CO-ADMINISTRATION OF ATORVASTATIN AND ETHYL EICOSAPENTAENOIC ACID OR A DERIVATIVE THEREOF

1 . A pharmaceutical composition comprising atorvastatin, the composition providing a mean steady state plasma C max , a mean steady state plasma AUC 0-24 , and/or a mean steady state plasma T max of atorvastatin of about 70% to about 135%, when co-administered with about 2 g or about 4 g per day of ethyl eicosapentaenoate, of a mean steady state plasma C max , a mean steady state plasma AUC 0-24 , and/or a mean steady state plasma T max of atorvastatin provided by a second pharmaceutical composition comprising atorvastatin administered without the ethyl eicosapentaenoate.

2 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition provides a mean steady state plasma C max , a mean steady state plasma AUC 0-24 , and/or a mean steady state plasma T max of atorvastatin of about 80% to about 125% of a mean steady state plasma C max , a mean steady state plasma AUC 0-24 , and/or a mean steady state plasma T max of atorvastatin provided by the second pharmaceutical composition.

3 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition provides a mean steady state plasma C max , a mean steady state plasma AUC 0-24 , and/or a mean steady state plasma T max of atorvastatin of about 70% to about 135%, when co-administered with about 4 g per day of ethyl eicosapentaenoate, compared to a mean steady state plasma C max , a mean steady state plasma AUC 0-24 , and/or a mean steady state plasma T max of atorvastatin provided by the second pharmaceutical composition.

4 . The pharmaceutical composition of claim 3 , wherein the pharmaceutical composition provides a mean steady state AUC 0-24 of about 80% to about 125% of the second pharmaceutical composition.

5 . The pharmaceutical composition of claim 4 , wherein the pharmaceutical composition provides a mean steady state AUC 0-24 of about 168.6 ng·hr/mL.

6 . The pharmaceutical composition of claim 5 , wherein the pharmaceutical composition provides a mean steady state C max of about 70% to about 135%, when co-administered with about 4 g per day of ethyl eicosapentaenoate, of a mean steady state plasma C max provided by the second pharmaceutical composition.

7 . The pharmaceutical composition of claim 6 , wherein the pharmaceutical composition provides a mean steady state C max of about 80% to about 125% of the second pharmaceutical composition.

8 . The pharmaceutical composition of claim 7 , wherein the pharmaceutical composition provides a mean steady state C max of about 53.2 ng/mL.

9 . The pharmaceutical composition of claim 8 , wherein the atorvastatin is present in an amount of about 1 mg to about 80 mg.

10 . The pharmaceutical composition of claim 9 , wherein the ethyl eicosapentaenoate is in a capsule.

11 . The pharmaceutical composition of claim 10 , wherein the capsule comprises at least about 80%, by weight of all fatty acids (and/or derivatives thereof) present, ethyl eicosapentaenoate.

12 . The pharmaceutical composition of claim 11 , wherein the capsule comprises at least about 90%, by weight of all fatty acids (and/or derivatives thereof) present, ethyl eicosapentaenoate.

13 . The pharmaceutical composition of claim 12 , wherein the capsule comprises at least about 95%, by weight of all fatty acids (and/or derivatives thereof) present, ethyl eicosapentaenoate.

14 . The pharmaceutical composition of claim 13 , wherein the capsule comprises at least about 96%, by weight of all fatty acids (and/or derivatives thereof) present, ethyl eicosapentaenoate.

15 . The pharmaceutical composition of claim 14 , wherein the capsule comprises no more than about 20%, by weight of all fatty acids (and/or derivatives thereof) present, docosahexaenoic acid or esters thereof.

16 . The pharmaceutical composition of claim 15 , wherein the capsule comprises no more than about 10%, by weight of all fatty acids (and/or derivatives thereof) present, docosahexaenoic acid or esters thereof.

17 . The pharmaceutical composition of claim 16 , wherein the capsule comprises no more than about 5%, by weight of all fatty acids (and/or derivatives thereof) present, docosahexaenoic acid or esters thereof.

