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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 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 inhibitors wherein a first dose level is from about 2 to about 13 mg/day, a second dose level is from about 5 to about 30 mg/day, and a third
dose level is from about 10 to about 50 mg/day; and wherein the MTP inhibitor is represented by: ##STR00004## or a pharmaceutically acceptable salt thereof or the piperidine N-oxide thereof, and wherein each dose level is administered to the subject for
about 1 to 4 weeks.
2. The method of claim 1 wherein the disorder is severe hypercholesterolemia.
3. The method of claim 1 wherein one or more of Total Cholesterol, LDL, fasting triglycerides (TG), VLDL, lipoprotein (a) (Lp(a)), and-lipoprotein B are reduced by at least 15%, compared to control levels.
4. The method of claim 1 wherein one or more of Total Cholesterol, LDL, fasting triglycerides (TG), VLDL, lipoprotein (a) (Lp(a)), and-lipoprotein B are reduced by at least 25%, compared to control levels.
5. The method of claim 1 wherein the MTP inhibitor is administered orally.
6. The method of claim 1 wherein said increasing dose levels further comprise a fourth dose level.
7. The method of claim 1 wherein said increasing dose levels further comprise a fourth and a fifth dose level.
8. The method of claim 1, wherein the increasing dose levels comprise a fourth dose level from about 20 to about 60 mg/day and a fifth dose level from about 30 to about 75 mg/day.
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