COMPOSITIONS AND METHODS FOR LOWERING TRIGLYCERIDES IN A SUBJECT ON CONCOMITANT STATIN THERAPY
In various embodiments, the present invention provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject in need thereof.
1 . A method of lowering triglycerides in a subject on stable statin therapy having fasting triglycerides of about 200 mg/dl to less than 500 mg/dl comprising, administering to the subject on stable statin therapy from about 2 g to about 4 g per day of a pharmaceutical composition comprising at least 96% pure ethyl-EPA for a period effective to lower fasting triglycerides in the subject compared to a fasting triglyceride level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period.
2 . The method of claim 1 wherein said period is about 1 to about 12 weeks.
3 . The method of claim 2 wherein said period is about 1 to about 10 weeks.
4 . The method of claim 3 wherein said period is about 1 to about 5 weeks.
5 . The method of any one of claims 2 - 4 wherein the subject has serum LDL-C levels of about 40 mg/dl to about 115 mg/dl at a baseline prior to administration of the composition.
6 . The method of claim 5 wherein upon administering the composition to the subject daily for said period, the subject exhibits a reduction in fasting VLDL-C compared to a fasting VLDL-C level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period.
7 . The method of claim 6 , wherein upon administering the composition to the subject daily for said period, the subject exhibits at least a 20% reduction in fasting triglycerides compared to a fasting triglyceride level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period.
8 . The method of claim 7 , wherein upon administering the composition to the subject daily for said period, the subject exhibits at least a 25% reduction in fasting triglycerides compared to a fasting triglyceride level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period.
9 . The method of claim 8 , wherein upon administering the composition to the subject daily for said period, the subject exhibits a reduction in fasting LDL-C compared to a fasting LDL-C level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period.
10 . The method of claim 1 , wherein the subject consumes a Western diet.
11 . The method of claim 1 , wherein the subject is at LDL-C goal at time of said initial administration of the composition.
12 . The method of claim 1 , wherein the subject has a fasting LDL-C level of about 40 mg/dl to about 100 mg/dl and a fasting triglyceride level of about 200 mg/dl to about 500 mg/dl immediately prior to initial administration of the composition.
13 . A method of lowering triglycerides in a subject on stable statin therapy having fasting triglycerides of about 200 mg/dl to less than 500 mg/dl and a fasting LDL-C level of about 40 mg/dl to about 100 mg/dl comprising, administering to the subject 2 g to about 4 g per day of a pharmaceutical composition comprising at least 96% pure ethyl-EPA for a period effective to lower fasting triglycerides in the subject.
14 . The method of claim 13 wherein upon administering the composition to the subject for said period, the subject exhibits a reduction in fasting non-LDL compared to a fasting non-LDL level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period.
15 . The method of claim 13 wherein upon administering the composition to the subject daily for said period, the subject exhibits a reduction in fasting VLDL-C compared to a fasting VLDL-C level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period.
16 . The method of claim 13 wherein upon administering the composition to the subject daily for said period, the subject exhibits a reduction in fasting non-HDL-C compared to a fasting non-HDL-C level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period.
17 . The method of claim 13 wherein upon administering the composition to the subject daily for said period, the subject exhibits a reduction in fasting total cholesterol compared to a fasting total cholesterol level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period.
18 . The method of claim 13 where said period is about 1 to about 12 weeks
19 . The method of claim 13 where said period is about 1 to about 10 weeks.
20 . The method of claim 13 wherein said period is about 1 to about 5 weeks.
21 . A method of lowering triglycerides in a subject on stable statin therapy having fasting triglycerides of about 200 mg/dl to less than 500 mg/dl comprising, administering to the subject on statin therapy from 2 g to 4 g per day of a pharmaceutical composition comprising at least 96% pure ethyl-EPA for a period of about 1 to about 12 weeks thereby to lower fasting triglycerides in the subject by least 25% compared to a fasting triglyceride level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period, and wherein administration of the composition does not result in a statistically significant increase in fasting LDL-C compared to a fasting LDL-C level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period.