Compositions and methods for lowering triglycerides without raising ldl-c levels in a subject on concomitant statin therapy
AssigneeAmarin Pharma, Inc.
InventorsIan Osterloh, Pierre Wicker, Rene Braeckman, Paresh Soni, Mehar Manku
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Abstract
In various embodiments, the present invention provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject in need thereof.
Claims19
A method of lowering triglycerides in a subject on stable statin therapy having baseline fasting triglycerides of about 200 mg/dl to about 500 mg/dl, the method comprising administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of ultra-pure EPA per day, wherein (1) upon administering the composition to the subject daily for a period of 12 weeks the subject exhibits at least 5% lower fasting triglycerides than a placebo controlled subject maintained on stable statin therapy without concomitant ultra-pure EPA for a period of 12 weeks, (2) the subject exhibits substantially no serum LDL-C increase, and (3) the placebo controlled subject also has baseline fasting triglycerides of about 200 mg/dl to about 500 mg/dl.
A method of lowering triglycerides in a subject having a 10 year risk of coronary heart disease, based on ATP III risk analysis, of at least 20%, the method comprising identifying a subject having a 10 year risk of coronary heart disease, based on ATP III risk analysis, of at least 20% and administering to the subject a triglyceride-lowering effective amount of ultra-pure E-EPA.
Dependencies are inferred from the claim text.