Details for Patent: 8,524,698
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Title: | Methods of treating hypertriglyceridemia |
Abstract: | 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. |
Inventor(s): | Manku; Mehar (England, GB), Osterloh; Ian (Kent, GB), Wicker; Pierre (Mystic, CT), Braeckman; Rene (Richboro, PA), Soni; Paresh (Mystic, CT) |
Assignee: | Amarin Pharmaceuticals Ireland Limited (Dublin, IE) |
Filing Date: | Feb 25, 2013 |
Application Number: | 13/776,249 |
Claims: | 1. A method of reducing triglycerides comprising, orally administering daily for a period of at least about 12 weeks to a subject having a fasting baseline triglyceride level of at least 500 mg/dl a pharmaceutical composition comprising about 4 g of ethyl eicosapentaenoate and not more than about 4% docosahexaenoic acid or its esters, by weight of all fatty acids, wherein the pharmaceutical composition, when administered for twelve weeks to a first patient population having said baseline triglyceride level is effective to reduce a median triglyceride level in the first patient population by at least about 25% compared to a median triglyceride level observed in a second patient population having said baseline triglyceride level who has not received the pharmaceutical composition. 2. The method of claim 1, wherein the subject has a fasting baseline LDL-C from about 50 mg/dl to about 300 mg/dl. 3. The method of claim 1, wherein the subject has one or more of: a fasting baseline non-HDL-C of about 200 mg/dl to about 300 mg/dl, a fasting baseline total cholesterol of about 250 mg/dl to about 300 mg/dl, a fasting baseline VLDL-C of about 140 mg/dl to about 200 mg/dl, or a fasting baseline HDL-C of about 10 mg/dl to about 80 mg/dl. 4. The method of claim 1, wherein the pharmaceutical composition, when administered for twelve weeks to a first patient population having said baseline triglyceride and LDL-C levels is effective to reduce apolipoprotein B in the first patient population compared to median apolipoprotein B levels observed in a second patient population having said baseline triglyceride and LDL-C levels who has not received the pharmaceutical composition. 5. The method of claim 1, wherein the pharmaceutical composition, when administered for twelve weeks to a first patient population having said baseline triglyceride and LDL-C is effective to reduce VLDL-C in the first patient population compared to median VLDL-C levels observed in a second patient population having said baseline triglyceride and LDL-C levels who has not received the pharmaceutical composition. 6. The method of claim 1, wherein the subject has a fasting baseline triglyceride level of 500 mg/dl to 1500 mg/dl. 7. The method of claim 1 wherein the pharmaceutical composition is present in one or more dosage units. 8. The method of claim 7 wherein the dosage units are capsules. |