|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.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.