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Exendins to lower cholesterol and triglycerides

a technology of triglyceride and exendin, which is applied in the field of medicine, can solve the problems of greater risk of coronary heart disease, and achieve the effect of reducing total cholesterol and total cholesterol levels

Inactive Publication Date: 2011-10-27
ASTRAZENECA PHARMA LP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0010]Provided herein are methods for lowering total cholesterol levels, LDL-cholesterol levels, and triglyceride levels (e.g., fasting triglyceride levels) in patients in need thereof by administering to the patients formulations comprising sufficient amounts of at least one exendin, exendin agonist, or exendin analog agonist to maintain steady state average, geometric mean, or minimum plasma concentrations of the exendins, exendin agonists, or exendin analog agonists effective to reduce the total cholesterol levels, LDL-cholesterols levels, or triglyceride levels (e.g., fasting triglyceride levels) in the patients.
[0012]Provided herein are methods for preventing, treating, and reducing the risk of heart attacks and strokes in patients in need thereof by administering to the patients formulations comprising sufficient amounts of at least one exendin, exendin agonist, or exendin analog agonist to maintain steady state average, geometric mean, or minimum plasma concentrations of the exendins, exendin agonists, or exendin analog agonists effective to treat prevent, treat, or reduce the risk of heart attacks and strokes in the patients.
[0013]Provided herein are the use of exendins, exendin agonists, and exendin analog agonists in the manufacture of medicaments for use in lowering total cholesterol levels, LDL-cholesterol levels, and triglyceride levels (e.g., fasting triglyceride levels). Also provided herein are the uses of exendins, exendin agonists, and exendin analog agonists in the manufacture of medicaments in treating dyslipidemia and atherosclerosis, and in reducing the risk of heart attacks and strokes.

Problems solved by technology

Results of the Framingham study showed that the higher the cholesterol level, the greater the risk of suffering from coronary heart disease.

Method used

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  • Exendins to lower cholesterol and triglycerides
  • Exendins to lower cholesterol and triglycerides
  • Exendins to lower cholesterol and triglycerides

Examples

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examples

[0129]In order that the invention described herein may be more fully understood, the following examples are set forth. It should be understood that these examples are for illustrative purposes only and are not to be construed as limiting this invention in any manner.

[0130]The pharmacokinetics of a long-acting release formulation of exenatide was evaluated in a study in patients with Type 2 diabetes. The study population consisted of individuals with type 2 diabetes treated with a stable regimen of oral diabetes medications or managed with diet modification and exercise. Patients, male or female, had a mean age of 55±10 years with a mean body mass index (BMI) of about 34.9 kg / m2 at screening, and a mean HbA1c of 9.3±1.0% at screening. The 30 week study compared a 10 μg formulation of exenatide administered twice daily (BID) by subcutaneous (SC) injection and a 2 mg formulation of exenatide administered once weekly by subcutaneous (SC) injection. The study was also conducted, inter al...

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Abstract

Provided herein are pharmaceutical formulations containing exendins, exendin agonists, or exendin analog agonists that are administered at therapeutic plasma concentration levels over a sustained period of time to lower total cholesterol levels; to lower LDL-cholesterol levels; to lower triglyceride levels; to treat dyslipidemia; to treat and slow the progression of atherosclerosis; and to treat, prevent, and reduce the risk of heart attacks and strokes in patients. In the pharmaceutical formulations and methods of the invention, the exendin may be exendin-4, an exendin-4 agonist, or an exendin-4 analog agonist. The pharmaceutical formulations may be polymer-based pharmaceutical formulations that may be administered once weekly. An exemplary pharmaceutical formulation comprises 5% (w / w) of exenatide, about 2% (w / w) of sucrose, and about 93% (w / w) of a poly(lactide-co-glycolide) polymer, wherein the poly(lactide-co-glycolide) polymer is in the form of microshperes encapsulating the exenatide.

Description

FIELD OF THE INVENTION[0001]This application claims priority to U.S. Application No. 61 / 054,883 filed May 21, 2008, the disclosure of which is incorporated herein by reference.FIELD OF THE INVENTION[0002]The invention relates to the field of medicine, such as the use of exendins, exendin agonists, and exendin analog agonists to lower plasma lipid levels and improve cardiovascular health in patients.BACKGROUND OF THE INVENTION[0003]Research from experimental animals, laboratory investigations, epidemiology and genetic forms of hypercholesterolemia indicate that elevated cholesterol is a major cause of coronary heart disease. The Framingham Heart Study also established that high blood cholesterol is a risk factor for coronary heart disease. Results of the Framingham study showed that the higher the cholesterol level, the greater the risk of suffering from coronary heart disease. On the other end of the spectrum, coronary heart disease is generally uncommon at total cholesterol levels ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/26A61P9/10A61P3/06
CPCA61K9/5031A61K38/26A61K38/2278A61P3/06A61P9/10A61K38/179A61K47/34
Inventor FINEMAN, MARKMACCONELL, LEIGHTAYLOR, KRISTIN
Owner ASTRAZENECA PHARMA LP
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