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Methods and pharmaceutical compositions comprising a sglt2 inhibitor for treating or improving erectile dysfunction

Inactive Publication Date: 2018-04-19
BOEHRINGER INGELHEIM INT GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The pharmaceutical compositions, dosage forms, methods, and uses described in this invention have shown promising effects in treating and preventing diseases and conditions, such as erectile dysfunction and diabetes. Compared to pharmaceutical compositions with only one active ingredient, these combinations have advantages in terms of efficacy, dosage, frequency, and pharmacodynamic and pharmacokinetic properties. The use of these combinations can lead to improved glycemic control, reduced blood glucose concentrations, and reduced glucose AUC. The patent text also includes animal models for testing the pharmaceutical compositions and methods, such as mice, rats, and rats with experimentally induced diabetes. Overall, this invention provides novel and beneficial pharmaceutical compositions and methods for treating and preventing diseases, particularly those associated with diabetes.

Problems solved by technology

The rising prevalences of obesity and type 2 diabetes mellitus (T2DM) represent major challenges for global public health.
In addition, the presence of type 2 diabetes mellitus is associated with a two to five fold increase in cardiovascular disease risk.
Moreover, for patients with diabetes, the risk of erectile dysfunction increase with the duration of the condition and with increasing levels of glycated hemoglobin.
However, their use is not recommended in men who have recent history of stroke or myocardial infarction (within the last 6-8 weeks), or who have significantly low blood pressure, uncontrolled high blood pressure, unstable angina, severe cardiac failure, severe liver impairment or end-stage kidney disease requiring dialysis.
In view of the limitation of the existing therapies there is still an unmet medical need to treat erectile dysfunction, in particular in patients with diabetes mellitus.

Method used

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  • Methods and pharmaceutical compositions comprising a sglt2 inhibitor for treating or improving erectile dysfunction
  • Methods and pharmaceutical compositions comprising a sglt2 inhibitor for treating or improving erectile dysfunction

Examples

Experimental program
Comparison scheme
Effect test

example 1

Vivo Experiments

[0155]Animals Goto-Kakizaki (GK) rats has been shown to be a relevant experimental model of type II diabetes mellitus-associated erectile dysfunction. It was shown that erectile function in GK rats was markedly impaired (Oger-Roussel S, Behr-Roussel D, Caisey S, Kergoat M, Charon C, Audet A, Bernabe J, Alexandre L, Giuliano F. Bladder and erectile dysfunctions in the Type 2 diabetic Goto-Kakizaki rat. Am J Physiol Regul lntegr Comp Physiol 2014; 306:R108-R117). In that model, the impaired erectile function was partially improved by an acute single dose (0.3 mg / kg) of the PDE5 inhibitor sildenafil. Thus, GK rats represent a suitable model to investigate the pathophysiology of type 2 diabetes-associated erectile complications and to assess efficacy of new therapeutic agents targeting diabetic ED.

Methods

[0156]Adult male Wistar (Charles River, France) and age-matched GK rats (Metabrain Research, Chilly-Mazarin, France) were housed at least 7 days prior to the beginning o...

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PUM

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Abstract

The invention relates to methods for improving glycemic control and for treating erectile dysfunction in a patient diagnosed with prediabetes, type 1 diabetes mellitus, type 2 diabetes mellitus or metabolic syndrome wherein a SGLT2 inhibitor is administered to the patient. Furthermore the invention relates to a method for improving a treatment of erectile dysfunction in a male patient diagnosed with prediabetes, type 1 diabetes mellitus or type 2 diabetes mellitus characterized in that in addition to the treatment of erectile dysfunction a SGLT2 inhibitor is administered to the patient. The invention also relates a pharmaceutical composition comprising a SGLT2 inhibitor and a compounds selected from the group consisting of PDE5 inhibitors or alprostadil.

Description

TECHNICAL FIELD OF THE INVENTION[0001]The invention relates to a method for improving glycemic control in a male patient diagnosed with prediabetes, type 1 diabetes mellitus, type 2 diabetes mellitus or metabolic syndrome and with erectile dysfunction. Furthermore the invention relates to a method for treating erectile dysfunction in a male patient diagnosed with prediabetes, type 1 diabetes mellitus, type 2 diabetes mellitus or metabolic syndrome. In addition the invention relates to a method for improving a treatment of erectile dysfunction in a male patient diagnosed with prediabetes, type 1 diabetes mellitus, type 2 diabetes mellitus or metabolic syndrome. Furthermore the invention relates to a pharmaceutical composition comprising a SGLT2 inhibitor and one or more compounds selected from the group consisting of PDE5 inhibitors or alprostadil.BACKGROUND OF THE INVENTION[0002]The rising prevalences of obesity and type 2 diabetes mellitus (T2DM) represent major challenges for glob...

Claims

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Application Information

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IPC IPC(8): A61K31/7048A61K31/5575A61K45/06A61P3/10A61P15/10
CPCA61K31/7048A61K31/5575A61K45/06A61P3/10A61P15/10A61K2300/00
Inventor MAYOUX, ERIC WILLIAMSBEHR-ROUSSEL, DELPHINEGIULIANO, FRANCOIS
Owner BOEHRINGER INGELHEIM INT GMBH
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