. The method of claim 1 wherein said administering step reduces fasting triglycerides by at least 10% relative to subjects with hypertriglyceridemia who are receiving a statin without said ethyl eicosapentaenoate.
3. The method of claim 1 wherein said administering step reduces fasting triglycerides by at least 15% relative to subjects with hypertriglyceridemia who are receiving a statin without said ethyl eicosapentaenoate.
4. The method of claim 1 wherein said administering step reduces fasting triglycerides by at least 20% relative to subjects with hypertriglyceridemia who are receiving a statin without said ethyl eicosapentaenoate.
5. The method of claim 1 wherein said administering step reduces fasting triglycerides by at least 25% and LDL-C by at least 5% relative to subjects with hypertriglyceridemia who are receiving a statin without said ethyl eicosapentaenoate.
6. The method of claim 1 wherein said administering step reduces fasting apolipoprotein B relative to subjects with hypertriglyceridemia who are receiving a statin without said ethyl eicosapentaenoate.
7. The method of claim 1 wherein said administering step reduces fasting apolipoprotein B by at least 5% relative to subjects with hypertriglyceridemia who are receiving a statin without said ethyl eicosapentaenoate.
8. The method of claim 1 wherein said administering step reduces fasting VLDL-C relative to subjects with hypertriglyceridemia who are receiving a statin without said ethyl eicosapentaenoate.
9. The method of claim 1 wherein said administering step reduces fasting VLDL-C by at least 15% relative to subjects with hypertriglyceridemia who are receiving a statin without said ethyl eicosapentaenoate.
10. The method of claim 1 wherein the statin is selected from lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin, fluvastatin, atorvastatin and simvastatin.
11. The method of claim 1 wherein the ethyl eicosapentaenoate is present in one or more dosage units.
12. The method of claim 11 wherein the dosage units comprise capsules.
8709475
Stable pharmaceutical composition and methods of using same
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.
We claim:
1. A method of treating mixed dyslipidemia in a subject in need thereof comprising, administering to the subject daily a statin and 2500 mg to about 5000 mg of ethyl eicosapentaenoate to reduce fasting triglycerides and LDL-C relative to subjects having mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
2. The method of claim 1 wherein said administering step reduces fasting triglycerides by at least 10% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
3. The method of claim 1 wherein said administering step reduces fasting triglycerides by at least 15% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
4. The method of claim 1 wherein said administering step reduces fasting triglycerides by at least 20% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
5. The method of claim 1 wherein said administering step reduces fasting triglycerides by at least 25% and LDL-C by at least 5% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
6. The method of claim 1 wherein said administering step reduces fasting apolipoprotein B relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
7. The method of claim 1 wherein said administering step reduces fasting apolipoprotein B by at least 5% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
8. The method of claim 1 wherein said administering step reduces fasting VLDL-C relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
9. The method of claim 1 wherein said administering step reduces fasting VLDL-C by at least 15% relative to subjects with mixed dyslipidemia who are receiving a statin without said ethyl eicosapentaenoate.
10. The method of claim 1 wherein the statin is selected from lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin, fluvastatin, atorvastatin and simvastatin.
11. The method of claim 1 wherein the ethyl eicosapentaenoate is present in one or more dosage units.
12. The method of claim 11 wherein the dosage units comprise capsules.
8710041
8772309
AI
