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Claims for Patent: 8,618,135

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Claims for Patent: 8,618,135

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:13/046,118
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 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 about 5 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 apolipoproteins A-I, A-II, B, and E 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 apolipoproteins A-I, A-II, B, and E 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 7 wherein said fourth dose level is from about 20 to about 60 mg/day, and said fifth dose level is from about 30 to about 75 mg/day.

9. 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 2 to about 13 mg/day, administered to the subject for about 2 weeks; a second dose level is from about 5 to about 30 mg/day, administered to the subject for about 2 weeks to about 4 weeks; and a third dose level is from about 10 to about 50 mg/day, administered to the subject for about 2 weeks to about 4 weeks; and wherein the MTP inhibitor is represented by: ##STR00005## or a pharmaceutically acceptable salt thereof or the piperidine N-oxide thereof.

10. 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 2 to about 13 mg/day, administered to the subject for about 1 to about 12 weeks; a second dose level is from about 5 to about 30 mg/day, administered to the subject for about 4 weeks; and a third dose level is from about 10 to about 50 mg/day, administered to the subject for about 4 weeks; and wherein the MTP inhibitor is represented by: ##STR00006## or a pharmaceutically acceptable salt thereof or the piperidine N-oxide thereof.
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