Methods of treating mixed dyslipidemia
The present disclosure relates to, inter alia, methods of treating mixed dyslipidemia with ethyl eicosapentaenoate.
1. A pharmaceutical composition, comprising a PPAR agonist dispersed in eicosapentaenoic acid, wherein:
the pharmaceutical composition is present in a capsule;
the pharmaceutical composition comprises substantially no docosahexaenoic acid (DHA); and
the pharmaceutical composition further comprises at least one fatty acid other than EPA and/or DHA, which is selected from the group consisting of ethyl octadecatetraenoate (ODTA-E), ethyl nonaecapentaenoate (NDPA-E), ethyl eicosatetraenoate (ETA-E), and ethyl heneicosapentaenoate (HPA-E).
2. The pharmaceutical composition of claim 1 , wherein the eicosapentaenoic acid comprises at least about 80 wt. % of all omega-3 fatty acids in the pharmaceutical composition.
3. The pharmaceutical composition of claim 1 , wherein the eicosapentaenoic acid comprises at least about 96 wt. % of all omega-3 fatty acids in the pharmaceutical composition.
4. The pharmaceutical composition of claim 1 , wherein about 1 g of the pharmaceutical composition is present in each of 4 capsules.
5. The pharmaceutical composition of claim 1 , wherein the eicosapentaenoic acid is ethyl eicosapentaenoate.
6. The pharmaceutical composition of claim 1 , wherein the PPAR agonist is selected from the group consisting of fenofibrate, bezafibrate, ciprofibrate, clofibrate, gemfibrozil, CER-002, rosiglitazone, GW501516, RWJ 800025, KD-3010, and combinations thereof.
7. The pharmaceutical composition of claim 1 , wherein the PPAR agonist is present in an amount of about 0.5 mg to about 120 mg.
8. The pharmaceutical composition of claim 1 , which comprises no DHA.
9. The pharmaceutical composition of claim 1 , which comprises not more than about 0.06% by weight of DHA, relative to a weight of total fatty acids present in the composition.
10. The pharmaceutical composition of claim 1 , which comprises not more than about 0.04% by weight of DHA, relative to a weight of total fatty acids present in the composition.
11. The pharmaceutical composition of claim 1 , wherein the fatty acid other than EPA and/or DHA further comprises arachidonic acid (AA) or a derivative thereof.
12. The pharmaceutical composition of claim 11 , wherein the AA or a derivative thereof is ethyl arachidonate (AA-E).
13. The pharmaceutical composition of claim 12 , wherein ODTA-E is present in an amount of about 0.2% to about 0.5% by weight, NDPA-E is present in an amount of about 0.05% to about 0.25% by weight, AA-E is present in an amount of about 0.2% to about 0.45% by weight, ETA-E is present in an amount of about 0.3% to about 0.5% by weight, and HPA-E is present in an amount of about 0.05% to about 0.32%, each relative to a weight of total fatty acids present in the composition.
14. The pharmaceutical composition of claim 12 , wherein ODTA-E is present in an amount of about 0.22% to about 0.4% by weight, NDPA-E is present in an amount of about 0.075% to about 0.20% by weight, AA-E is present in an amount of about 0.25% to about 0.40% by weight, ETA-E is present in an amount of about 0.3% to about 0.4% by weight, and HPA-E is present in an amount of about 0.075% to about 0.25%, each relative to a weight of total fatty acids present in the composition.
15. The pharmaceutical composition of claim 12 , wherein ODTA-E is present in an amount of about 0.25% to about 0.38% by weight, NDPA-E is present in an amount of about 0.10% to about 0.15% by weight, AA-E is present in an amount of about 0.25% to about 0.35% by weight, ETA-E is present in an amount of about 0.31% to about 0.38% by weight, and HPA-E is present in an amount of about 0.08% to about 0.20%, each relative to a weight of total fatty acids present in the composition.
16. The pharmaceutical composition of claim 1 , which further comprises an antioxidant.
17. The pharmaceutical composition of claim 16 , wherein the antioxidant is at least one selected from the group consisting of tocopherol, lecithin, citric acid, and ascorbic acid.
18. The pharmaceutical composition of claim 16 , wherein the antioxidant is present in an amount of not more of about 0.01% to about 0.1% by weight, relative to a total weight of the composition.
19. The pharmaceutical composition of claim 16 , wherein the antioxidant is present in an amount of about 0.025% to about 0.05% by weight, relative to a total weight of the composition.