Claims for Patent: 8,710,041

Summary for Patent: 8,710,041

Title:	Compositions and methods for lowering triglycerides 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.
Inventor(s):	Osterloh; Ian (Kent, GB), Wicker; Pierre (Mystic, CT), Braeckman; Rene (Richboro, PA), Soni; Paresh (Mystic, PA), Manku; Mehar (Birmingham, GB)
Assignee:	Amarin Pharmaceuticals Ireland Limited (Dublin, IE)
Application Number:	13/403,699
Patent Claims:	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 orally to the subject on stable statin therapy daily for a period of at least about 4 weeks a pharmaceutical composition comprising about 4 g of ethyl-EPA and not more than about 4% DHA or its esters, by weight of all fatty acids present. 2. The method of claim 1 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. 3. The method of claim 2 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. 4. The method of claim 3, wherein upon administering the composition to the subject daily for said period, the subject exhibits at least a 15% 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. 5. The method of claim 4, 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. 6. The method of claim 1, wherein the subject consumes a Western diet. 7. The method of claim 1, wherein the subject is at LDL-C goal at time of said initial administration of the composition. 8. 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. 9. 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, orally administering to the subject daily for a period of at least about 4 weeks a pharmaceutical composition comprising about 4 g of ethyl-EPA and not more than about 4% DHA or its esters, by weight of all fatty acids present. 10. The method of claim 9 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. 11. The method of claim 9 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. 12. The method of claim 9 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. 13. The method of claim 9 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. 14. 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 orally to the subject on statin therapy a pharmaceutical composition comprising about 4 g per day of ethyl-EPA and not more than about 4% DHA or its esters, by weight of all fatty acids present, for a period of at least about 4 weeks thereby to lower fasting triglycerides in the subject by at least 15% 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 results in a statistically significant 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.