18 . The pharmaceutical composition of claim 17 , wherein the capsule comprises no more than about 3%, by weight of all fatty acids (and/or derivatives thereof) present, docosahexaenoic acid or esters thereof.

19 . The pharmaceutical composition of claim 18 , wherein the capsule comprises substantially no docosahexaenoic acid or esters thereof.

20 . The pharmaceutical composition of claim 19 , wherein the capsule comprises no docosahexaenoic acid or esters thereof.

21 . A pharmaceutical composition comprising at least about 80%, by weight of all fatty acids (and/or derivatives thereof) present, ethyl eicosapentaenoate, wherein the pharmaceutical composition does not significantly alter a blood plasma C max , a blood plasma AUC 0-24 , and/or a blood plasma T max of atorvastatin.

22 . The pharmaceutical composition of claim 21 , wherein the pharmaceutical composition is administered at a daily dose of about 2 g or about 4 g per day.

23 . The pharmaceutical composition of claim 21 or claim 22 , wherein the atorvastatin is administered at a daily dose of about 80 mg per day.

24 . The pharmaceutical composition of claim 23 , wherein the blood plasma C max , the blood plasma AUC 0-24 , and/or the blood plasma T max is a steady state blood plasma C max , a steady state blood plasma AUC 0-24 , and/or a steady state blood plasma T max .

25 . The pharmaceutical composition of claim 24 , wherein the pharmaceutical composition alters the blood plasma C max , the blood plasma AUC 0-24 , and/or the blood plasma T max of atorvastatin by no more than about 30% compared to administration of atorvastatin without the pharmaceutical composition.

26 . The pharmaceutical composition of claim 25 , wherein the pharmaceutical composition alters the blood plasma C max , the blood plasma AUC 0-24 , and/or the blood plasma T max of atorvastatin by no more than about 25% compared to administration of atorvastatin without the pharmaceutical composition.

27 . The pharmaceutical composition of claim 26 , wherein the pharmaceutical composition alters the blood plasma C max , the blood plasma AUC 0-24 , and/or the blood plasma T max of atorvastatin by no more than about 20% compared to administration of atorvastatin without the pharmaceutical composition.

28 . The pharmaceutical composition of claim 27 , wherein the pharmaceutical composition alters the blood plasma C max , the blood plasma AUC 0-24 , and/or the blood plasma T max of atorvastatin by no more than about 15% compared to administration of atorvastatin without the pharmaceutical composition.

29 . The pharmaceutical composition of claim 28 , wherein the pharmaceutical composition alters the blood plasma C max and the blood plasma AUC 0-24 of atorvastatin by no more than about 35%, by no more than about 30%, by no more than about 25%, by no more than about 20%, or by no more than about 15% compared to administration of atorvastatin without the pharmaceutical composition.

30 . The pharmaceutical composition of claim 28 , wherein the pharmaceutical composition alters the blood plasma T max and the blood plasma AUC 0-24 of atorvastatin by no more than about 35%, by no more than about 30%, by no more than about 25%, by no more than about 20%, or by no more than about 15% compared to administration of atorvastatin without the pharmaceutical composition.

31 . The pharmaceutical composition of claim 28 , wherein the pharmaceutical composition alters the blood plasma C max and the blood plasma T max of atorvastatin by no more than about 35%, by no more than about 30%, by no more than about 25%, by no more than about 20%, or by no more than about 15% compared to administration of atorvastatin without the pharmaceutical composition.

32 . The pharmaceutical composition of claim 28 , wherein the pharmaceutical composition alters the blood plasma C max , the blood plasma AUC 0-24 , and the blood plasma T max of atorvastatin by no more than about 35%, by no more than about 30%, by no more than about 25%, by no more than about 20%, or by no more than about 15% compared to administration of atorvastatin without the pharmaceutical composition.

33 . A method of reducing triglycerides in a subject on atorvastatin therapy, the method comprising administering to the subject a pharmaceutical composition comprising at least about 80%, by weight of all fatty acids (and/or derivatives thereof) present, ethyl eicosapentaenoate.

34 . A method of reducing triglycerides in a subject on atorvastatin therapy, the method comprising administering to the subject about 1 to about 4 capsules per day, each capsule comprising about 1 g of ethyl eicosapentaenoate.

