METHODS OF TREATING HYPERTRIGLYCERIDEMIA
In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
1 . A method of reducing a C-reactive protein level in a subject having metabolic syndrome and fasting triglycerides of at least 500 mg/dL, the method comprising:
identifying the subject as having metabolic syndrome;
identifying the subject as having fasting triglycerides of at least 500 mg/dL; and
orally administering to the subject about 4 g per day of ethyl eicosapentaenoate for a period of time effective to reduce a C-reactive protein (“CRP”) level in the subject.
2 . The method of claim 1 , wherein the reduction in CRP level is at least about 20%, about 27%, about 28%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, about 78%, at least about 80%, at least about 90%, or greater than about 90%.
3 . The method of claim 2 , wherein the reduction in CRP is compared to a second subject having metabolic syndrome and fasting triglycerides of at least 500 mg/dL who has not received the ethyl eicosapentaenoate.
4 . The method of claim 1 , wherein the ethyl eicosapentaenoate comprises at least about 90%, at least about 95%, or at least about 96% of the fatty acids present.
5 . The method of claim 1 , wherein the subject is not administered DHA or an ester thereof.
6 . The method of claim 1 , wherein the period of time is at least about 12 weeks
7 . The method of claim 1 , wherein the step of orally administering the ethyl eicosapentaenoate further reduces one or more of:
a triglyceride level associated with the subject;
a non-HDL-C level associated with the subject; and
an apolipoprotein B level associated with the subject.
8 . The method of claim 1 , wherein the subject has a fasting baseline triglyceride level of 500 mg/dL to 1500 mg/dL.
9 . The method of claim 3 , wherein the subject and the second subject each have fasting baseline triglyceride levels of 500 mg/dL to 1500 mg/dL.
10 . The method of claim 1 , wherein the subject is on statin therapy.
11 . A method of reducing a C-reactive protein level in a subject on statin therapy who has metabolic syndrome and fasting triglycerides of about 150 mg/dL to 499 mg/dL, the method comprising:
identifying the subject as having metabolic syndrome and as having fasting triglycerides of about 150 mg/dL to 499 mg/dL; and
thereafter orally administering to the subject about 4 g per day of ethyl eicosapentaenoate for a period of time effective to reduce a C-reactive protein (“CRP”) level in the subject.
12 . The method of claim 11 , wherein the reduction in CRP level is at least about 20%, about 27%, about 28%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, about 78%, at least about 80%, at least about 90%, or greater than about 90%.
13 . The method of claim 12 , wherein the reduction in CRP is compared to a second subject on statin therapy who has metabolic syndrome and fasting triglycerides of at least about 150 mg/dL to 499 mg/dL who has not received the ethyl eicosapentaenoate.
14 . The method of claim 11 , wherein the ethyl eicosapentaenoate comprises at least about 90%, at least about 95%, or at least about 96% of the fatty acids present.
15 . The method of claim 11 , wherein the subject is not administered DHA or an ester thereof.
16 . The method of claim 11 , wherein the period of time is at least about 12 weeks
17 . The method of claim 11 , wherein the step of orally administering the ethyl eicosapentaenoate further reduces one or more of:
a triglyceride level associated with the subject;
a non-HDL-C level associated with the subject; and
an apolipoprotein B level associated with the subject.
18 . The method of claim 11 , wherein the statin is one or more of atorvastatin, rosuvastatin and simvastatin.
19 . A method treating a subject with mixed dyslipidemia and metabolic syndrome on statin therapy, the method comprising:
identifying the subject as having mixed dyslipidemia and metabolic syndrome; and
thereafter administering to the subject about 4 dosage units per day, each dosage unit comprising about 900 mg to about 1.1 g of ethyl eicosapentaenoate for a period of at least about 12 weeks to effect a reduction in triglycerides.
20 . The method of claim 19 wherein the subject has baseline triglycerides of 200 mg/dl to less than 500 mg/dl.
21 . The method of claim 19 wherein the subject has coronary heart disease or a coronary heart disease risk equivalent.
22 . The method of claim 19 wherein administration for the period of at least about 12 weeks effects a reduction in one or more of: CRP, non-HDL-C, Apo B, LDL-C, total cholesterol, and VLDL-C.
23 . The method of claim 19 wherein the dosage units comprise capsules.