METHODS OF REDUCING LDL-P
In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of reducing LDL-P comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
1 . A method of reducing LDL-P in a subject in need thereof, comprising:
identifying the subject as having a baseline LDL-P level of at least 1,000 nmol/L; and
thereafter administering to the subject about 1 g to about 4 g of ethyl eicosapentaenoate per day.
2 . The method of claim 1 , further comprising a step of measuring a baseline lipid profile in the subject prior to administering the ethyl eicosapentaenoate to said subject.
3 . The method of claim 2 , wherein the subject is identified as having:
a baseline LDL-P of at least 1,000 nmol/L and less than 1,300 nmol/L;
a baseline LDL-P of at least 1,300 nmol/L and optionally less than 1,600 nmol/L;
a baseline LDL-P of at least 1,600 nmol/L and optionally less than 2,000 nmol/L; or
a baseline LDL-P of at least 2,000 nmol/L.
4 . The method of claim 1 , wherein after administration of the ethyl eicosapentaenoate, the subject experiences a reduction in LDL-P of at least about 5% (actual % change or median % change) compared to baseline.
5 . The method of claim 1 , wherein the subject is associated a first MESA percentile group before administration of the ethyl eicosapentaenoate, and wherein the subject is associated with a second, lower MESA percentile group after administration.
6 . The method of claim 5 , wherein:
the first MESA percentile group is a >95th percentile group, and the second MESA percentile group is selected from the group consisting of: an 80th to 95th percentile group, a 50th to 80th percentile group, a 20th to 50th percentile group, or a <20th percentile group;
the first MESA percentile group is an 80th to 95th percentile group, and the second MESA percentile group is selected from the group consisting of: a 50th to 80th percentile group, a 20th to 50th percentile group, or a <20th percentile group;
the first MESA percentile group is a 50th to 80th percentile group, and the second MESA percentile group is selected from the group consisting of: a 20th to 50th percentile group, or a <20th percentile group; or
the first MESA percentile group is a 20th to 50th percentile group, and the second MESA percentile group is a <20th percentile group.
7 . The method of claim 6 , wherein the subject is administered 2 g to about 4 g of ethyl eicosapentaenoate per day.
8 . The method of claim 7 , wherein the subject is administered about 2 g or about 4 g of ethyl eicosapentaenoic acid per day.
9 . The method of claim 8 , wherein the ethyl eicosapentaenoate is administered to the subject 1 to 4 times per day.
10 . The method of claim 9 , wherein the ethyl eicosapentaenoate comprises at least about 90%, by weight, of all fatty acids administered to the subject.
11 . The method of claim 10 , wherein docosahexaenoic acid and its derivatives comprise no more than about 10%, by weight, of all fatty acids administered to the subject.
12 . The method of claim 11 , wherein the ethyl eicosapentaenoate is present in a capsule.
13 . The method of claim 12 , wherein the subject is not on concomitant lipid-altering therapy.
14 . The method of claim 13 , wherein the subject is diabetic.
15 . The method of claim 14 , wherein the subject is not on concomitant lipid-altering therapy.
16 . The method of claim 15 , wherein the ethyl eicosapentaenoate is packaged in blister packages of about 1 to less than about 20 capsules per sheet.