Methods of reducing triglycerides and LDL-C
View Patent ↗The present disclosure relates to, inter alia, methods of treating mixed dyslipidemia with ethyl eicosapentaenoate.
1. A method of reducing triglycerides and LDL-C in a subject on stable rosuvastatin therapy having baseline fasting triglycerides of 200 mg/dl to about 500 mg/dl comprising, administering daily to the subject for a period of at least about 12 weeks about 4 g of fatty acids composed of at least about 96% ethyl eicosapentaenoate, by weight of all fatty acids, and not more than about 3% docosahexaenoic acid or its esters by weight of all fatty acids, to effect a reduction in triglycerides and LDL-C in the subject.
2. The method of claim 1 , wherein the subject has a baseline LDL-C level of about 40 mg/dl to about 115 mg/dl.
3. The method of claim 1 , comprising administering said fatty acids to the subject daily for the period to effect a reduction in LDL-C of at least about 10% compared to placebo control.
4. The method of claim 3 , comprising administering said fatty acids to the subject daily for the period to effect a reduction in triglycerides of at least about 15% compared to placebo control.
5. The method of claim 1 , wherein the fatty acids are administered in 4 capsules, each capsule comprising about 900 mg to about 1.2 g of ethyl eicosapentaenoate.
6. The method of claim 1 , wherein the rosuvastatin and at least a portion of the fatty acids are co-administered in different dosage units.
7. A method of reducing triglycerides and LDL-C in a subject on stable rosuvastatin therapy having baseline fasting triglycerides of about 200 mg/dl to about 500 mg/dl comprising, administering to the subject daily for a period of at least about 12 weeks 4 capsules, each capsule comprising about 900 mg to about 1.2 g of ethyl eicosapentaenoate and not more than about 3% docosahexaenoic acid or its esters, by weight of all fatty acids present, to effect a reduction in triglycerides and LDL-C in the subject compared to placebo control.
8. The method of claim 7 , comprising administering said capsules to the subject daily for the period to effect a reduction in LDL-C of at least about 10% compared to placebo control.
9. The method of claim 8 , comprising administering said capsules to the subject daily for the period to effect a reduction in triglycerides of at least about 15% compared to placebo control.
10. The method of claim 7 , wherein each of said 4 capsules comprises about 1 to about 1.1 g of the ethyl eicosapentaenoate.
11. The method of claim 7 , wherein the rosuvastatin and ethyl eicosapentaenoate are co-administered in different capsules.