COMPOSITIONS AND METHODS FOR TREATING AND/OR PREVENTING CARDIOVASCULAR DISEASE
In various embodiments, the present invention provides pharmaceutical compositions comprising fatty acids and methods for treating subjects using same.
1 . A pharmaceutical composition comprising about 1 g of ethyl eicosapentaenoate, the pharmaceutical composition providing a mean plasma C max of about 154.9+/−49.4 μg/mL, a mean plasma AUC 0-24h of about 2907+/−1160 μg·h/mL, a median plasma T max of about 5 hours, and a mean plasma T 1/2 of about 75.1+/−46.5 hours of ethyl eicosapentaenoate when administered orally twice per day to a human subject.
2 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further provides a mean plasma C min of about 101.0+/−50.4 μg/mL of ethyl eicosapentaenoate.
3 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further provides a mean plasma CL/F of about 776.4+/−256.9 mL/h of ethyl eicosapentaenoate.
4 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further provides a mean plasma V z /F of about 79.8+/−62.6 L of ethyl eicosapentaenoate.
5 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further provides a mean RBC C max of about 42.3+/−14.0 μg/mL, a mean RBC AUC 0-24h of about 801.5+/−268.5 μg·h/mL, a median RBC T max of about 12 hours, and a mean RBC T 1/2 of about 683.8 hours of ethyl eicosapentaenoate.
6 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further provides a mean RBC C min of about 31.2+/−12.2 μg/mL of ethyl eicosapentaenoate.
7 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further provides a mean plasma C max of about 0.66+/−0.34 μg/mL, a mean plasma AUC 0-24h of about 6.9+/−3.1 μg·h/mL, a median plasma T max of about 5 hours, and a mean plasma T 1/2 of about 80.8+/−37.5 hours of unesterified eicosapentaenoic acid when administered orally twice per day to a human subject.
8 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further provides a mean plasma C min of about 0.41+/−0.28 μg/mL of unesterified eicosapentaenoic acid.
9 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further provides a mean plasma CL/F of about 364,513+/−214,003 mL/h of unesterified eicosapentaenoic acid.
10 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further provides a mean plasma V z /F of about 33,164+/−8,068 L of unesterified eicosapentaenoic acid.
11 . A pharmaceutical composition comprising about 2 g of ethyl eicosapentaenoate, the pharmaceutical composition providing a mean plasma C max of about 347.2+/−112.5 μg/mL, a mean plasma AUC 0-24h of about 6519+/−1963 μg·h/mL, a median plasma T max of 5 hours, and a mean plasma T 1/2 of about 89.3+/−42.0 hours of ethyl eicosapentaenoate when administered orally twice per day to a human subject.
12 . The pharmaceutical composition of claim 11 , wherein the pharmaceutical composition further provides a mean plasma C min of about 101.0+/−50.4 μg/mL of ethyl eicosapentaenoate.
13 . The pharmaceutical composition of claim 11 , wherein the pharmaceutical composition further provides a mean plasma CL/F of about 683.7+/−280.6 mL/h of ethyl eicosapentaenoate.
14 . The pharmaceutical composition of claim 11 , wherein the pharmaceutical composition further provides a mean plasma V z /F of about 88.4+/−55.2 L of ethyl eicosapentaenoate.
15 . The pharmaceutical composition of claim 11 , wherein the pharmaceutical composition further provides a mean RBC C max of about 76.7+/−25.2 μg/mL, a mean RBC AUC 0-24h of about 1472+/−469.5 μg·h/mL, a median RBC T max of about 8 hours, and a mean RBC T 1/2 of about 371.4+/−311.5 hours of ethyl eicosapentaenoate.
16 . The pharmaceutical composition of any one of claim 11 , wherein the pharmaceutical composition further provides a mean RBC C min of 64.1+/−21.8 μg/mL of ethyl eicosapentaenoate.
17 . The pharmaceutical composition of claim 11 , wherein the pharmaceutical composition further provides a mean plasma C max of about 1.4+/−0.41 μg/mL, a mean plasma AUC 0-24h of about 18.4+/−4.6 μg·h/mL, a median plasma T max of about 5 hours, and a mean plasma T 1/2 of about 97.2+/−36.5 hours of unesterified eicosapentaenoic acid.
18 . The pharmaceutical composition of claim 11 , wherein the pharmaceutical composition further provides a mean plasma C min of about 1.06+/−0.56 μg/mL of unesterified eicosapentaenoic acid.
19 . The pharmaceutical composition of claim 11 , wherein the pharmaceutical composition further provides a mean plasma CL/F of about 234,329+/−81,639 mL/h of unesterified eicosapentaenoic acid.
20 . The pharmaceutical composition of claim 11 , wherein the pharmaceutical composition further provides a mean plasma V z /F of about 28,200+/−10,929 L of unesterified eicosapentaenoic acid.
21 . The pharmaceutical composition of any claim 11 , wherein the pharmaceutical composition is administered in unit dose form, wherein each unit dose includes about 1 g of ethyl eicosapentaenoate.