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|Title:||Stable pharmaceutical composition and methods of using same|
|Abstract:||The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.|
|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)|
1. A method of treating a subject with fasting triglycerides of at least 500 mg/dl comprising, orally administering to the subject daily for a period of 12 weeks about 2500 mg to
about 5000 mg of ethyl eicosapentaenoate to lower triglycerides in the subject by at least 25% without increasing LDL-C by more than 5%.
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 baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.
4. The method of claim 1, comprising administering to the subject the pharmaceutical composition daily for the period of 12 weeks to effect a reduction in triglycerides of at least about 25% without increasing LDL-C in the subject.
5. The method of claim 1, comprising administering to the subject the pharmaceutical composition daily for the period of 12 weeks to effect a reduction in apolipoprotein B in the subject.
6. The method of claim 1, comprising administering to the subject the pharmaceutical composition daily for the period of 12 weeks to effect a reduction in VLDL-C in the subject.
7. The method of claim 1, wherein the composition is present in one or more dosage units.
8. The method of claim 7, wherein the dosage units are capsules.
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