35 . The method of claim 33 , wherein a C max , an AUC 0-24 , and/or a T max of atorvastatin is not significantly altered compared to a second subject or a second subject group who has received the atorvastatin but not the ethyl eicosapentaenoate.

36 . The method of claim 35 , wherein any one or more of the C max , the AUC 0-24 , and/or the T max of atorvastatin is altered by no more than about 35% compared to the second subject or second subject group.

37 . The method of claim 36 , wherein any one or more of the C max , the AUC 0-24 , and/or the T max of atorvastatin is altered by no more than about 30% compared to the second subject or second subject group.

38 . The method of claim 37 , wherein any one or more of the C max , the AUC 0-24 , and/or the T max of atorvastatin is altered by no more than about 25% compared to the second subject or second subject group.

39 . The method of claim 38 , wherein any one or more of the C max , the AUC 0-24 , and/or the T max of atorvastatin is altered by no more than about 20% compared to the second subject or second subject group.

40 . The method of claim 39 , wherein any one or more of the C max , the AUC 0-24 , and/or the T max of atorvastatin is altered by no more than about 15% compared to the second subject or second subject group.

41 . The method of claim 40 , wherein the subject has a fasting baseline triglyceride level of about 200 mg/dl to 499 mg/dl.

42 . The method of claim 41 , wherein the second subject or second subject group has a fasting baseline triglyceride level or a mean or median fasting baseline triglyceride level of about 200 mg/dl to 499 mg/dl.

43 . The method of claim 40 , wherein the subject has a fasting baseline triglyceride level of at least 500 mg/dl.

44 . The method of claim 43 , wherein the second subject or second subject group has a fasting baseline triglyceride level or a mean or median fasting baseline triglyceride level of at least 500 mg/dl.

45 . The method of claim 44 , wherein triglycerides are reduced in the subject with no increase in an LDL-C level in the subject.

46 . The method of claim 45 , wherein the reduction in triglycerides and the no increase in LDL-C level is in comparison to baseline or to a second subject or subject group that has received atorvastatin but not the ethyl eicosapentaenoate.

47 . The method of claim 44 , wherein the capsules comprise at least about 80%, by weight of all fatty acids (and/or derivatives thereof) present, ethyl eicosapentaenoate.

48 . The method of claim 47 , wherein ethyl eicosapentaenoate represents at least about 90%, by weight of all fatty acids (and/or derivatives thereof) present.

49 . The method of claim 48 , wherein ethyl eicosapentaenoate represents at least about 95%, by weight of all fatty acids (and/or derivatives thereof) present.

50 . The method of claim 49 , wherein ethyl eicosapentaenoate represents at least about 96%, by weight of all fatty acids (and/or derivatives thereof) present.

51 . The method of claim 34 , wherein docosahexaenoic acid and its esters represent no more than about 20%, by weight of all fatty acids (and/or derivatives thereof) present in the pharmaceutical composition or capsule.

52 . The method of claim 51 , wherein docosahexaenoic acid and its esters represent no more than about 10%, by weight of all fatty acids (and/or derivatives thereof) present in the pharmaceutical composition or capsule.

53 . The method of claim 52 , wherein docosahexaenoic acid and its esters represent no more than about 5%, by weight of all fatty acids (and/or derivatives thereof) present in the pharmaceutical composition or capsule.

54 . The method of claim 53 , wherein docosahexaenoic acid and its esters represent no more than about 3%, by weight of all fatty acids (and/or derivatives thereof) present in the pharmaceutical composition or capsule.

55 . A method of reducing triglycerides in a subject in need thereof, the method comprising, co-administering atorvastatin and about 2 g or about 4 g per day of ethyl eicosapentaenoate, wherein said co-administration provides a steady state plasma C max , a steady state plasma AUC 0-24 , and/or a steady state plasma T max of atorvastatin of about 70% to about 135% of a mean steady state plasma C max , a mean steady state plasma AUC 0-24 , and/or a mean steady state plasma T max of atorvastatin in subjects receiving said atorvastatin daily without the ethyl eicosapentaenoate.