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|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)|
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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