New Patent app
Compositions and methods for lowering triglycerides (type 2 diabetes mellitus and fasting triglycerides of about 200 mg/dl to less than 500 mg/dl)
Claims
What is claimed is:
1. A method of lowering triglycerides in a subject on stable statin therapy having type 2 diabetes mellitus and fasting triglycerides of about 200 mg/dl to less than 500 mg/dl comprising administering to the subject a composition comprising about 4 g per day of ethyl eicosapentaenoate for a period effective to reduce fasting triglycerides in the subject compared to a fasting triglyceride level in a subject having type 2 diabetes mellitus who is maintained on stable statin therapy without concomitant ethyl eicosapentaenoate therapy for said period.
2. The method of claim 1, wherein the composition is administered to the subject 1 to 4 times per day.
3. The method of claim 2, wherein the composition is present in one or more capsules.
4. The method of claim 1, wherein the ethyl eicosapentaenoate represents at least about 80%, by weight, of all fatty acids present in the composition.
5. The method of claim 1, wherein the composition contains not more than about 10% by weight of docosahexaenoic acid or derivatives thereof.
6. The method of claim 1, wherein the step of administering is further effective to reduce an LDL-C level in the subject compared to an LDL-C level in the subject having type 2 diabetes mellitus who is maintained on stable statin therapy without concomitant ethyl eicosapentaenoate therapy for said period.
7. The method of claim 1, wherein the step of administering is further effective to reduce a non-HDL-C level in the subject compared to a non-HDL-C level in the subject having type 2 diabetes mellitus who is maintained on stable statin therapy without concomitant ethyl eicosapentaenoate therapy for said period.
8. The method of claim 1, wherein the step of administering is further effective to reduce an ApoB level in the subject compared to an ApoB level in the subject having type 2 diabetes mellitus who is maintained on stable statin therapy without concomitant ethyl eicosapentaenoate therapy for said period.
9. The method of claim 1, wherein the period is about 1 week to about 12 weeks.
10. The method of claim 1, wherein the period is about 12 weeks.
11. The method of claim 1, wherein the step of administering is further effective to reduce an LDL-C level, a non-HDL-C level, and an ApoB level in the subject compared to an LDL-C level, a non-HDL-C level, and an ApoB level, respectively, in the subject having type 2 diabetes mellitus who is maintained on stable statin therapy without concomitant ethyl eicosapentaenoate therapy for said period.
12. The method of claim 11, wherein the step of administering is further effective to reduce the triglycerides by at least about 20%, the LDL-C level by at least about 5%, the non-HDL-C level by at least about 10%, and the ApoB level by at least about 5% in the subject compared to the triglyceride level, the LDL-C level, the non-HDL-C level, and the ApoB level, respectively, in the subject having type 2 diabetes mellitus who is maintained on stable statin therapy without concomitant ethyl eicosapentaenoate therapy for said period.
13. The method of claim 1 wherein the subject has a baseline fasting LDL-C level of 40 mg/dl to 100 mg/dl and a fasting triglyceride level of 200 mg/dl to 500 mg/dl immediately prior to initial administration of the pharmaceutical composition.
14. The method of claim 1, wherein the step of administering is further effective to increase LDL particle size in the subject compared to an LDL particle size in the subject having type 2 diabetes mellitus who is maintained on stable statin therapy without concomitant ethyl eicosapentaenoate therapy for said period.
15. The method of claim 1, wherein the step of administering is further effective to reduce an LDL particle number by at least about 5% in the subject compared to an LDL particle number in the subject having type 2 diabetes mellitus who is maintained on stable statin therapy without concomitant ethyl eicosapentaenoate therapy for said period
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