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Claims for Patent: 9,364,470

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Claims for Patent: 9,364,470

Title:Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Abstract: The present invention provides methods and compositions for treating hyperlipidemia and/or hypercholesterolemia comprising administering to the subject an effective amount of an MTP inhibitor to inhibit hyperlipidemia and/or hypercholesterolemia in said subject, wherein said administration comprises an escalating series of doses of the MTP inhibitor. In some embodiments the method comprises administering at least three step-wise, increasing dosages of the MTP inhibitor to the subject. In some embodiments, the method further comprises the administration of one or more other lipid modifying compounds.
Inventor(s): Rader; Daniel J. (Philadelphia, PA)
Assignee: The Trustees of the University of Pennsylvania (Philadelphia, PA)
Application Number:14/959,756
Patent Claims: 1. A method of treating a subject suffering from hyperlipidemia or hypercholesterolemia, the method comprising administering to the subject an effective amount of an MTP inhibitor, wherein said administration comprises at least three step-wise, increasing dose levels of the MTP inhibitor, wherein a first dose level is from about 0.02 to about 0.059 mg/kg/day, a second dose level is from about 0.06 to about 0.19 mg/kg/day, and a third dose level is from about 0.2 to about 0.59 mg/kg/day; and wherein the MTP inhibitor is represented by: ##STR00004## or a pharmaceutically acceptable salt thereof or the piperidine N-oxide thereof, and wherein the first dose level is administered for about two weeks, and wherein the second and third dose levels are each administered for about 4 weeks.

2. The method of claim 1, wherein administering increasing dose levels further comprises a maximum dose level of about 50 to about 75 mg/day.
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